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Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC) << Back Tissue Procurement and Natural History Study of Neuroendocrine Neoplasms (NENs) Including Adrenocortical Carcinoma (ACC) CLINICALTRIALS.GOV IDENTIFIER: NCT05237934 PHASE: Observational STATUS: Recruiting* Dr. Jaydira Del Rivero Discusses Natural History Tissue Study: (NENs) and (ACC) Neuroendocrine neoplasm (NENs)are rare cancers arising from the neuroendocrine cells and can affect almost any part of the body. They vary from low grade neuroendocrine tumors (NETs) to high grade neuroendocrine carcinomas (NECs). These tumors often occur in the gastrointestinal tract, pancreas, lungs, adrenal medulla (pheochromocytomas) or adrenal cortex (adrenocortical cancer) and other areas of the body mentioned below: Gastroenteropancreatic neuroendocrine tumors (GEP-NET): stomach, duodenum, pancreas, colon, appendix, etc. Liver and gallbladder Adrenal tumors Pituitary gland Thyroid gland: medullary thyroid carcinoma Parathyroid tumors Pulmonary neuroendocrine tumors: typical and atypical carcinoid, small cell lung cancer (SCLC), large cell neuroendocrine carcinoma (LCNEC) Extrapulmonary small cell cancer Peripheral nervous system tumors: paraganglioma, neuroblastoma) Breast and genitourinary tract Their rates are rising in the United States and worldwide. Researchers want to learn more about NENs through this natural history study. OBJECTIVE: To study the natural history of people with NENs and obtain samples from them to learn more about the disease. The clinical management of all NETs is not standardized, with only a few FDA-approved therapies and we would like to learn which combination therapeutic approach should be used, how long treatment should be continued, and in what subgroup of NENs a particular treatment option should be used. ELIGIBILITY: People aged 18 and older who have or are suspected to have NENs or ACC. According to Dr. Del Rivero, this study will “give patients hope for new treatment options. Information from the study will be shared broadly with physicians. The goal of the study is to have a greater understanding of how NENs behave so we can develop new treatments that both improve patients’ quality of life and extend their lives.” For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. *NCI reimburses travel and lodging. Download reimbursement information in English. NCI Travel and Lodging Reimbursement Handout for Patients _9.23.2022 .pdf Download PDF • 121KB Download reimbursement information in Spanish. NIH-22-480 #7174 NCI Travel and Lodging Reimbursement Handout for Patients _9232022_Spanis .pdf Download PDF • 143KB CONTACTS: Jaydira Del Rivero, MD EMAIL: jaydira.delrivero@nih.gov

Lu-177 DOTATATE vs Everolimus in Lung NETs << Back Randomized Phase II Trial of Lutetium Lu-177 Dotatate Versus Everolimus in Somatostatin Receptor Positive Bronchial Neuroendocrine Tumors DRUG/TREATMENT: LUTETIUM LU-177 DOTATATE (PRRT) + (EVEROLIMUS) CLINICALTRIALS.GOV IDENTIFIER: NCT04665739 PHASE: 2 STATUS: Recruiting SPONSOR: National Cancer Institute (NCI) Dr. Suki Padda Discusses Lu177 Dotatate in Lung NETs Dr. Heloisa Soares Discusses Lu-177 Dotatate in Lung NETs DESCRIPTION: This phase II trial studies the effect of lutetium Lu-177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu-177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu-177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors. For more information on eligibility criteria, trial locations, study details, etc. go to ClinicalTrials.gov to view this trial here. PRINCIPAL INVESTIGATORS: Thomas A. Hope, MD, UCSF Sukhmani K. Padda, MD, Cedars Sinai Medical Center, Los Angeles, California CONTACT: This is a multicenter trial with various locations. Go to the “Contacts and Locations” section of this trial page at ClinicalTrials.gov for site-specific contact information.

