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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000769
First received: November 2, 1999
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Interleukin-4
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 48
Study Completion Date: April 1998
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000769

Locations
United States, California
UCLA CARE Center CRS
Los Angeles, California, United States, 90095
United States, Massachusetts
Beth Israel Deaconess Med. Ctr., ACTG CRS
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Investigators
Study Chair: Miles S
Study Chair: Scadden D
  More Information

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)

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000769     History of Changes
Other Study ID Numbers: ACTG 224, 11201
Study First Received: November 2, 1999
Last Updated: April 27, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Interleukin-4

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Sarcoma
Sarcoma, Kaposi
DNA Virus Infections
Herpesviridae Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interleukin-4
Adjuvants, Immunologic
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014