This trial is active, not recruiting.

Condition kidney cancer
Treatments aldesleukin, recombinant interferon alfa, conventional surgery
Phase phase 2
Sponsor Blumenthal Cancer Center at Carolinas Medical Center
Start date September 1995
Trial size 14 participants
Trial identifier NCT00002847, CDR0000065086, CMC-09-95-14B, NCI-V96-1039


RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic 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 proven renal cell cancer that is metastatic - No greater than 50% estimated hepatic replacement by tumor on CT or MRI - No symptomatic involvement of the CNS or a major nerve - Measurable disease required - Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 50%-100% Life expectancy: - More than 3 months Hematopoietic: - No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: - AST and ALT no greater than 5 times normal Renal: - Creatinine less than 4.0 mg/dL Cardiovascular: - No symptomatic angina - No untreated coronary artery disease - No refractory arrhythmia - No abnormal left ventricular function Pulmonary: - No dyspnea on minimal exertion Other: - No site of ongoing bleeding - No systemic infection - No HIV antibody - No HBsAg - No requirement for steroids - No psychiatric disease that precludes informed consent or protocol treatment - No second malignancy except: - Basal cell skin carcinoma - Carcinoma in situ of the cervix - Not pregnant or nursing - Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy - No prior interleukin-2 Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 28 days since prior treatment for renal cell cancer

Additional Information

Description OBJECTIVES: - Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. - Assess the toxicity of this regimen. OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden. All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 14 patients will be entered.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).