Multi-Center, Randomized Open-Label Study to Evaluate the Safety and Efficacy of Immunotherapy With Subcutaneous Maxamine (Histamine Dihydrochloride) Plus Proleukin (Interleukin-2) Versus No Treatment (Standard of Care) in Patients With Acute Myeloid Leukemia in First or Subsequent Complete Remission (CR)

Inclusion Criteria

DISEASE CHARACTERISTICS: Cytologically confirmed acute myeloid leukemia (AML) in first
complete remission (CR) or subsequent CR Less than 5% blasts in normal bone marrow Less
than 3 months since last dose of chemotherapy OR Less than 6 months since achieving CR

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 OR Karnofsky 70-100%
Life expectancy: Greater than 3 months Hematopoietic: WBC at least 1,500/mm3 Platelet
count at least 75,000/mm3 Hepatic: PTT normal Bilirubin no greater than 2 times upper
limit of normal (ULN) SGOT and SGPT no greater than 2 times ULN Renal: Creatinine no
greater than 1.5 times ULN Cardiovascular: No class III or IV heart disease No
hypotension, severe hypertension, or serious or uncontrolled cardiac dysrhythmia (e.g.,
ventricular arrhythmias) No acute myocardial infarction within the past 12 months No
active uncontrolled angina pectoris No symptomatic arteriosclerotic blood vessel disease
Pulmonary: No history of asthma within the past 5 years Other: No other active
malignancies except localized basal or squamous cell skin cancer or carcinoma in situ of
the cervix HIV negative No prior or active peptic or esophageal ulcer disease No history
of hypersensitivity to histamine or histamine products, or severe allergies Not pregnant
or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior autologous stem cell transplantation
allowed No prior allogeneic stem cell transplantation No other concurrent immunomodulating
agents Chemotherapy: See Disease Characteristics Prior induction or consolidation therapy
allowed No concurrent chemotherapy Endocrine therapy: At least 24 hours since prior
corticosteroids No concurrent steroids Radiotherapy: Not specified Surgery: Not specified
Other: No concurrent alternative therapy (e.g., laetrile, Brudzinski's treatment, etc.)