CHM-2101 CAR-T cell for GI Cancers << Back A Phase 1 / 2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy IDENTIFIER ( ClinicalTrials.gov ) : NCT06055439 DRUG/TREATMENT : CHM-2101 CAR-T Cells PHASE : 1/2 STATUS : Recruiting SPONSOR : Chimeric Therapeutics DESCRIPTION: Chimeric Therapeutics is sponsoring a Phase 1/2 open-label study to evaluate CHM-2101, an autologous CDH17 CAR T-cell therapy for the treatment of advanced G1, G2, and well-differentiated G3 neuroendocrine tumors of the midgut and hindgut (ileal, jejunal, cecal, distal colonic, or rectal; with ≤ 55% Ki67 expression) that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting. Phase 1 involves dose escalation and expansion. The recommended Phase 2 dose will be based on results from the Phase 1. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT: Jason B. Litten, MD EMAIL: jlitten@chimerictherapeutics.com PHONE: 415-802-4360 RELATED RESOURCES Chimeric Therapeutics Announces FDA Clearance of IND Application for CHM 2101, A Novel CDH17 CAR T Cell Therapy for Advanced Gastrointestinal Cancers

Paltusotine in Carcinoid Syndrome << Back Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome CLINICALTRIALS.GOV IDENTIFIER: NCT05361668 DRUG/TREATMENT: Paltusotine PHASE: 2 STATUS: Recruiting SPONSOR: Crinetics Pharmaceuticals Inc. Update from the 2025 ENETS Annual Medical and Scientific Conference in Krakow, Poland (March 5-7, 2025): Paltusotine_ENETS 2025 .pdf Download PDF • 356KB Dr. Aman Chauhan Discusses Paltusotine in Carcinoid Syndrome UPDATE: On Tuesday, March 12, 2 024, Crinetics Pharmaceuticals announced positive topline results from their Phase 2 study of Paltusotine, a once-daily pill, under investigation for the treatment of carcinoid syndrome. The results show that Paltusotine was generally well-tolerated and reduced the frequency and severity of bowel movements and flushing. The company plans to engage the FDA to initiate a P hase 3 trial by the end of 2024. To read the announcement, go to the March 12, 2024 press release . To view the live webcast discussing the data and slides, go to the Paltusotine Study Results Presentation . UPDATE: On Monday, December 18, 2023, Crinetics announced positive initial findings from their ongoing open-label phase 2 study of paltusotine for the treatment of carcinoid syndrome. Today's announcement states “These initial results show the potential of paltusotine to significantly reduce both frequency and intensity of bowel movements and flushing, the key carcinoid syndrome symptoms. Further, paltusotine was well-tolerated and the overall pharmacokinetic profile was consistent with prior studies. After completing this Phase 2 study next quarter, we anticipate sharing the results with the FDA to align on the design of a Phase 3 program.” To read the announcement, go to the December 18, 2023 press release . To view the slides from the announcement, go to the, " CRINETICS INITIAL FINDINGS FROM ONGOING OPEN-LABEL PHASE 2 STUDY OF PALTUSOTINE FOR THE TREATMENT OF CARCINOID SYNDROME " . UPDATE: On Sept 10, 2023, Crinetics Pharmaceuticals announced positive results for their paltusotine phase 3 acromegaly study. This is the same once-daily pill that is currently in a phase 2 study for NET patients with carcinoid syndrome. To read the announcement, go to https://crinetics.com/crinetics-paltusotine-achieved-primary-and-secondary-endpoints-in-phase-3-pathfndr-1-acromegaly-study/ . DESCRIPTION: Crinetics is sponsoring a phase 2 study to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT: Crinetics Clinical Trials EMAIL: clinicaltrials@crinetics.com PHONE: 833-827-9741

