A Phase II Trial of G3139 (Genasense) Anti-Bcl-2 Antisense Oligonucleotide Plus Alpha-Interferon in Metastatic Renal 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