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

Completed · Phase 1

Conditions studied: Sarcoma, Kaposi, HIV Infections

In brief

To determine the safety and tolerance of interleukin-4 (IL-4) in patients with AIDS-related Kaposi's sarcoma. To determine the effects of IL-4 on tumor growth in patients with AIDS-related Kaposi's sarcoma. IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor of Kaposi's sarcoma cells in vitro.

Key facts

Study ID

NCT00000769

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

48

Expected to finish

1998-04-01

Last updated by the study team

2021-10-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA CARE Center CRS — Los Angeles, California, United States
• Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
• Beth Israel Deaconess Med. Ctr., ACTG CRS — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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