Clinical Trials - Ronny Allan - Living with Neuroendocrine Cancer

24Mar 2023 by Ronny Allan No Comments

Nuclidium wins award to study NET radiopharmaceutical – Phase 1 Clinical Trial of TraceNET (TM)

What is TraceNETTM TraceNETTM is a a novel copper-based 'radiodiagnostic' for detecting neuroendocrine tumours (NET). The PET imaging agent candidate is the diagnostic component of NUCLIDIUM’s theranostic program, which comprises a true theranostic pair for diagnosing and treating NET patients, leveraging the company’s unique copper-based approach. The Phase 1 program for the diagnostic is the first step in its clinical development and is planned to commence in the first half of 2023. Nuclidium’s TraceNETTM program aims to overcome key limitations of existing radiodiagnostics and their corresponding therapeutics by increasing the sensitivity and diagnostic accuracy of NET imaging, including detecting metastases, while reducing the radiation burden for the patient. The TraceNETTM diagnostic consists of an imaging radioisotope (61Cu) and a somatostatin receptor (SSTR) antagonist-targeting molecule that binds with high affinity and specificity to…

16Mar 2023 by Ronny Allan No Comments

Experimental drug for Gastric NET – Netazepide

Clinical Trials, Treatment

Gastric NETs When I wrote my post entitled "Spotlight on Gastric Neuroendocrine Neoplasms", I explained what these were with some emphasis on the association with hypergastrinemia (elevated fasting serum gastrin levels) with Type 1 and 2 gNETs being differentiated by the settings in which this occurs. This oversecretion is not the same as so called carcinoid syndrome found in other gastrointestinal NETs. Many people with a Gastric NET will already have acid reflux related issues and many will be taking medications such as proton pump inhibitors. But I was surprised to find there was not an approved targeted medication that aims to decrease gastrin levels. It's true to say that somatostatin analogues (SSA) inhibit the secretion of many NET associated hormones including gastrin but SSAs are not routinely prescribed for…

09Mar 2023 by Ronny Allan 1 Comment

A tribute to the life and legacy of Miranda Filmer

Awareness, Clinical Trials, Inspiration

It's true to say that Neuroendocrine Cancer is an older person's disease, the epidemiology is clear on that. But I do see many young people diagnosed. In my own experience and observation, I normally see three main scenarios with younger people; an incidentally discovered appendiceal NET after appendicitis, someone with hereditary NET (e.g. Multiple Endocrine Neoplasia (MEN)) or an aggressive version of the disease. There are others but I find these are the most common scenarios I see in younger people. For me personally, as a father and a grandfather, it's often heart-breaking to read these stories. I wanted to write about one of the latter scenarios, a younger than average person with an aggressive version of our disease and one that eventually was the cause of her death. It…

05Mar 2023 by Ronny Allan No Comments

Treatment for Neuroendocrine Cancer: Beware of the alternatives

Clinical Trials, Diet and Nutrition, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship, Treatment

The Alternative HypeCancer Research UK warns of the risks in Alternative Therapies, and I pay great attention to what these guys say. I know from my association with their research capability, that they take an evidence-based approach and do not publish these things lightly.Please note Alternative Therapy is not the same as Complementary Therapy. Alternative therapy is something used instead of conventional approved treatment, complementary therapy is something used in addition to conventional approved treatments. Nonetheless, any therapy which is not approved may be dangerous to cancer patients. One of the big selling points advocates of alternative therapies use is to claim that conventional treatments are ’toxic’ while their favoured treatment is ‘natural’, implying that natural is somehow better. In analysis, that is a fallacy. It’s easy to get sucked into…

18Feb 2023 by Ronny Allan No Comments

Belzutifan for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), or Von Hippel-Lindau (VHL) Disease-Associated Tumors

Clinical Trials, Treatment

What is von Hippel-Lindau disease (VHL)?Von Hippel-Lindau disease (VHL) is an autosomal dominant disease that can predispose individuals to multiple neoplasms. Germline pathogenic variants in the VHL gene predispose individuals to specific types of benign tumors, malignant tumors, and cysts in many organ systems. These include central nervous system hemangioblastomas; retinal hemangioblastomas; clear cell renal cell carcinomas and renal cysts; pheochromocytomas, cysts, cystadenomas, and neuroendocrine tumors of the pancreas; endolymphatic sac tumors; and cystadenomas of the epididymis. What is Belzutifan (Welireg)?It is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. As an inhibitor of HIF-2α, belzutifan reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis and tumor growth.On August 13 2021, FDA approved belzutifan (Welireg) to treat adults who have several tumors associated with VHL. Specifically, the drug is approved to treat VHL-associated renal cell carcinoma (a type of kidney…

17Feb 2023 by Ronny Allan No Comments

A Phase II Clinical Trial of Nivolumab and Temozolomide for Neuroendocrine Neoplasms

Clinical Trials

What is Nivolumab (Opdivo)Nivolumab is a type of cancer treatment drug called an immunotherapy. It is a treatment for a number of different types of cancer. You might have it as part of a clinical trial for other types of cancer.What is Temozolomide (Temodal)Temozolomide is a type of chemotherapy. It is well known in Neuroendocrine Cancer as the TEM in CAPTEMTrial SummaryThe purpose of the trial. Treatment options are sometimes limited in patients with metastatic neuroendocrine neoplasms (NEN). The primary endpoint was response rate (using RECIST 1.1). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. Immune profiling was performed by mass cytometry to evaluate the effect on peripheral blood immune cell subsets."In summary, the combination of temozolomide and nivolumab showed promising activity in NEN, especially in lung…

