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.