A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma

Inclusion Criteria

Concurrent Medication:

Required:

• Antiretroviral therapy during study treatment only in patients with CD4 count < 500 cells/mm3 (per 12/30/94 amendment).

Allowed:

• G-CSF for a second occurrence of grade 3 or 4 neutropenia (per 12/30/94 amendment).
• Nonsteroidal anti-inflammatory agents including acetaminophen for drug-related fevers.
• Systemic steroids for no more than 1 week in any 30-day period.
• PCP prophylaxis with TMP/SMX, dapsone, or inhaled pentamidine, if patient has a history of PCP or a CD4 count < 250 cells/mm3.

Allowed only in patients with CD4 count < 100 cells/mm3:

• Maintenance doses of ganciclovir, pyrimethamine/sulfa and TMP/SMX for stable, well-controlled opportunistic infections.
• Non-myelosuppressive treatment IND medications.

Prior Medication: Required: PER AMENDMENT 11/20/95:

• Stable dose of antiretroviral therapy required for at least 21 days prior to study entry for all patients. (Changed from - Stable dose of antiretroviral therapy for at least 21 days prior to study entry in patients with CD4 count < 500 cells/mm3 (per 12/30/94 amendment).

Patients must have:

• AIDS-related Kaposi's sarcoma.
• PER AMENDMENT 11/20/95: CD4 lymphocyte count >= 100 but < 500 cells/mm3. (Changed from - HIV infection.)
• PER AMENDMENT 11/20/95: All Patients will receive antiretroviral therapy. (Changed from - Current antiretroviral therapy IF CD4 count < 500 cells/mm3 (per 12/30/94 amendment).)
• No active opportunistic infections requiring induction therapy.
• Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Other active malignancies (except basal cell carcinoma of the skin and in situ cervical cancer).
• Alteration in mental status that may prevent compliance.
• Cardiac functional capacity of Class II or worse OR regional wall abnormalities or abnormal ejection fraction on two-dimensional echocardiogram, if performed.

Concurrent Medication:

Excluded:

• Chemotherapy, interferons, or immune modulators for Kaposi's sarcoma.
• Myelosuppressive agents such as induction doses of ganciclovir, Fansidar (pyrimethamine/sulfadoxine), or any other investigational drugs (with the exception of non-myelosuppressive treatment IND medications in specific patients).
• GM-CSF or erythropoietin (except for a second grade 3/4 neutropenia or anemia).
• G-CSF.

Patients with the following prior conditions are excluded:

• History of myocardial infarction or significant arrhythmias.
• History of symptomatic hypoglycemia.

Prior Medication:

Excluded:

• Systemic therapy (including chemotherapy, interferons, and immune modulators) for Kaposi's sarcoma within 4 weeks prior to study entry.

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