31Jan 2023 by Ronny Allan No Comments

Phase I study of procaspase-activating compound-1 (PAC-1) in the treatment of advanced malignancies (incl NET)

Clinical Trials

Trial SummaryThis interesting trial is a multi-cancer effort including NET. The phase I clinical trial of Procaspase Activating Compound-1 (PAC-1), a drug that spurs programmed cell death in cancer cells, found only minor side effects in patients with end-stage cancers. The drug stalled the growth of tumors in the five people in the trial with neuroendocrine cancers and reduced tumor size in two of those patients. It also showed some therapeutic activity against sarcomas, scientists and clinicians report in the British Journal of Cancer. As of March 1, 2019, only patients with neuroendocrine tumors will be enrolled in Component 1 of this study. PAC-1 is taken orally on days 1-21 of a 28-day cycle. The maximum tolerated dose (MTD) of PAC-1 (5 dose levels) will be determined using a modified-Fibonacci…

14Jan 2023 by Ronny Allan No Comments

Cancer Ablation

Clinical Trials, Patient Advocacy, Treatment

What is Cancer Ablation?This is a minimally invasive surgical method to treat solid cancers. Special probes are used to “burn” or “freeze” cancers. Computed Tomography (CT), Ultrasound (US) or Magnetic Resonance Imaging (MRI) is used to guide and position the needle probe into the tumour. This requires only a tiny hole, usually less than 3 mm via which the probe is introduced. When the probe is within the cancer it is attached to a generator which “burns” or “freezes” the cancer. “Burning” refers to increasing the temperature of the tumour to such a level that cancer cells die. This is usually achieved by radio frequency probes, referring to the type of energy used to increase the temperature. “Freezing” refers to cryoablation which decreases the temperature to -40 C (-40 F)…

08Jan 2023 by Ronny Allan 2 Comments

EUS Guided Ablation for small pancreatic NETs (Less than 2cm)

Clinical Trials, Patient Advocacy

To burn or not to burn?I once wrote a post about Pancreatic NET "to cut or not to cut". You can read that here. Surgery for small pancreatic NETs remains controversial with most guidelines and study guidelines recommending surveillance for small primary tumours less than 2cm. There are exceptions to that, e.g. preventative surgery if the tumour is threatening important vessels and for functional cases where the surgery is palliative in nature. Contrast that against some patient perspectives where they just want it cut out (and some will 'surgeon-shop' until they find someone who will).Most pancreatic NET are lower grades (e.g. Grade 1 and 2) well differentiated, most are non-functional, many are localised. Functional tumours such as Insulinoma are mostly small and localised. A lack of sensitive and specific markers that…

03Jan 2023 by Ronny Allan 2 Comments

RonnyAllan.NET – a review of 2022

Awareness, Clinical Trials, Diet and Nutrition, Inspiration, Living with Neuroendocrine Cancer, Newsletters, Patient Advocacy, Survivorship, Travel with Ronny, Treatment

ReviewIn 2022, my pet project (my blog) hit 2 million views in early November – that was a major boost. It takes 3-4 years to get a million hits based on current performance. To be honest, I’m still flabbergasted by reaching one million in 2018. It just kinda happened! I am grateful for every single view. 2022 was a challenging year, mainly because the pandemic had some latent impact on my social media activity and also in terms of growth. 2020 and 2021 were slower than normal but 2022 has seen some pickup. Some of it is due to less writing but much is due to a change in Facebook algorithms which affected many ‘pages’ reducing their scope (the more cynical might say it was done to drive advertising revenue but …….). 2022…

14Dec 2022 by Ronny Allan No Comments

A multicentre validation of the NETPET score (Dual [68Ga]DOTATATE and [18F]FDG PET/CT in patients with metastatic GEPNENs

Clinical Trials, Patient Advocacy, Survivorship, Treatment

Background It's normally the case that the higher the grade/Ki67 in Neuroendocrine Neoplasms (NENs), the less likely the tumours will have somatostatin receptors and therefore be able to take advantage of somatostatin receptor PET (SSTR PET) as the gold standard in nuclear imaging. This is why most grade 3 NENs will receive [18F]FDG PET/CT which finds glycolytic activity in the tumour and predicts an aggressive disease course and normally a higher histological grade. It can also add to prognostic outcomes, which in turn can add to therapy choice decisions. There is an overlap though, particularly with the recognition of well-differentiated Grade 3 Neuroendocrine Tumours (NETs). It is known that some glycolytic activity might be present in some well-differentiated NETs, in particular, grade 3 and the upper range of 2 Neuroendocrine…

12Dec 2022 by Ronny Allan No Comments

Stereotactic body radiation therapy (SBRT) in the treatment of Neuroendocrine Neoplasms

Clinical Trials, Treatment

What is Stereotactic Body Radiation Therapy (SBRT)? External beam radiotherapy has been around for a while. But the next generation equipment and techniques are gradually being deployed. It's a confusing area with many synonyms which I found when I wrote about the subject in a treatment summary for patients. Some of the sub-components/synonyms may be familiar to you and are often used interchangeably with SBRT; but are actually a brand name (e.g.Cyberknife) or a type (e.g. Proton Beam). You will not find SBRT mentioned in any Neuroendocrine Neoplasms (NENs) guidelines and that's because it is not a "standard of care" for this disease. If it is not a standard of care, why did I include SBRT and various techniques in the above summary? I was prompted to include this after…

