Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell Cancer
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer
About this trial
This is an interventional treatment trial for Recurrent Renal Cell Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, measurable metastatic renal cell cancer; if a nephrectomy was performed in the setting of metastatic disease, post-nephrectomy progression of metastases must be documented Performance status 0-2 (SWOG), life expectancy > 3 months Prior radiation must have been completed > 4 weeks before enrollment, with measurable disease outside of the radiation port WBC > 3500/μl Absolute neutrophil count > 1500/μl Platelets > 100,000/μl Transaminases < 2 x institutional upper limit of normal Serum bilirubin < 1.5 x institutional upper limit of normal (if Gilbert's, up to 2 x upper limit) Serum alkaline phosphatase < 2.5 x institutional upper limit of normal Patients with hepatic metastases may have 50% higher levels of all the above-listed parameters Serum creatinine < 1.5 x institutional upper limit of normal Patients with active or recently-treated autoimmune disease are excluded, as are patients currently receiving or expected to require corticosteroid therapy Prior malignancy is limited to adequately treated non-melanoma skin cancer, cervical carcinoma-in-situ, or any other malignancy for which the patient has been disease-free for at least 5 years Because the effects of G3139 on the unborn fetus or newborn infant are unknown, pregnant or lactating women are excluded, and patients with reproductive potential must agree to use a medically-acceptable form of birth control Patients must have fully recovered from the effects of any prior surgery or medical illness such as infection; those with psychosocial problems that might compromise safety or protocol compliance are excluded Central venous access is required Patients may have received up to two prior biological therapy regimens, excluding exposure to either of the therapy agents and patients may have had no more than one prior chemotherapy regimen; full recovery from all toxicities must have occurred; for high-dose IL-2, at least 8 weeks must have elapsed since prior treatment Written, voluntary informed consent Previous chemotherapy must have been completed at least 3 weeks before treatment under this protocol can be initiated Patients with a history of brain metastases, or who are currently being treated, or have untreated brain metastases, are not eligible; Note: if patient received steroid therapy, at least three weeks must have elapsed prior to entry on this protocol Patients must have normal baseline PT/PTT; Note: For those patients taking low dose coumadin (e.g., as prophylaxis for a venous access device) and INR of up to 1.5 is allowed
Sites / Locations
- City of Hope
Arms of the Study
Arm 1
Experimental
Treatment (recombinant interferon alfa, oblimersen sodium)
Patients receive oblimersen IV continuously on days 1-7 and interferon alfa subcutaneously on days 4, 6, 8, 10, and 12 of course 1 and on days 1, 3, 5, 8, 10, and 12 of all subsequent courses. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients achieving a CR receive an additional 2 courses past CR.