TREATMENT OF METASTATIC RENAL CELL CARCINOMA WITH LOW-DOSE INTRAVENOUS RECOMBINANT INTERLEUKIN-2
aldesleukin
+ conventional surgery
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: September 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.14 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location