01Dec 2022 by Ronny Allan No Comments

In the news – new Neuroendocrine Tumour PET Fluorine-18 based ‘tracer’

Clinical Trials, Patient Advocacy

This should be of interest, particularly to Canadians. (Not to be confused with 18F-FDG which is a different scan). For people waiting for imaging tests to diagnose neuroendocrine cancer, time is of the essence. Now, thanks to researchers at the University of Alberta, a new medical imaging agent for PET scans promises to reduce wait times, while costing less to produce and possibly revealing more of some types of cancer tumors. Ralf Schirrmacher, an oncology imaging professor and member of the Cancer Research Institute of Northern Alberta, and his team at the Medical Isotope and Cyclotron Facility on the U of A's South Campus have been using a state-of-the-art cyclotron—a machine that already supplies the province with medical isotopes used in diagnostic scans—to create a new imaging compound that will…

02Nov 2022 by Ronny Allan 1 Comment

Alpha-emitter PRRT: Phase 1/2 Study of AlphaMedix™ (²¹²Pb-DOTAMTATE) in Adult Subjects With SSTR positive NET

Clinical Trials

Ebrahim S Delpassand, Izabela Tworowska, Rouzbeh Esfandiari, Julien Torgue, Jason Hurt, Afshin Shafie and Rodolfo Núñez Journal of Nuclear Medicine, January 2022, jnumed.121.263230; DOI: https://doi.org/10.2967/jnumed.121.263230 What is Alpha-emitter PRRT? Substitution of an alpha emitter (e.g. ²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumour cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug. Trial Summary AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications, i.e. it's a type of PRRT. This drug addresses an…

11Oct 2022 by Ronny Allan No Comments

New test of pancreatic cysts to help with cancer detection

Clinical Trials, Patient Advocacy, Treatment

With NETs, particularly pancreatic NETs, due to a lack of efficient prognostic markers, it is difficult to identify which cases are more likely to metastasise than others. Identifying whether cysts will turn cancerous is also another area requiring a screening program as a standard of care to monitor. Molecular testing is advancing and this test I'm reporting here looks like good news in the case of assessing the risks of pancreatic cysts. Pancreatic cysts are common. For example, up to 15% of the U.S. population will develop a pancreatic cyst at some point in their lives. Most of these cysts are benign, but a small fraction will transform into cancer, including pancreatic NET. A molecular test developed by the University of Pittsburgh is able to distinguish benign pancreatic cysts from…

06Oct 2022 by Ronny Allan 3 Comments

Study of Lu-177-DOTATATE (Lutathera) in Combination With PARP Inhibitors in Inoperable/Metastatic Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Clinical Trials

PARP inhibitor with PRRT clinical trials update. 1. NIH Trial SummaryA phase I/II clinical trial at the NIH Clinical Center evaluates the effectiveness of a combination of two agents that may work in complementary ways to target inoperable or metastatic neuroendocrine tumoors. One agent, lutathera, emits radiation inside the body, causing DNA damage, and the second agent, olaparib, a PARP inhibitor, blocks the repair of DNA breaks. The trial commences in Oct 2022 running for approximately 2 years 9 months. What is Lutathera?It's a type of Peptide Receptor Radionuclide Therapy (PRRT) and has been in use for some years as a standard of care (mostly second line). Read more click here.What is Olaparib and what does it do in conjunction with Lutathera?Olaparib (AZD-2281, trade name Lynparza) is an FDA-approved targeted therapy for cancer, developed…

03Oct 2022 by Ronny Allan 2 Comments

Neuroendocrine Cancer: Glossary of Terms

Awareness, Clinical Trials, Diet and Nutrition, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship, Treatment

Welcome to my Neuroendocrine Cancer Glossary of Terms list providing a source of meanings for acronyms and medical terms, all sourced from top Neuroendocrine Cancer and general cancer sites. How to use this list: 1. If your term begins with an A, click on A to find all terms beginning with A. Select your term from the list. 2. For numerical terms, please click on the hashtag (#) symbol in the A-to-Z strip. 3. The term definition including acronym or abbreviation will be given in full along with any of my published articles containing that term as long as I have tagged it on my website to display in the list. Please note I'm constantly working on the repository to clean up all definitions, adding and removing links where necessary,…

30Sep 2022 by Ronny Allan No Comments

Prospective Phase II Trial of Prognostication by 68Ga-NOTA-AE105 uPAR PET in Patients with Neuroendocrine Neoplasms: Implications for uPAR-Targeted Therapy

Clinical Trials

Summary A novel PET radiotracer can accurately assess the presence of a biomarker that indicates the level of tumor aggressiveness in neuroendocrine neoplasms (NENs). According to research published in the September issue of The Journal of Nuclear Medicine, the detection of the biomarker provides useful information for physicians to provide personalized care for patients with NENs and may also serve as a potential target for peptide radionuclide therapy (PRRT) for NEN patients.What is uPAR? Tumorigenesis (the production or formation of a tumour or tumours) is closely related to the loss of control of many genes. Urokinase-type plasminogen activator receptor (uPAR), a glycolipid-anchored protein on the cell surface, is controlled by many factors in tumorigenesis and is expressed in many tumor tissues. What is different about targeting uPAR instead of somatostatin receptors? uPAR expression…

23Sep 2022 by Ronny Allan No Comments

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (MAST)

