Sarcoma, Kaposi, HIV Infections
Conditions
Keywords
Sarcoma, Kaposi, Acquired Immunodeficiency Syndrome, Interleukin-4
Brief summary
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.
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.
Interventions
DRUGInterleukin-4
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed