RAD001 in Advanced Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Laboratory studies have shown that RAD001 can prevent cells from multiplying. Consequently, the study drug is being tested in medical conditions in which excessive cell multiplication (as in cancer) needs to be stopped. The main purpose of this research study is to find the highest dose of RAD001 that can be given safely (without causing severe side effects) and to learn the effects (good or bad) RAD001 has on participants with liver cancer.

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

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Dana-Farber Cancer Institute; Novartis
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Unresectable of metastatic HCC. Patients must have prior core biopsy to confirm the diagnosis of HCC and have archived tissues available for correlative studies

• At least one measurable site of disease according to RECIST criteria that has not been previously irradiated. If it has had previous radiation to teh marker lesion(s), there must be evidence of progression since the radiation

• 0-2 prior systemic chemotherapy and biologic regimens for hepatocellular carcinoma

• Patients with prior chemoembolization history can participate in the study if the chemoembolization was performed more than 4 weeks ago and patients must have measurable disease outside of prior chemoembolization field

• 18 years of age or older

• Minimum of 4 weeks since any major surgery or completion of radiation

• Minimum of 4 weeks since completion of all prior systemic anticancer therapy

• ECOG performance status of 0-2

• CLIP score of equal to or less then 3

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

Exclusion Criteria:

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

• Chronic treatment with systemic steroids or another immunosuppressive agent

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

• Patients with any severe and/or uncontrolled medical conditions or other condition that could affect participation in the study

• Known history of HIV seropositivity

• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001

• Active, bleeding diathesis

• Women who are pregnant or breast feeding

• Patients who have received prior treatment with an mTor inhibitor

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

• History of non-compliance to medical regimens

• Patients with a positive dipstick for urine protein (reading of 2+ or greater) will then undergo a 24-hour urine collection for protein. If patients have a 2g or greater of protein/24hr, they will be excluded from the study.