Clinical Trials

A Study of CF33-hNIS (VAXINIA), an Oncolytic Virus, as Monotherapy or in Combination With Pembrolizumab in Adults With Metastatic or Advanced Solid Tumors (MAST)Neuroendocrine Neoplasms are considered solid tumours.Imugene Limited, a clinical-stage immuno-oncology company, and City of Hope, one of the largest cancer research and treatment organizations in the United States, today announced that the first patient was dosed in Phase 1 clinical trial evaluating the safety of novel cancer-killing virus CF33-hNIS VAXINIA when used in people with advanced solid tumors. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.Interestingly, the principal investigator is listed as a NET Specialist. No conclusions should be drawn from this knowledge, and I have no information to suggest…

14Sep 2022 by Ronny Allan No Comments

Clinical Trial: Phase 1b/3 Targeted Alpha-Emitter PRRT RYZ101 (Ac225)

Clinical Trials

Update 21st March 2023 - RayzeBio Completes Phase 1b Enrollment in ACTION-1 Study, Evaluating RYZ101 (Actinium-225 DOTATATE) in Neuroendocrine Tumors -- 17 patients were enrolled at the highest dose and no dose limiting toxicities (DLTs) were observed -- RYZ101 positioned to be the first approved Actinium-225 radiopharmaceutical therapy for the industry Author's note: Please note this is an evaluation phase, the full trial will eventually progress with up to 218 participants.What is Alpha-emitter PRRT? Substitution of an alpha emitter (e.g. ²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumour cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side…

01Sep 2022 by Ronny Allan No Comments

Management of asymptomatic sporadic non-functioning pancreatic neuroendocrine neoplasms no larger than 2 cm: interim analysis of prospective ASPEN trial

Clinical Trials, Treatment

One of the most controversial subjects in Neuroendocrine Neoplasms is the management of small non-functional (asymptomatic) pancreatic NETs (NF-PanNEN). In the most general terms, surgery is not recommended in tumours less than 2cm. Allowances are made for those who are functional (i.e. symptomatic with one of several syndrome possibilities) or where the tumour is threatening important vessels (i.e. pre-emptive surgery). Normally watching and waiting is recommended. I wrote more detail in an earlier blog - Pancreatic Neuroendocrine Tumours - to cut or not to cutSome patients opt (or push for) a non-guideline surgery regardless and as one other patient advocate put it, "they will surgeon shop until they find one who will do it". While the guidelines are just that (guidelines), decisions on surgery in such cases must be carefully considered…

30Aug 2022 by Ronny Allan No Comments

Prospective phase II trial of [68Ga]Ga-NODAGA-E[c(RGDyK)]2 PET/CT imaging of integrin for prognostication in patients with neuroendocrine neoplasms

Clinical Trials

August 25, 2022 -- A new gallium-68 PET radiotracer appears effective for predicting higher risk of disease progression and mortality in patients with neuroendocrine tumors, according to a study published August 18 in the Journal of Nuclear Medicine. Conclusion: Tumor lesion uptake of 68Ga-NODAGA-E[c(RGDyK)]2 was evident in patients with all grades of NEN. High uptake was associated with a poorer prognosis. Further studies are warranted to establish if 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT may become a prediction tool for identification of patients eligible for treatments targeting integrin αvβ3. Why is this different to regular Ga68 Dotatate? In the simplest of terms, Ga68 Dotatate is targeting somatostatin receptors which are known to be expressed by most NETs, it can help indicate if treatment using somatostatin analogue therapy is feasible. Integrin αvβ3 recognizing cell surface integrins is upregulated on endothelial…

05Aug 2022 by Ronny Allan No Comments

Curtis Crump: “If I’m going down, it won’t be without a fight.”

Clinical Trials, Inspiration, Patient Advocacy, Survivorship

Curtis Crump: Credit MD Anderson Cancer Center Curtis Crump has an amazing story to tell. Given 6 months to live, he refused to accept that prognosis and looked elsewhere. He found a top hospital that directed him to an established clinical trial. Although the story I am attaching says "Neuroendocrine Tumors" throughout, with that prognosis and the treatment he received (chemotherapy and immunotherapy), I'm reasonably confident he had a Neuroendocrine Carcinoma (Colon primary) or a Grade 3 Well Differentiated NET. Nonetheless, his story is relevant to many people's experiences across the broad spectrum of Neuroendocrine Neoplasms (NENs). And if I am right in my assumption, even with a poorly differentiated type, there is the hope of a better prognosis. Wishing Curtis the very best. Read his story below.(Please see my disclaimers…

27Jul 2022 by Ronny Allan No Comments

Survival Outcomes in Metastatic Gastroenteropancreatic Neuroendocrine Tumor Patients receiving Concomitant 225Ac-DOTATATE Targeted Alpha Therapy and Capecitabine: A Real-world Scenario Management Based Long-term Outcome Study

Clinical Trials

Introduction I've written about both 225Ac-DOTATATE targeted alpha therapy (TAT) and Capecitabine before but never as a concomitant pair (combo). So, when this Indian study came up on my radar, I felt it was a useful addition to my website adding to my existing targeted alpha therapy portfolio of information. India appears to be using more of this type of PRRT than any other country. Read more about targeted alpha therapy by clicking here or on the photo below. [caption id="attachment_12014" align="aligncenter" width="1024"] Click on the photo to read[/caption] Read more about Capecitabine (combo with Temozolomide) by clicking here or on the photo below. [caption id="attachment_33477" align="aligncenter" width="640"] Click on the photo to read[/caption] The abstract from the Indian study is posted and cited below. Abstract Rationale: Although the short-term results…

