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Neuroendocrine Tumors - Patient Reported Outcomes
Rochester, MN
The purpose of this study is to partner with patients on comparative effectiveness research (CER) to achieve the goal of alleviating undue toxicity, and optimizing effectiveness and sequencing of therapy for patients with Neuroendocrine Tumors (NET).
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A Study To Evaluate Triapine Combined With Lutetium Lu 177 Dotatate For Gastroenteropancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety and to determine the recommended phase 2 dose (RP2D) of Lutetium Lu 177 Dotatate in combination with triapine.
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Targeted Alpha-Particle Therapy For Advanced SSTR2 Positive Neuroendocrine Tumors
Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary effectiveness of [ 212Pb]VMT-α-NET, an alpha particle radiation delivering agent targeted to somatostatin receptor type 2 (SSTR2).
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Study to Evaluate the Efficacy and Safety of [177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of the current study is to evaluate the efficacy and safety of \[177Lu\]Lu-DOTA-TATE plus octreotide long-acting release (LAR) versus octreotide LAR alone in newly diagnosed patients with somatostatin receptor positive (SSTR+), well differentiated Grade1 and Grade 2 (G1 and G2) (Ki-67 \<10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden advanced="" gastroenteropancreatic="" neuroendocrine="" tumors="" (gep-nets)="" with="" high="" disease="" burden="">10%) advanced gastroenteropancreatic neuroendocrine tumors (gep-nets) with high disease burden >
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A Trial To Assess Effectiveness And Safety Of Octreotide Subcutaneous Depot In Patients With GEP-NET
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated Gastroenteropancreatic-Neuroendocrine Tumors (GEP-NET). Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029.
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A Study Using Octreotide Scan versus PET Scan in the Diagnosis and Follow-up of Patients with Carcinoid and Neuroendocrine Tumors
Scottsdale/Phoenix, AZ
The purpose of this study is to determine if octreotide scans are more sensitive than PET scans for diagnosing carcinoid or neuroendocrine tumors.
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Correlation of Pancreatic Islet Morphology with Postprandial Glucose Tolerance in Subjects Undergoing Pancreatic Resection for Islet Cell Tumors
Rochester, MN
Determine the effect of endocrine pancreas morphology, turnover and dedifferentiation on glucose tolerance in humans.
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Prognostic and Predictive Biomarkers in Neuroendocrine Tumors
Rochester, MN
The purpose of this study is to identify prognostic biomarkers of neuroendocrine carcinomas.
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Care Processes And Person Centered Care Of Patients With Neuroendocrine Tumors
Rochester, MN
Given that neuroendocrine tumors (NETs) represent a rare condition with complex treatment decisions and a lack of concrete guidance for physicians, shared-decision making (SDM) is particularly challenging.In an effort to improve PCC, we hope to identify care processes throughout the clinical encounter that are important to patients. Identifying these processes would allow for standardization of the care environment without focusing on specific provider characteristics. As such, changes to the institutional and system-level processes could be made in more actionable and systematic ways.
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Cisplatin And Etoposide Or Temozolomide And Capecitabine In Treating Patients With Neuroendocrine Carcinoma Of The Gastrointestinal Tract Or Pancreas That Is Metastatic Or Cannot Be Removed By Surgery
Rochester, MN
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current ...
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Study Of [68Ga]FAPI-46 PET In Patients With Pancreatic Ductal Carcinoma
Rochester, MN
The purpose of this study is to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection.
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Utility Of Gallium-68-DOTA-Octreotat PET/CT In The Characterization Of Pediatric Neuroendocrine Tumors
Rochester, MN
The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary
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Comparing Retreatment Of 177Lu-DOTATATE PRRT Versus Everolimus In Patients With Metastatic Unresectable Midgut Neuroendocrine Tumors, NET RETREAT Trial
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is tol compare the effect of retreatment with 177Lu-DOTATATE peptide receptor radionuclide therapy (PRRT) to the usual approach of treatment with everolimus in patients who have previously received 177Lu-DOTATATE for midgut neuroendocrine tumor (NET) that has spread from where it first started (primary site) to other places in the body (metastatic) and that cannot be removed by surgery (unresectable).
