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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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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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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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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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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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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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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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Study of Efficacy and Safety of PDR001 in Patients With Advanced or Metastatic, Well-differentiated, Non-functional Neuroendocrine Tumors of Pancreatic, Gastrointestinal (GI), or Thoracic Origin or Poorly-differentiated Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC)
Rochester, MN
This is a study to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that have progressed on prior treatment.
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A Study to Evaluate CHIP and Hematological Toxicity After PRRT in Neuroendocrine Tumor Patients
Scottsdale/Phoenix, AZ; Rochester, MN; Jacksonville, FL
The purpose of this study is to combine robust clinical data (e.g., prior chemotherapy or radiation exposure, cumulative Peptide Receptor Radionuclide Therapy (PRRT dose)) with genetic and clonal abnormalities (blood-based CHIP panel) in studying the predisposing risk factors for developing hematological toxicity including t-MN in PRRT-treated neuroendocrine tumor (NET) patients.
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Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Jacksonville, FL; Rochester, MN; Scottsdale/Phoenix, AZ
The purpose of this study is to see how well cabozantinib S-malate works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
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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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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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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 Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Rochester, MN
The purpose of this trial is to study 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.
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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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Comparing Capecitabine and Temozolomide in Combination to Lutetium Lu 177 Dotatate in Patients With Advanced Pancreatic Neuroendocrine Tumors
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
The purpose of this study is to compare capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose ...
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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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EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
Rochester, MN; Scottsdale/Phoenix, AZ; Jacksonville, FL
Advanced Accelerator Applications is currently pursuing marketing approval for 177Lu-DOTA0-Tyr3-Octreotate (Lutathera). This expanded access therapeutic protocol aims to allow patients suffering from inoperable, somatostatin receptor positive, neuroendocrine tumors, progressive under somatostatin analogue therapy to access the investigational product, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera), prior to its commercial availability.
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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 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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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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Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery
Rochester, MN; Scottsdale/Phoenix, AZ; Rochester, MN
This phase II trial studies how well sapanisertib works in treating patients with pancreatic neuroendocrine tumor that has spread to other places in the body, does not respond to treatment, or cannot be surgically removed. Drugs such as sapanisertib may stop the growth or shrink tumor cells by blocking some of the enzymes needed for cell growth
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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 of XmAb ®18087 in Subjects With NET and GIST
Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN
The purpose of this study is to determine the safety and tolerability profile of XmAb18087 in subjects with advanced, well-differentiated neuroendocrine tumors (NET) of pancreatic, gastrointestinal, lung, and undetermined origin, and subjects with advanced gastrointestinal stromal tumors (GIST), and to identify the maximum tolerated dose (MTD) and/or recommended dose (RD) and schedule of XmAb18087 administered by intravenous (IV) dosing on Days 1, 8, 15, and 22 of each 28-day cycle in subjects with advanced NET and advanced GIST, separately.
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A Study to Determine Safety, Pharmacokinetics and Pharmacodynamics of Intravenous TKM 080301 in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
Scottsdale/Phoenix, AZ; Rochester, MN
This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.
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A Study to Test the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) with One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Eau Claire, WI; Scottsdale/Phoenix, AZ; Rochester, MN
The purpose of this study is to assess how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no ...
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A Study of INCMGA00012 in Metastatic Merkel Cell Carcinoma
Rochester, MN
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with metastatic merkel cell carcinoma (MCC).
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Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors
Rochester, MN
The purpose of this study is to find out more about the side effects of rovalpituzumab tesirine (SC16LD6.5) and what doses of rovalpituzumab tesirine (SC16LD6.5) are safe for people with specific delta-like protein 3-expressing cancers.
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Understanding the Challenges, Behavioral Patterns, and Preferences Towards Participation in Clinical Trials in Minority Patient Populations
Jacksonville, FL; Scottsdale/Phoenix, AZ; 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.
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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.