20Jul 2022 by Ronny Allan No Comments

Assessment of Clinical Response Following Atezolizumab and Bevacizumab Treatment in Patients With Neuroendocrine Tumors: A Nonrandomized Clinical Trial

Clinical Trials

BackgroundWell differentiated NETs have been described as an "immunological desert" in recent years mainly due to the poor response rate data coming out of clinical trials of immunotherapy drugs. Poorly differentiated NEC has favoured better but mainly in the more obscure types. Which is why these data of a combo treatment containing one immunotherapy drug caught my eye. What is atezolizumab? It is a type of monoclonal antibody and a type of immune checkpoint inhibitor. It's a Programmed cell death protein -1 (PD-1)/ Ligand 1 (PD-L1) inhibitor. A drug that binds to the protein PD-L1 to help immune cells kill cancer cells better and is used to treat many different types of cancer, including cancers that express PD-L1. Atezolizumab is used alone or with other drugs to treat certain types of…

19Jun 2022 by Ronny Allan No Comments

Clinical Trial: Triapine and Lutetium Lu 177 Dotatate for Neuroendocrine Tumors

Clinical Trials

What is PRRT? I'm guessing most of my readers know what Peptide Receptor Radiotherapy (PRRT) is. But for those new to this field, read more here What is Triapine? Triapine is a ribonucleotide reductase (RNR) inhibitor, I.e. it helps repair DNA. When I research this drug, I can see it is used in numerous examples of clinical trials in an anti-cancer setting alongside radiotherapy and chemotherapy, in many cancers. Triapine in NET There is currently a trial of Triapine with Lutathera (PRRT) (11 major US hospitals). This study was testing the hypothesis that triapine is an effective radiation sensitizer that can be safely combined with peptide receptor radionuclide therapy and can improve antitumor activity of Lutetium Lu 177 Dotatate, e.g. increase the objective response rate (ORR) above that found in…

15Jun 2022 by Ronny Allan No Comments

CAPTEM for Neuroendocrine Tumours

Clinical Trials

What is CAPTEM? Capecitabine is an oral drug used alone or with other drugs to treat certain types of colorectal cancer and breast cancer. It is also being studied in the treatment of other types of cancer including in combination with a second drug. Capecitabine is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Xeloda is a type of antimetabolite. Also called Xeloda.Temozolomide is an oral drug used to treat adults with certain types of brain tumors. It is also being studied in the treatment of other types of cancer including in combination with a second drug. Temozolomide damages the cell’s DNA and may kill cancer cells. It is a type of alkylating agent. Also called Temodar.Capecitabine (brand name Xeloda) plus Temozolomide (brand…

08Jun 2022 by Ronny Allan No Comments

Clinical Trial: Dostarlimab, anti–PD-1 monoclonal antibody in Neuroendocrine Carcinoma

Clinical Trials, Treatment

BackgroundFollowing the Americal Society of Clinical Oncology (ASCO) conference in June 2022 (ASCO is the biggest Oncology event in the world), the media widely featured the results of the Phase 2 clinical trial of the drug Dostarlimab, an anti–PD-1 monoclonal antibody. The media often looks for headline-grabbing stories and this was one of them. One UK TV outlet said they may have found the cure for cancer, which is a reckless statement when you look at the size and boundary of the clinical trial referenced. The detail is, that this was a phase 2 trial for "rectal adenocarcinoma", but specifically locally advanced mismatch repair-deficient (dMMR) rectal cancer, allowing them to avoid surgery, chemotherapy, and radiation, at least for the time being. Nonetheless, the complete response in all 12 was clinically…

25Apr 2022 by Ronny Allan 2 Comments

Histotripsy: A new technique which destroys cancer using soundwaves (now in Clinical Trials)

Clinical Trials, Treatment

Illustration of histotripsy technology. Image courtesy of Medicine at Michigan Magazine. A new technique that destroys cancer using soundwaves. It also spurs the immune system to kill off any of the tumour left, scientists have revealed. The non-invasive treatment only needs to be partially effective to stop the cancer spreading.It is currently being tested on human liver cancers in the US and Europe following successful trials in rats. The team from the University of Michigan showed the non-invasive sound technology is able to prevent further spread with no evidence of recurrence or metastases in the majority of cases. The treatment, called histotripsy, noninvasively focuses ultrasound waves to mechanically destroy target tissue with millimetre precision. In many cases, the entirety of a cancerous tumour cannot be targeted directly in treatments due to…

16Mar 2022 by Ronny Allan 4 Comments

Electronic Autoinjector for Somatuline® Autogel® / Somatuline® Depot (lanreotide)

Clinical Trials, Patient Advocacy, Treatment

Breaking News It doesn't seem that long since we got the new improved injection delivery system for the current model of Lanreotide. I had to look at my blog articles for the announcement of that and was surprised it had already been 3 years. It may be a shorter time period for many though, UK was near the front of that rollout. I personally found the new injection a better experience and I know the nurses were happier too. However, I also know there was some disappointment that the injection gauge and length were the same and therefore there was little change for many in terms of the 'experience'. Speaking from a personal perspective, there was not sufficient change for me to consider moving to self-inject. I know (at least…