LAMPARA: LAnreotide in Metastatic Pheochromocytoma/PARAganglioma << Back LAMPARA: LAnreotide in Metastatic Pheochromocytoma and PARAganglioma CLINICALTRIALS.GOV IDENTIFIER: NCT03946527 DRUG/TREATMENT: Lanreotide PHASE: 2 STATUS: Recruiting SPONSOR: Antonio Fojo, Columbia University COLLABORATOR: Ipsen Dr. Jaydira Del Rivero Discusses LAMPARA DESCRIPTION: The objectives of this study are: To assess the efficacy of lanreotide given every 4 weeks in participants with advanced or metastatic paraganglioma/ pheochromocytoma. To assess the toxicity and safety of lanreotide in participants with advanced or metastatic paraganglioma/ pheochromocytoma. To document the effects of lanreotide on markers of biochemical activity in participants with advanced or metastatic paraganglioma/ pheochromocytoma. Primary endpoints: Assess efficacy by estimating the tumor growth rate while a patient is enrolled on study and comparing the growth rates on lanreotide to the pre-enrolment growth rate. Secondary endpoints include measurement of: Overall survival (OS) Progression-free survival (PFS) Overall response rate (ORR) according to RECIST defined as partial response (PR) + complete response (CR) Magnitude of reduction in levels of 24-hour urinary metanephrines, catecholamines and magnitude of reduction in serum chromogranin A, evaluated every two months while enrolled on study. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here . CONTACT/Principal Investigator: Antonio Fojo, MD, PhD, Columbia University EMAIL: atf2116@cumc.columbia.edu PHONE: 212-305-9422 Research Nurse Navigator EMAIL: cancerclinicaltrials@cumc.columbia.edu PHONE: 212-342-5162

NETTER-P: Lutathera in Adolescent Patients (12-17) with GEP-NETs and PPGLs << Back NETTER-P: Study to Evaluate Safety and Dosimetry of Lutathera in Adolescent Patients With GEP-NETs and PPGLs CLINICALTRIALS.GOV IDENTIFIER: NCT04711135 DRUG/TREATMENT: Lutetium [177Lu] oxodotreotide/dotatate PHASE: 1 STATUS: Recruiting SPONSOR: Advanced Accelerator Applications (AAA) UPDATE: Lutathera PRRT now approved for adolescents (12-17 year olds) On April 23, 2024, the Food and Drug Administration approved lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications USA, Inc., a Novartis company) for pediatric patients 12 years and older with somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. Lutetium Lu 177 dotatate received approval for this indication for adults in 2018. This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs. Full prescribing information for Lutathera will be posted here . Read the complete FDA announcement here . Read the Novartis press release here . Dr. Aman Chauhan Discusses "NETTER-P" Lutathera in Adolescent Patients DESCRIPTION: Advanced Accelerator Applications (AAA) is sponsoring a multicenter, open-label, single-arm study to evaluate the safety and dosimetry of Lutathera in adolescent patients 12 to <18 years old with somatostatin receptor positive GEP-NETs and PPGLs. The study will enroll at least 8 patients in the GEP-NET cohort and as many adolescents with PPGL as possible in the exploratory PPGL cohort. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT: Novartis Pharmaceuticals EMAIL: Novartis.email@novartis.com PHONE: 1-888-669-6682

CDK4/6 Abemaciclib GEP-NETS << Back Abemaciclib in Treating Patients With Advanced, Refractory, and Unresectable Digestive System Neuroendocrine Tumors CLINICALTRIALS.GOV IDENTIFIER: NCT03891784 DRUG/TREATMENT: abemaciclib PHASE: 2 STATUS: Recruiting SPONSOR: University of Washington Collaborator: Eli Lilly and Company Dr. Heloisa Soares Discusses CDK4/6 abemaciclib GEP-NETS DESCRIPTION: This phase II trial studies how well abemaciclib works in treating patients with digestive system neuroendocrine tumors that have spread to other places in the body, do not respond to treatment, and cannot be removed by surgery. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT/Principal Investigator: David B. Zhen, MD Fred Hutch/University of Washington Cancer Consortium EMAIL : dbzhen@uw.edu

