interleukin-2 with or without histamine dihydrochloride in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

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.

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.

Eligibility 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

Keywords: stage iv renal cell cancer recurrent renal cell cancer