10Mar 2022 by Ronny Allan 3 Comments

Clinical Trial: Mycapssa (octreotide capsules) for Neuroendocrine Tumours

Clinical Trials, Treatment

The delayed-release capsules contain 20mg of octreotide. Update 20th Dec 2022The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion for orphan designation for the use of Mycapssa® in the treatment of carcinoid syndrome associated with neuroendocrine tumors (NET).Orphan designation in the European Union (EU) is granted by the European Commission (EC) within 30 days of a positive opinion being issued by the COMP. This designation provides certain regulatory and financial incentives including but not limited to product market exclusivity for ten years in the EU following regulatory approval. THIS IS NOT AN APPROVAL but it moves this one step closer. Update 14th July 2022. Amryt Receives Orphan Drug Designation from the FDA for Mycapssa® (oral octreotide) for the Treatment of Carcinoid Syndrome. The details of Phase 3 clinical…

07Mar 2022 by Ronny Allan No Comments

Clinical Trial: Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors

Clinical Trials, Treatment

An interesting trial centred on SW USA. The use of CAPTEM following surgery in high-risk pancreatic NETs (G2/G3 well-differentiated). Also includes the use of NETest at 3 time points, which is very interesting considering the recent withdrawal of Chromogranin A from US NET Guidelines. (Read about NETest here). Randomized Phase II Trial of Postoperative Adjuvant Capecitabine and Temozolomide versus Observation in High-Risk Pancreatic Neuroendocrine Tumors (S2104) is a recently activated National Clinical Trials Network randomized phase II trial designed to compare CAPTEM chemotherapy versus observation following resection of pNETs (see Figure 2). Patients with well-differentiated grade 2 or 3 (Ki-67 up to 55%) pNETS with a Zaidi score of ≥3 who underwent resection (or ablation) for either localized disease with or without up to five liver metastases are eligible for…

09Jan 2022 by Ronny Allan No Comments

Clinical Trial: Lutathera and ASTX727 in Neuroendocrine Tumours (LANTana)

Clinical Trials, Patient Advocacy, Treatment

What is the aim of this clinical trial?The aim of this single location trial in Imperial College London is to determine whether pre-treatment with ASTX727 results in re-expression of SSTR2 in patients with metastatic NETs, using 68Ga-DOTA-TATE to image epigenetic modification of the SSTR2 locus allowing subsequent treatment with Lutathera(i.e. PRRT). Patients entered into the study will receive ASTX727 orally up to 3 to 8 days prior to receiving Lutathera treatment. What is ASTX727?Oral Decitabine and Cedazuridine (ASTX727) is a DNA methyltransferase (DNMT) inhibitor currently being used in a trial to facilitate oral treatment of certain drugs for adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).This is extremely technical, but from a study conducted by scientists at Imperial College London, they acknowledged that significant number of…

03Jan 2022 by Ronny Allan No Comments

Blog review and top 10 for 2021: RonnyAllan.NET

Awareness, Clinical Trials, Diet and Nutrition, General, Humour, Inspiration, Living with Neuroendocrine Cancer, Patient Advocacy, Survivorship, Treatment

I should be happy with over a quarter of a million views in 2021 but I'm not! Like 2020, my figures are down on previous years as the pandemic seems to have changed viewing habits, not to mention my own bandwidth during this period. I created my private Facebook group not that long before the pandemic started, and I think that has been playing a part as huge chunks of my time has been taken up on that special project. I also changed the nature and the type of posts on my "Ronny Allan" Facebook page, which led to fewer outlets for my blog posts. Hopefully, 2022 will be a better year. However, just as I was totally astonished to have been able to accumulate a million views of my…

23Nov 2021 by Ronny Allan 2 Comments

177Lu-DOTA-LM3 – a novel radionuclide therapy proven safe and effective to treat neuroendocrine neoplasms (NEN)

Clinical Trials, Treatment

This is all the information available and further details to follow if any is published. Remember, this is not yet an approved treatment, nor is it widely available. Only ever used in experimental/compassionate situations. Not even entered the formal clinical trial system. So even if there was a plan to develop and deploy it (which as far as we know there isn't), and it gained approval, it would be some years before we see it. Whenever I post about a new trial, some people get excited without understanding that these new treatments and capabilities can very often take years to come to fruition and it's also possible that clinical trials can be halted, or that national approval agencies will not approve the final product. Please bear that in mind when…

13Nov 2021 by Ronny Allan 6 Comments

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With GEP-NET (SORENTO)

Clinical Trials, Treatment

Some of the key differences between Lanreotide and Octreotide long-acting are:1. Octreotide long-acting needs constituting prior to administration - Lanreotide comes prefilled. 2. Octreotide long-acting is administered intra-muscular, Lanreotide is deep subcutaneous. 3. I probably should add Octreotide LAR cannot be self-injected but Lanreotide can. I suspect this type of delivery system may open up that possibility for Octreotide LAR. So, this clinical trial caught my eye. A version of octreotide long-acting which is prefilled and given subcutaneously. Plus, the manufacturers say it has a much higher bioavailability than the standard product Sandostatin LAR (bioavailability is the proportion of a drug or other substance which enters the circulation when introduced into the body and so is able to have an active effect).CAM2029 might therefore be considered a generic of Sandostatin LAR but better…

26Oct 2021 by Ronny Allan No Comments

CAR-T clinical trials for Neuroendocrine Cancer

Clinical Trials, Treatment

What is CAR-T?CAR-T – chimeric antigen receptor T-cell – therapy is specifically developed for each individual patient and involves reprogramming the patient’s own immune system cells which are then used to target their cancer., i.e. it's an immunotherapy. It is a highly complex and potentially risky treatment, but it has been shown in trials to cure some patients, even those with quite advanced cancers and where other available treatments have failed.The treatment involves several steps over a number of weeks. First the patient’s blood is taken and is sent off to the manufacturer’s laboratory. Here the patient’s blood is ‘trained’ to fight the cancer cells. The CAR-T blood is then transported back to the hospital and the patient is administered with the CAR-T to treat their condition.It has not been deployed in…

17Oct 2021 by Ronny Allan No Comments

In the land of small tumours, there is still a lot of work to do!

