This trial is active, not recruiting.

Condition kidney cancer
Treatments aldesleukin, histamine dihydrochloride
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Masking open label
Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).