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.