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

Phase 2
19 Years
Not Enrolling
Recurrent Renal Cell Cancer, Stage IV Renal Cell Cancer

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Trial Information

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


I. To estimate the objective response rate of metastatic renal cancer to the combination of
G3139 plus α-Interferon (α-IFN).


I. To further assess the clinical toxicity of this combination. II. To evaluate the impact
of G3139 plus α-IFN on molecular targets involved in the regulation of apoptosis in tumor
cells and lymphocytes.

III. To evaluate the pharmacokinetics of G3139 when given with α-IFN at this dose and

IV. To evaluate the potential toxicity of this combination on cells of the immune system.

OUTLINE: This is a multicenter study.

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 complete remission (CR) receive an additional 2 courses past

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 20-24

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate based on the Response Evaluation Criteria In Solid Tumors (RECIST)

Outcome Description:

Confidence intervals for the response rate will be established by calculating exact 95% confidence limits for a binomial parameter.

Outcome Time Frame:

Start of the treatment until disease progression/recurrence, assessed up to 5 years

Safety Issue:


Principal Investigator

Kim Margolin

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Recurrent Renal Cell Cancer
  • Stage IV Renal Cell Cancer
  • Carcinoma, Renal Cell



City of Hope Duarte, California  91010