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| 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 |
| 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.
Eligibility| 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:
Contacts and 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 | |
| Study Chair: | Miles S | |
| Study Chair: | Scadden D |
More Information
| 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 |
|
Sarcoma, Kaposi Acquired Immunodeficiency Syndrome Interleukin-4 |
|
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 |
|
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 |