RATIONALE: 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.

PURPOSE: Phase II trial to study the effectiveness of combining oblimersen with interferon alfa in treating patients who have metastatic renal cell (kidney) cancer.

Condition	Treatment or Intervention	Phase
Stage IV Renal Cell Cancer recurrent renal cell cancer	Drug: interferon alfa  Drug: oblimersen  Procedure: antisense therapy  Procedure: biological response modifier therapy  Procedure: cytokine therapy  Procedure: interferon therapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the objective response rate in patients with metastatic renal cell cancer treated with oblimersen and interferon alfa.
• Determine the clinical toxicity of this regimen in these patients.
• Determine the pharmacokinetics of this regimen in these patients.

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 CR.

Patients are followed for survival.

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic renal cell cancer
• Post-nephrectomy progression of metastases must be documented (if nephrectomy was performed in the setting of metastatic disease)
• Measurable disease outside of prior radiation port
• No prior or concurrent brain metastases

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• SWOG 0-2

Life expectancy

• At least 3 months

Hematopoietic

• WBC at least 3,500/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
• Alkaline phosphatase no greater than 2.5 times ULN*
• AST and ALT no greater than 2 times ULN*
• PT/PTT normal
• INR no greater than 1.5 for patients receiving low-dose warfarin (e.g., prophylaxis for a venous access device) NOTE: *Patients with hepatic metastases may have 50% higher levels

Renal

• Creatinine no greater than 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Recovered from prior infection or other medical illness
• Central venous access required
• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• No active or recently treated autoimmune disease
• No psychosocial problems that would compromise safety or study compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

• At least 8 weeks since prior high-dose interleukin-2
• No more than 2 prior biologic therapy regimens, except interferon and oblimerson

Chemotherapy

• At least 3 weeks since prior chemotherapy
• No more than 1 prior chemotherapy regimen
• Recovered from all toxic effects
• No concurrent chemotherapy

Endocrine therapy

• At least 3 weeks since prior steroid therapy
• No concurrent corticosteroids

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy

Surgery

• See Disease Characteristics
• Recovered from prior surgery

Other

• No other concurrent investigational agents
• No concurrent immunosuppressive agents

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting
      City of Hope Medical Group, Pasadena,  California,  91105,  United States; Recruiting
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States; Recruiting
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States; Recruiting
New York
      Comprehensive Cancer Center at Our Lady of Mercy Medical Center, Bronx,  New York,  10466,  United States; Recruiting
Pennsylvania
      Hillman Cancer Center at University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15232,  United States; Recruiting

Study ID Numbers:  CDR0000298756; CCC-PHII-42; CHNMC-PHII-42; NCI-5828; NCT00059813
Record last reviewed:  September 2004
Last Updated:  December 6, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00059813
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08