A Phase I Trial of Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (rHuGM-CSF), Recombinant Alpha Interferon and Azidothymidine (AZT) in AIDS-Associated Kaposi's Sarcoma

Inclusion Criteria Concurrent Medication: Allowed: Prophylaxis for Pneumocystis carinii pneumonia (PCP) with aerosolized pentamidine. Ibuprofen, not to exceed 1600 mg/day, for fever or analgesia. Biopsy-proven Kaposi's sarcoma confined to the skin, lymph nodes, or non-nodular lesions of the hard palate. Positive antibody to HIV confirmed by any federally licensed ELISA test kit. Patients must be able to give informed consent. Allowed: Basal cell carcinoma. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Prior or concurrent opportunistic infection or B symptoms (unexplained fever, night sweats, > 10 percent involuntary weight loss or diarrhea persisting > 2 weeks). Visceral (non-nodal) Kaposi's sarcoma including extensive oral lesions. Severe (> 2+) tumor-associated edema. Concurrent neoplasia (excluding basal cell carcinoma). Significant cardiac disease (New York Heart Association class III or IV) or history of myocardial infarction o significant cardiac arrhythmias. Dementia (= or > stage 2). Concurrent Medication: Excluded: Any systemic chemoprophylaxis not specifically allowed. Aspirin and acetaminophen. Nonsteroidal anti-inflammatory agents not specifically allowed. Corticosteroids. Barbiturates. Other antiviral agents, immunotherapy, hormonal therapy, chemotherapy directed at treatment of viral infection or malignancy. Other investigational agents. Concurrent Treatment: Excluded: Radiation therapy directed at treatment of viral infection or malignancy. Patients with the following are excluded: Prior or concurrent opportunistic infection or B symptoms (unexplained fever, night sweats, > 10 percent involuntary weight loss or diarrhea persisting > 2 weeks). Visceral (non-nodal) Kaposi's sarcoma including extensive oral lesions. Severe (> 2+) tumor-associated edema. Concurrent neoplasia (excluding basal cell carcinoma). Significant cardiac disease (New York Heart Association class III or IV) or history of myocardial infarction or significant cardiac arrhythmias. Dementia (= or > stage 2). Prior Medication: Excluded: Interferon alpha-2b. Granulocyte-macrophage colony-stimulating factor (GM-CSF). Prior grade 3 or grade 4 toxicity during AZT therapy. Excluded within 30 days of study entry: Zidovudine (AZT). Corticosteroids. Biologic response modifiers. Cytotoxic chemotherapy. Antiretroviral agents. Toxicity grades according to NIAID Recommendations for Grading Acute and Subacute Toxic Effects (Adults). Prior Treatment: Excluded within 30 days of study entry: Requirement for red blood cell transfusions within 30 days of study entry. Radiation therapy. Active drug or alcohol abuse.