Clinical Trial Information

Protocol – Alliance – A021804

SCHEMA A021804

Please Note – Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

1. Histologically-proven advanced (metastatic or unresectable primary) pheochromocytoma or paraganglioma.
2. Advanced (metastatic or unresectable primary) disease. Histologically-proven pheochromocytoma or paraganglioma and  radiographic evidence of disease progression by RECIST v1.1 criteria in the 12 months prior to registration.
3. Measurable disease.
4. Prior treatment with other chemotherapy, radiotherapy (including peptide radionuclide receptor therapy [PRRT]), or surgery must be completed ≥ 28 days prior to registration. Patients must have recovered from any effects of any major surgery prior to registration.
   Prior treatment with radiolabeled MIBG must be completed ≥ 12 weeks prior to registration and lifetime cumulative 131I-MIBG dose must be < 1000 MBq kg-1 (36 mCi kg-1).
   Prior treatment with antibiotics must be completed ≥ 7 days prior to registration.
   No prior treatment with temozolomide, dacarbazine, or a poly ADP ribose polymerase (PARP) inhibitor.
   No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
5. Age ≥ 18 years.
6. ECOG Performance Status: 0-2.
7. Concurrent use of combination antiretroviral therapy (ART) is not permitted.
   Chronic concomitant treatment with strong or moderate CYP3A4 inducers or inhibitors is not allowed. Patients must discontinue the agent(s) ≥ 21 days prior to registration; enzalutamide and/or phenobarbital must be discontinued ≥ 5 weeks prior to registration.

Clinical Trial Information

Protocol: Alliance – A021602

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

1. Well- or moderately-differentiated neuroendocrine tumors of pancreatic and non-pancreatic (i.e. carcinoid) origin by local pathology. The pathology report must state ONE of the following: 1) well- or moderatelydifferentiated
   neuroendocrine tumor, 2) low- or intermediate-grade neuroendocrine tumor, or 3) carcinoid tumor or atypical carcinoid tumor.
   Documentation of histology from a primary or metastatic site is allowed. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible.
2. Locally advanced/unresectable or metastatic disease.
3. Histological documentation of neuroendocrine tumor of pancreatic, gastrointestinal (GI), lung, or unknown primary site. GI, lung, and unknown primary NETs will enroll in the carcinoid tumor cohort of the study. Functional (associated with a clinical hormone syndrome) or nonfunctional tumors.
   are allowed.
4. Target lesions must have shown evidence of disease progression by RECIST v1.1 criteria in the 12 months prior to registration. The
   radiologic images, imaging reports, and clinic notes indicating growth of existing lesions, development of new lesions, or treatment changes must be submitted per Section 6.1.1.
5. Patients must have measurable disease. Lesions must be accurately measured in at least one dimension (longest diameter to be
   recorded) as ≥ 1 cm with CT or MRI (or ≥ 1.5 cm for lymph nodes). Non-measurable disease includes disease smaller than these dimensions or lesions considered truly nonmeasurable including: leptomeningeal disease, ascites, pleural or pericardial effusion,
   lymphangitic involvement of skin or lung. See Section 11.0 for additional details.
6. Patient must have failed at least one prior systemic therapy that included everolimus. Disease progression or treatment intolerance leading to discontinuation is considered treatment failure. Prior treatment (except somatostatin analogs) with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, and/or radiation must be completed at least 28 days prior to registration.
7. No “currently active” second malignancy other than non-melanoma skin cancers or cervical carcinoma in situ. Patients are not considered to have a “currently active” malignancy if they have completed therapy and are free of disease for ≥ 3 years.
8. Other planned concurrent investigational agents or other tumor directed therapies (chemotherapy, radiation) are not allowed while on this study.
9. Age ≥ 18 years.
10. ECOG Performance Status: 0-2.

Clinical Trial Information

PROTOCOL: ECOG-EA2142

SCHEMA EA2142

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Patients must have a locally advanced and unresectable or metastatic gastroenteropancreatic neuroendocrine carcinoma that is either
   known or suspected to be of GI origin. Primary tumors arising from the lung, gynecologic organs or prostate are not permitted.
2. Patients must have pathologically/histologically confirmed tumor of non-small cell histology.
3. Patients must have a Ki-67 proliferative index of 20-100% OR at least 10 mitotic figures per 10 high powered fields.
4. Patients must have measurable disease/
5. Patients may not have had any prior systemic therapy (chemotherapy, targeted therapy, PRRT) for this malignancy. Prior somatostatin
   therapy is permitted. Prior palliative radiation is permitted but radiated lesions may not be used for measurement.
6. Patients may not have received any of the protocol agents within 5 years prior to randomization.
7. Patients must be at least ≥ 18 years of age.
8. Patients must have an ECOG performance status of 0-2.
9. Patients may not be receiving any other investigational agents while on study treatment.
10. Patients may not be receiving Coumadin while on treatment. Other anticoagulants are allowed.
11. Patients must have a life expectancy of ≥ 12 weeks as determined clinically by the treating physician.
12. Patients with brain metastases (either remote or current) or presence of carcinomatous meningitis are not eligible.