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

Completed · Phase 2

Conditions studied: Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer. Interferon alfa may interfere with the growth of tumor cells. Oblimersen may increase the effectiveness of interferon alfa by making tumor cells more sensitive to the drug.

Key facts

Study ID

NCT00059813

Run by

National Cancer Institute (NCI)

People needed

41

Starts

2003-08-01

Last updated by the study team

2013-08-26

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• City of Hope — Duarte, California, United States

Full record on ClinicalTrials.gov

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