Awareness, Clinical Trials, Patient Advocacy, Treatment

I like reading the words of Dr Mark Lewis, an Oncologist and a Neuroendocrine Tumour (NET) patient himself (with MEN1). He always delivers with "enthusiastic vigour", a term he reduces to "brio" (which I had to google!)His article as usual sets a scene and he has form for looking back in the history of NETs. I'm sure he does this as it can often illustrate just how much clinical progress has been made since way back then. And that is the purpose of the recent article entitled "Continuing the Odyssey in the Land of Small Tumors". He quotes from a 1987 article written by Dr Charles Moertel entitled "An Odyssey in the Land of Small Tumors" and I suspect he selected this article from Dr Moertel as he too writes…

21Sep 2021 by Ronny Allan No Comments

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) – (COMPOSE)

Clinical Trials

Garching / Munich, October 27, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for ITM-11 (n.c.a. 177Lu-edotreotide), an investigational radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE. The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. The purpose is to bring new and promising medicines to patients sooner. The Fast Track designation enables ITM to have more frequent interactions with the FDA to discuss the ITM-11 development path. It also allows rolling review of the new drug application (NDA)…

18Sep 2021 by Ronny Allan No Comments

New Clinical Trial – Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

Clinical Trials

When I see a trial for Gastroenteropancreatic NETs (GEPNETs), I know that BP (Bronchopulmonary) NETs (includes Lung) are not included. When you look at the approval wording for the major treatments in use (PRRT Lutathera, Lanreotide), they appear to use the term GEPNETs making BP NETs the poor relative. Clearly there’s highly complex reasons why NETs react differently in different parts of the body. I can see that BP NET patients were involved in clinical trials for both of the mainstream treatments listed above. The drug approval process is also highly complex, and I can see from the wording that functional BP NETs with carcinoid syndrome can qualify at least for somatostatin analogues (Lanreotide and Octreotide). That is not to say BP NET patients cannot get access to these treatments, I…

12Sep 2021 by Ronny Allan 1 Comment

The GRAIL multi-cancer early detection test study

Clinical Trials

Edit 13th Aug 2021. Major Announcement from UK. The NHS will today launch the world’s largest trial of a revolutionary new blood test that can detect more than 50 types of cancer before symptoms appear. The first people to take part will have blood samples taken at mobile testing clinics in retail parks and other convenient community locations. The Galleri(tm) test checks for the earliest signs of cancer in the blood and the NHS-Galleri trial, the first of its kind, aims to recruit 140,000 volunteers in eight areas of England to see how well the test works in the NHS. Read more here. "The earlier that cancer can be found, the higher the chance of successful treatment and survival. Yet, too often cancer goes undetected until it has progressed…

11Sep 2021 by Ronny Allan No Comments

Neuroendocrine Tumors: Targeted Therapies – Update from NET Specialist Diane Reidy-Lagunes, MD, Memorial Sloan-Kettering Cancer Center – August 2021

Clinical Trials, Patient Advocacy, Survivorship, Treatment

Background. For those who want a quick run through of Neuroendocrine Tumors from diagnosis to selection of treatment, about the treatments themselves plus what is the Future Directions in the Management of Neuroendocrine Tumors. There are 8 episodes, and each is around 3-5 minutes long. I personally found them very useful and in a language understandable to patients. Great job by OncLive and Dr Reidy-Lagunes! Episode 1 - Understanding the Diagnosis and Prognosis of Neuroendocrine Tumors Diane Reidy-Lagunes, MD, provides an overview of neuroendocrine tumors, along with specific considerations for optimal diagnosis and prognostication. Understanding the Diagnosis and Prognosis of Neuroendocrine Tumors (onclive.com) Episode 2 - Neuroendocrine Tumor Pathogenesis and Molecular Testing Expert insight on the pathogenesis of neuroendocrine tumors and the best use of molecular testing to inform treatment decisions.Neuroendocrine Tumor Pathogenesis…

13Jul 2021 by Ronny Allan No Comments

Every picture tells a story (point, click, read)

Awareness, Clinical Trials, Diet and Nutrition, Inspiration, Living with Neuroendocrine Cancer, Newsletters, Patient Advocacy, Survivorship, Treatment

I always try to use graphics for a number of pictures, I admit mainly to catch people's attention but also because sometimes a picture on its own tells a story or at least provides a great introduction to one. If the picture catches your eye, clicking on will take you to the text. This post will auto update as new blogs are published. thanks for reading and sharing! Scroll, point, click, read, share! Click here and answer all questions to join my private Facebook group Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Thanks for reading. Ronny I’m also active on Facebook. Like my page for even more news. Help me build up my new site here –…

22May 2021 by Ronny Allan 2 Comments

Clinical Trial: Survivin Long Peptide Vaccine in Treating Patients With Metastatic Neuroendocrine Tumors

Clinical Trials

Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email What are cancer vaccines? I remember seeing a comment by a NET Specialist on twitter saying, "We need vaccines". This was in response to a tweet from another NET Specialist reporting dismal data from an immunotherapy drug for Neuroendocrine Carcinomas. In 2020/2021, the word vaccine has been used a lot, but this specialist was not inferring anti-viral treatment, he was talking about "cancer vaccines", an emerging discipline in science where vaccines act as an immunostimulant to treat cancer. This prompted me to look around and found this trial which may be of interest to you. However, before anyone gets too excited, this is very early days in the study of…

