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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000769 |
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 |
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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 |
Estimated Enrollment: | 48 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Required:
Allowed:
Allowed only in patients with CD4 count < 100 cells/mm3:
Prior Medication: Required: PER AMENDMENT 11/20/95:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
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 |
Study Chair: | Miles S | |
Study Chair: | Scadden D |
Study ID Numbers: | ACTG 224 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000769 |
Health Authority: | United States: Federal Government |
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Interleukin-4 |
Sexually Transmitted Diseases, Viral Malignant mesenchymal tumor Acquired Immunodeficiency Syndrome Sarcoma, Kaposi Soft tissue sarcomas Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
Neoplasms, Connective and Soft Tissue Kaposi sarcoma HIV Infections Interleukin-4 Sexually Transmitted Diseases Sarcoma DNA Virus Infections Retroviridae Infections |
RNA Virus Infections Slow Virus Diseases Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Adjuvants, Immunologic |
Infection Pharmacologic Actions Neoplasms Therapeutic Uses Lentivirus Infections Neoplasms, Vascular Tissue Antirheumatic Agents |