Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Biological: aldesleukin
* Drug: histamine dihydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Drug: histamine dihydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer, recurrent renal cell cancer