10May 2021 by Ronny Allan 3 Comments

Neuroendocrine Tumour (VMT-𝛼-NET) programs

Clinical Trials

Viewpoint Molecular Targeting Announces First Neuroendocrine Tumor Patients Dosed with Therapeutic IntentJan 23, 2023In early December, VMT-α-NET, the Company’s lead drug for the treatment of neuroendocrine tumors was administered to patients in India on a compassionate use basis, independent of a planned US trialNo acute adverse reactions were observed in the first 10 days post administration and patients remain stable and in good conditionCORALVILLE, Iowa –Viewpoint Molecular Targeting®, Inc., a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents, today announced the first dosing of two neuroendocrine tumor patients with therapeutic intent. VMT-α-NET, which is being developed for the treatment and diagnosis of somatostatin receptor subtype 2 (SSTR2) expressing neuroendocrine tumors, was administered to the patients in early December. The dosed patients were diagnosed with confirmed-advanced somatostatin expressing…

30Apr 2021 by Ronny Allan 1 Comment

Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumours

Clinical Trials

For some time now, I've been watching the development of PET scans for Neuroendocrine Neoplasms (NENs). I use the term 'Neoplasms' because there are different strategies for well and poorly differentiated types, Neuroendocrine Tumour (NET) and Neuroendocrine Carcinoma (NEC) respectively.It's known that most NETs have somatostatin receptors which makes tumours be seen better on somatostatin receptor-based imaging e.g. 68Ga-DOTATATE or 64Cu DOTATATE, but more aggressive types tend not to have working somatostatin receptors and are better seen on regular PET, i.e. 18F-FDG PET/CT. However, nothing in NENs is simple and there's always outliers. This has been highlighted since the addition of a Grade 3 Well Differentiated NET into the equation.The variable clinical outcome of patients with G2 & G3 well diff Gastroenteropancreatic Neuroendocrine Tumours (GEP NETs) makes the selection of…

15Apr 2021 by Ronny Allan No Comments

A Diagnostic Imaging Study of 64Cu-SARTATE™ for Neuroendocrine Tumours

Clinical Trials

Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email We probably should start to use the term "Somatostatin Receptor PET" (SSTR PET) a bit more. We got used to using the term Ga68 PET but since then we have an approved copper version known as 64Cu Dotatate (commercial brand name in US DETECTNET™). Now we have another in the clinical trial pipeline and will add others as they come onto my radar.Ga68 Dotatate/TOC/NOC - click hereCu64 Dotatate (DetectNET) - click hereA Diagnostic Imaging Study of 64Cu-SARTATE™ Using Positron Emission Tomography (PET) on Patients With Known or Suspected NETsReference: NCT04438304Trial status: RecruitingThe purpose of this study is to assess the performance of imaging agent 64Cu-SARTATE in participants with known or suspected Gastroenteropancreatic…

17Jan 2021 by Ronny Allan No Comments

Lanreotide and Keytruda – the PLANET study (NCT03043664)

Clinical Trials

Headline: Roughly 40% of patients with advanced, progressive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with pembrolizumab (Keytruda) in combination with lanreotide (Somulatine Depot) achieved stable disease, according to results from the phase 1b/2 PLANET clinical trial presented during the 2021 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancer Symposium.I've written about Pembrolizumab (Keytruda) before in my general immunotherapy coverage - click here. I did note they weren't really having much luck with Neuroendocrine Neoplasms although I do see some success (.... but not enough) in poorly differentiated carcinomas. Well differentiated NETs remain an immunological desert. However, this poster abstract from ASCO GI conference caught my eye.“Pembrolizumab has antitumor activity in a subset of GEP-NETs patients,” wrote the investigators. “We hypothesized that the lanreotide, by its antitumor effects and reduction of serotonin,…

23Dec 2020 by Ronny Allan 2 Comments

Genome methylation accurately predicts neuroendocrine tumor origin – finding Neuroendocrine Neoplasms of unknown primary

Clinical Trials, Patient Advocacy

It's estimated that around 5-10% of Neuroendocrine Neoplasms (NENs) have an unknown primary - what that means is cancer cells have been found in the body but the place cancer began remains unknown. I wrote about this issue in more depth in my article "Needle in a haystack" - you can read that here. In that article, you will note that NET specialists through their knowledge and understanding of the behaviour of these comped tumours, can often drill down and gather various pieces of evidence to help narrow down the primary location. However, this new study would indicate they could have access to a new tool to be able to home in on a particular location.DNA methylation-based profiling is now routinely used in the diagnostic workup of brain tumors but…

21Dec 2020 by Ronny Allan 2 Comments

Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors – PRRT vs Everolimus

Clinical Trials

When I see a trial for Gastroenteropancreatic NETs (GEPNETs), I know that BP (Bronchopulmonary) NETs (includes Lung) are not included. When you look at the approval wording for the major treatments in use (PRRT Lutathera, Lanreotide), they appear to use the term GEPNETs making BP NETs the poor relative. Clearly there's highly complex reasons why NETs react differently in different parts of the body. I can see that BP NET patients were involved in clinical trials for both of the mainstream treatments listed above. The drug approval process is also highly complex, and I can see from the wording that functional BP NETs with carcinoid syndrome can qualify at least for somatostatin analogues (Lanreotide and Octreotide). That is not to say BP NET patients cannot get access to these treatments,…