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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety