Status:
COMPLETED
A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Sarcoma, Kaposi
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE1
Brief Summary
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 sa...
Detailed Description
IL-4 exhibits a variety of beneficial effects on the immune system and is a potent inhibitor of Kaposi's sarcoma cells in vitro. Patients are stratified into two groups according to CD4 count (less t...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
April 1 1998
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00000769
End Date
April 1 1998
Last Update
October 28 2021
Active Locations (3)
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1
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
2
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215