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A Phase I/II Study of Recombinant Interleukin-4 in AIDS and Kaposi's Sarcoma
This study has been completed.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000769
  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 I

Study Type: Interventional
Study Design: Treatment, Open Label, Safety Study
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000769

Locations
United States, California
UCLA CARE Ctr
Los Angeles, California, United States, 90095
United States, Massachusetts
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
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)

Study ID Numbers: ACTG 224
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00000769     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Immunologic Factors
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Adjuvants, Immunologic
Immunologic Deficiency Syndromes
Kaposi Sarcoma
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
HIV Infections
Interleukin-4
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Antirheumatic Agents
Retroviridae Infections

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

ClinicalTrials.gov processed this record on July 02, 2009