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

NCT ID: NCT00000769

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1998-04-30

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 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.

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 than 100 cells/mm3 and greater than or equal to 100 cells/mm3) and are enrolled in cohorts of four patients at each of four dose levels of IL-4 per stratum. Within each stratum, if patients at a given dose level have received at least 2 weeks of study therapy and no more than two patients experienced grade 3 or 4 drug-related toxicity, dose escalation in subsequent patients may begin. The MTD is defined as the dose at which 50 percent of patients develop grade 3 or worse toxicity. Patients with CD4 count less than 500 cells/mm3 (per 12/30/94 amendment) must be on antiretroviral therapy during study treatment.

PER AMENDMENT 11/20/95: Group I - enrollment is closed, the objective has been defined. Group II - patients must have CD4 cells greater than or equal to 100/mm3 and less than 500/mm3.

PER AMENDMENT 11/20/95: All patients will receive antiretroviral therapy.

Conditions

Sarcoma, Kaposi; HIV Infections

Keywords

Sarcoma, Kaposi; Acquired Immunodeficiency Syndrome; Interleukin-4

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Interleukin-4

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miles S

Role: STUDY_CHAIR

Scadden D

Role: STUDY_CHAIR

Locations

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

Countries

United States

References

Miles SA, Mitsuyasu R, LaFleur F, Ryback M, Kasden P, Suckow C, Groopman J, Scadden D. Phase I/II trial of interleukin-4 in KS (ACTG 224). Int Conf AIDS. 1994 Aug 7-12;10(1):46 (abstract no 159B)

Reference Type: BACKGROUND

Other Identifiers

11201

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 224

Identifier Type: -

Identifier Source: org_study_id