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Study Of RYZ101 Compared With SOC In Pts W Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
This study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
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Study To Evaluate The Efficacy And Safety Of Lutathera In Patients With Grade 2 And Grade 3 Advanced GEP-NET
Rochester, MN
The purpose of this study is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression.
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A Study To Evaluate CHIP And Hematological Toxicity After PRRT In Neuroendocrine Tumor Patients
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The overall objective of this project is to combine robust clinical data (e.g. prior chemotherapy or radiation exposure, cumulative radiotheranostic dose) with geneticclonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in radiotheranostic treated solid tumor patients.
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Zanzalintinib Versus Everolimus In Participants With Locally Advanced Or Metastatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
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Study Using Chromogranin A As Surveillance Biomarker In Patients With CARcinoids
Rochester, MN
The purpose of this study is to monitor and validate the performance and stability of the BRAHMS Chromogranin A (CgA) II KRYPTOR Assay in patients with Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs).
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Testing The Use Of Chemotherapy After Surgery For High-Risk Pancreatic Neuroendocrine Tumors
Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to evaluate the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
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Carcinoid Syndrome Efficacy Study Featuring An Oral Daily Paltusotine Regimen
Rochester, MN
The purpose of this study is to assess the efficacy of paltusotine vs placebo in reducing flushing episodes.
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Evaluating The Addition Of The Immunotherapy Drug Atezolizumab To Standard Chemotherapy Treatment For Advanced Or Metastatic Neuroendocrine Carcinomas That Originate Outside The Lung
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to compare 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).
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Lutetium 177Lu-Edotreotide Versus Best Standard Of Care In Well-differentiated Aggressive Grade-2 And Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)
Rochester, MN
The purpose of the study is to evaluate the effectiveness, safety and patient-reported outcomes of peptide receptor radionuclide therapy (PRRT) with 177Lu-Edotreotide as 1st or 2nd line of treatment compared to best standard of care in patients with well-differentiated aggressive grade 2 and grade 3, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin.
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A Registry of Biospecimens at Mayo Clinic to Support Translational Research into the Biology, Etiology and Prognosis of Neuroendocrine Tumors
Jacksonville, FL
The purpose of this registry at Mayo Clinic Jacksonville, is to keep a database and biospecimens of all patients treated surgically and non-surgically for a gastro-enteropancreatic mass or a suspected metastatic lesion from a gastro-entero-pancreatic primary. This registry will keep demographic, clinical and pathologic data on each patient as well as follow-up information on outcome endpoints such as death and recurrence of disease, blood cell samples, and tissue samples from surgically removed tumors.
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A Study Of AMG 757 In Participants With Neuroendocrine Prostate Cancer
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the safety and tolerability of AMG 757, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).
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A Study Evaluating Temozolomide Vs. Temozolomide And Olaparib For Advanced Pheochromocytoma And Paraganglioma
Rochester, MN
The purpose of this study is to determine how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping ...
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Temsirolimus and Bevacizumab in Treating Patients with Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer
Rochester, MN; Jacksonville, FL; Scottsdale/Phoenix, AZ
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may ...
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A Survey of Pheochromocytoma and Paraganglioma Patient Environment
Rochester, MN
The purpose of this study is to determine the association of environmental, geographic factors, as well as presence of comorbidities associated with hypoxia with development of pheochromocytomas and paragangliomas (PPGL), location of PPGL, and number of PPGL.
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A Study To Compare Somatostatin Analogues With Perioperative Antibiotics Versus Prolonged Antibiotics
Rochester, MN
The purpose of this study is to to determine the individual treatment effect of somatostatin and whether duration of antibiotic therapy coupled with octreotide provides improved outcomes after pancreaticoduodenectomy.
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A Study To Evaluate Exercise For Cancer Patients At Risk Of Falling
Rochester, MN
The purpose of this study is to develop a data-driven approach that enables healthcare providers to “prescribe” exercise in the appropriate dose in a manner analogous to prescribing a drug.
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Understanding The Challenges, Behavioral Patterns, And Preferences Towards Participation In Clinical Trials In Minority Patient Populations
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to evaluate the challenges, behavioral patterns, and preferences of minority patient participation in clinical trials. Also, to develop and validate a personalized clinical trial educational platform to boost participation among underserved cancer patients.