SWOG S2012: Immunotherapy (Atezolizumab) + Standard Platinum Chemotherapy for NEC << Back SWOG S2012 - Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung CLINICALTRIALS.GOV IDENTIFIER: NCT05058651 DRUG/TREATMENT: Atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) PHASE: II/III STATUS: Recruiting SPONSOR: National Cancer Institute (NCI) Dr. David Zhen Discusses SWOG S2012 Immunotherapy (atezolizumab) DESCRIPTION: This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here . CONTACT: This is a multicenter trial with various locations. Go to the “Contacts and Locations” section of this trial page at ClinicalTrials.gov for site-specific contact information. Principal Investigator: David B. Zhen, MD Southwest Oncology Group

Lu-177 DOTATATE + Olaparib in GEP-NETs << Back Lu-177-DOTATATE in Combination With Olaparib in Inoperable Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) CLINICALTRIALS.GOV IDENTIFIER: NCT04086485 DRUG/TREATMENT: Lu-177 DOTATATE + OLAPARIB PHASE I / II STATUS: Recruiting SPONSOR: National Cancer Institute (NCI) Dr. Del Rivero discusses Lu177-Dotatate + OLAPARIB DESCRIPTION: This phase 1-2 trial tests Lu-177-DOTATATE (Lutathera) in combination With olaparib (PARP inhibitor) in inoperable gastroenteropancreatic Neuroendocrine Tumors (GEP-NET). The objective is to learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lu-177 DOTATATE and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. PRINCIPAL INVESTIGATOR: Frank Lin, MD CONTACT: National Cancer Institute Joy Zou, RN EMAIL: joy.zou@nih.gov PHONE: 240-760-6153

Alpha PRRT with Pb-212 VMT << Back Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (212-Pb-VMT) IDENTIFIER ( ClinicalTrials.gov ) : NCT05636618 DRUG/TREATMENT : Alpha PRRT with 212Pb VMT PHASE : 1 / 2A STATUS : Recruiting SPONSOR : Perspective Therapeutics DESCRIPTION: June 2024: Dr. Aman Chauhan discusses the Alpha PRRT with Pb-212 VMT study. Perspective Therapeutics is sponsoring a phase 1 / 2A prospective, multi-center open-label dose escalation, dose expansion study of [212Pb]VMT01 in up to 52 adult subjects with unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs) who have not received prior peptide receptor radionuclide therapy (PRRT). During phase 1, there is a dose escalation period testing up to 4 escalating radioactivity dose cohorts of up to 8 subjects (administered at approximately 8-week intervals) at the assigned cohort radioactivity dose. Phase 1 studies the side effects, safety, and dosimetry. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT : Markus Puhlmann, MD, MBA at Perspective Therapeutics EMAIL: mpuhlmann@perspectivetherapeutics.com PHONE: (319) 665-2150

DAREON™-9: DLL-3 BiTE + Topotecan in Small Cell Lung Cancer (SCLC) << Back ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us.

Lu-177 DOTATATE + Triapine in GEP-NETs << Back Phase 2 Trial: Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors DRUG/TREATMENT: LUTATHERA (Lu-177) + Triapine CLINICALTRIALS.GOV IDENTIFIER: NCT05724108 PHASE: 2 STATUS: Recruiting SPONSOR: National Cancer Institute (NCI) June 2024: Dr. Aman Chauhan discusses Phase 2 LUTATHERA (Lu-177) + Triapine study April 2023: Dr. Aman Chauhan discusses Phase 2 LUTATHERA (Lu-177) + Triapine study DESCRIPTION: This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT/Principal Investigator: Aman Chauhan, MD EMAIL: axc3268@med.miami.edu RELATED RESOURCES Clinical Trials Using Lutetium Lu 177 Dotatate - NCI Dr. Chauhan's presentation slides can be downloaded here: Dr. Chauhan Presentation on Lu-177 DOTATATE + Triapine Trial .pptx Download PPTX • 16.18MB 2023 NANETS Abstract shows the combination of Triapine and Lu-177 DOTATATE was safe with preliminary efficacy signals.