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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Christie NHS Foundation Trust
• Treatments: Aldesleukin; Histamine; Histamine phosphate; Interleukin-2

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