This trial is active, not recruiting.

Condition kidney cancer
Treatments aldesleukin, conventional surgery
Phase phase 2
Sponsor Blumenthal Cancer Center at Carolinas Medical Center
Start date September 1995
Trial size 14 participants
Trial identifier NCT00002846, CDR0000065085, CMC-09-95-15B, NCI-V96-1038


RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells.

PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent - No central nervous system or major nerve involvement - No more than 25% estimated hepatic replacement by tumor on CT or MRI - Measurable disease required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80%-100% Life expectancy: - Greater than 3 months Hematopoietic: - Platelet count at least 80,000/mm3 Hepatic: - Bilirubin normal - AST and ALT no greater than 3 times normal Renal: - Creatinine normal Cardiovascular: - Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG) Pulmonary: - FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray) Other: - No sites of ongoing bleeding - No HIV antibody or AIDS - No hepatitis B antigen - No systemic infection - No requirement for steroids - No psychiatric disease that precludes informed consent or safe administration of immunotherapy - No second malignancy except: - Basal cell carcinoma - In situ cervical cancer - Other cancer provided all evaluable lesions are documented RCC - No pregnant or nursing women - Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy - No prior interleukin-2 therapy Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 28 days since therapy for RCC

Additional Information

Description OBJECTIVES: - Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2. - Assess the toxicity associated with this treatment. OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited. Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).