Kidney Cancer
Conditions
Keywords
stage IV renal cell cancer, recurrent renal cell cancer
Brief summary
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Histamine dihydrochloride may prolong survival and improve quality of life in patients with metastatic kidney cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer.
Detailed description
OBJECTIVES: * Determine the clinical efficacy and safety of subcutaneous (SC) histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal cell carcinoma in terms of survival at 1 year, objective tumor response rate, duration of response, and median survival. OUTLINE: This is a randomized, open label study. Patients are randomized to receive interleukin-2 (IL-2) with or without histamine dihydrochloride. * Arm I: Patients receive IL-2 subcutaneously (SC) once daily and histamine dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest. * Arm II: Patients receive IL-2 as in arm I. Treatment continues for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Bidimensionally measurable disease * No clinical evidence of CNS metastases PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Hemoglobin greater than 10.0 g/dL * WBC greater than 3,000/mm3 * Platelet count greater than 100,000/mm3 Hepatic: * PTT normal * Bilirubin less than 1.25 times upper limit of normal (ULN) Renal: * Creatinine less than 1.5 times ULN Cardiovascular: * No abnormal cardiac function by resting ECG Pulmonary: * FEV and FVC at least 70% predicted * SaO2 at least 90% by pulse oximetry Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No clinically significant acute viral, bacterial, or fungal infection requiring specific therapy * No pheochromocytoma * No glaucoma * No other concurrent ongoing active malignancy except carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin * No serious recent nonmalignant medical complication that would preclude study therapy * No organ grafts except skin grafts, blood transfusions, or bone marrow or stem cell transplantation * No prior documented asthma or systemic allergic reaction within past 5 years * No history of seizures, CNS disorders, or psychiatric disability that would preclude study compliance * No medical, sociologic, or psychological impediment that would preclude study compliance * No active peptic or esophageal ulcer disease * No prior peptic or esophageal ulcer disease with history of bleeding * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) * No concurrent chemotherapy Endocrine therapy: * At least 24 hours since prior steroids * No concurrent steroids including steroid therapy for documented adrenal failure or septic shock * Concurrent noncorticosteroid hormones for nonmalignancy conditions allowed Radiotherapy: * At least 4 weeks since prior extensive radiotherapy * No concurrent radiotherapy to measurable malignant masses Surgery: * Not specified Other: * At least 24 hours since prior beta blockers or clonidine * No other concurrent systemic antimalignancy therapy * No other concurrent antitumor agents * No other concurrent investigational agents * No concurrent beta blockers or clonidine * No concurrent H2 receptor antagonists (e.g., Zantac, Tagamet) (arm I only) * No concurrent antihistamines except to treat acute colds or allergy symptoms
Countries
United Kingdom