RAD001 and Temozolomide in Patients With Advanced Pancreatic Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2019-03-29
• Target enrollment: 0
• Participant gender: All

Summary

This research study will test the safety of RAD001 in combination with temozolomide.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital; Novartis; Schering-Plough
• Treatments: Dacarbazine; Everolimus; Sirolimus; Temozolomide

Criteria

Inclusion Criteria:

• Locally unresectable or metastatic pancreatic neuroendocrine tumor

• Radiologic, operative, or pathology reports should document a pancreatic location of tumor

• Patients must have confirmed low-grade or intermediate-grade neuroendocrine carcinoma

• Patients must have at least one measurable site of disease according to RECIST criteria that has not been preciously irradiated

• 18 years of age or older

• Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy

• Prior treatment with chemotherapy is allowed, with the exception of prior treatment with temozolomide or dacarbazine

• No Prior therapy with RAD001 or any other mTOR inhibitor

• ECOG Performance status 0,1 or 2

• Life expectancy 12 weeks or more

• Adequate bone marrow, liver and renal function as outlined in the protocol

• Negative serum pregnancy test

• Fasting serum cholesterol as outlined in protocol

Exclusion Criteria:

• Prior treatment with any investigational drug within the preceding 4 weeks

• Chronic treatment with systemic steroids or another immunosuppressive agent

• Patients should not receive immunization with attenuated live vaccines during study period or within 1 week of study entry

• Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases

• Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinoma of the skin

• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study

• Women who are pregnant or breast feeding

• Patients who have received prior treatment with an mTOR inhibitor or temozolomide

• Patients with known hypersensitivity to RAD001 or other rapamycins or to its excipients

• History of noncompliance to medical regimens