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

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA CARE Center CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ACTG CRS
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med. Ctr., ACTG CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Miles S
  • Study Chair: Scadden D

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

April 1, 1998

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 224
  • 11201 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Interleukin-4

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe