Oblimersen and Interferon Alfa in Treating Patients With Metastatic Renal Cell Cancer

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