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Neuroendocrine Tumors clinical trials

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NCT ID: NCT03412877 Recruiting - Breast Cancer Clinical Trials

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer

Start date: September 6, 2018
Phase: Phase 2
Study type: Interventional

Background: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person. Objective: To see if gene transfer therapy of white blood cells can shrink tumors. Eligibility: People with certain metastatic cancer for which standard treatments have not worked. Design: Participants may complete screening under another protocol. Screening includes: - Getting tumor cells from a previous procedure - Medical history - Physical exam - Scans - Blood, urine, heart, and lung tests The study has 8 stages: 1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. 2. Care at home over approximately 12 weeks. 3. Stopping therapy for 4-6 weeks while their cells are changed in a lab. 4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs. 5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart. 6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer. 7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests. 8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined.

NCT ID: NCT03372356 Recruiting - Clinical trials for Neuroendocrine Tumors

Psychosocial Screening for Neuroendocrine Tumor Patients

Start date: August 9, 2017
Phase: N/A
Study type: Observational

This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.

NCT ID: NCT03308682 Recruiting - Clinical trials for Neuroendocrine Tumors

177Lu-DOTA-EB-TATE in Patients With Advanced Neuroendocrine Tumors

Start date: April 30, 2017
Phase: Phase 1
Study type: Interventional

This is an open-label, non-controlled, non-randomized study to investigate the long-lasting radiolabeled somatostatin analogue based peptide receptor radionuclide therapy and evaluation safety and dosimetry of 177Lu-DOTA-EB-TATE in patients with advanced metastatic neuroendocrine tumors. A single dose of 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE will be injected intravenously. and monitored at 2, 24, 72,120 and 168 hours post-injection with semiquantitative method based on quantitative single-photon emission computed tomography/computed tomography (SPECT/CT) performance.

NCT ID: NCT03288597 Recruiting - Clinical trials for Neuroendocrine Tumors

Explore the Clinical Value of 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in Neuroendocrine Neoplasms

Start date: September 1, 2017
Phase: N/A
Study type: Observational [Patient Registry]

68Ga-DOTANOC and 18F-FDG PET/CT have important values in the staging and clinical treatment of neuroendocrine tumors. Retrospective studies suggest that the positivite rates and SUVmax of dual imaging associated with pathological findings and prognosis. The study was designed to confirm thet clinical values of dual imagings for neuroendocrine tumors.

NCT ID: NCT03279601 Recruiting - Clinical trials for Neuroendocrine Tumors

Study to Compare Capecitabine Combined With Dacarbazine(CAPDTIC) Versus Capecitabine Combined Temozolomide(CAPTEM) in Advanced and Metastatic Gastrointestinal Pancreatic and Esophageal Neuroendocrine Tumor

Start date: September 1, 2017
Phase: Phase 2
Study type: Interventional

The study will be conducted to compare the safety and efficacy of Capecitabine Combined With Dacarbazine(CAPDTIC) and Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.In this prospective randomized phase II study, the investigators aim to compare the survival benefit as well as the safety forCapecitabine Combined With Dacarbazine(CAPDTIC) versus Capecitabine Combined Temozolomide(CAPTEM) in advanced or metastatic gastrointestinal pancreatic and esophageal neuroendocrine tumor.

NCT ID: NCT03206060 Recruiting - Clinical trials for Neuroendocrine Tumors

Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma

Start date: October 10, 2017
Phase: Phase 2
Study type: Interventional

Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.

NCT ID: NCT03204032 Recruiting - Clinical trials for Extrapancreatic Neuroendocrine Tumor

A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Extrapancreatic Neuroendocrine Tumor

Start date: October 2016
Phase: Phase 2
Study type: Interventional

A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and Thalidomide in subjects with Advanced Extrapancreatic Neuroendocrine Tumor

NCT ID: NCT03204019 Recruiting - Clinical trials for Pancreatic Neuroendocrine Tumor

A Study of Tegafur Combined With Temozolomide Versus Tegafur Combined With Temozolomide and Thalidomide in Subjects With Advanced Pancreatic Neuroendocrine Tumor

Start date: October 2016
Phase: Phase 2
Study type: Interventional

A Phase II Randomized,Controlled,Open Label,Multicentre Study to evaluate the efficacy and safety of Tegafur combined with Temozolomide versus Tegafur combined with Temozolomide and Thalidomide in subjects with Advanced Pancreatic Neuroendocrine Tumor

NCT ID: NCT03145857 Recruiting - Clinical trials for Neuroendocrine Tumors

A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use

Start date: March 5, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A [68]Ga-HA-DOTATATE PET/CT or PET/MRI scan is a nuclear medicine test used to create pictures of the whole body that will show where somatostatin receptors are found, including on tumours. Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types of tumours. Currently at the Cross Cancer Institute, most patients with suspected somatostatin positive tumours (e.g. NETs) have an In-111 Octreotide (Octreoscan™) scan. A scientific study has shown that a scan with a similar product ([68]Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at [68]Ga-HA-DOTATATE, a product virtually identical to [68]Ga-DOTATATE. The purpose of this study is to: 1) demonstrate the safety of [68]Ga-HA-DOTATATE; and 2) confirm that [68]Ga-HA-DOTATATE PET/CT or PET/MRI is effective at diagnosing somatostatin positive tumours.

NCT ID: NCT03130205 Recruiting - Clinical trials for Neuroendocrine Tumors

Biomarker Study in Pancreatic Neuroendocrine Tumours

PROGRESS
Start date: May 1, 2017
Phase: N/A
Study type: Observational

The biology of pancreatic neuroendocrine tumors can change during the disease course. This evolution of disease can manifest through increases in tumor proliferation rate, resistance to medical therapy and/or a change in tumor hormone secretion. This study aims to characterize how the biology of pancreatic neuroendocrine tumors change over time, measured by; patient symptoms, biochemistry, contrast enhanced computed tomography, FDG-PET and core needle biopsy with histopathological analysis (Ki67 index and tumor cell differentiation). Uptake on 18F-FDG-PET will be correlated directly to tumor cell proliferation rate. Fraction of patients with spatial heterogeneity in FDG uptake as well as metachronous changes in all collected data will be documented. Biomaterial from whole blood and core needle biopsies will be characterized on the molecular level, and those findings will be integrated to the above specified clinical parameters.