A Phase I/II Study of Recombinant Interleukin-4 in AIDS and 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.
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
PER AMENDMENT 11/20/95: All patients will receive antiretroviral therapy.
Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment
United States: Federal Government
|UCLA CARE Center CRS||Los Angeles, California 90095|
|Massachusetts General Hospital ACTG CRS||Boston, Massachusetts 02114|
|Beth Israel Deaconess Med. Ctr., ACTG CRS||Boston, Massachusetts 02215|