Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
This trial is active, not recruiting.
|Treatments||aldesleukin, histamine dihydrochloride|
|Sponsor||Christie Hospital NHS Foundation Trust|
|Start date||June 1999|
|Trial identifier||NCT00005038, CDR0000067627, CHNT-IL2-MAXAMINE, EU-99048, MAXIM-MP-502|
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.
Male or female participants from 18 years up to 75 years old.
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
|Official title||A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy With Subcutaneous Interleukin-2 and Maxamine in Patients With Metastatic Renal Cell Carcinoma|
|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.|
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