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

Inclusion 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