A PHASE II STUDY OF DAILY SUBCUTANEOUS (SQ) LOW DOSE INTERLEUKIN-2 (IL-2), IN HIV-ASSOCIATED MALIGNANCIES.

Abstract

82 Background: We have previously reported at our Phase I study that prolonged low dose IL-2 (Proleukin™) therapy is well tolerated and immunomodulatory in patients (pts) with AIDS malignancies. We have completed and are now reporting on our Phase II study. Methods: Entrants received daily SQ injection of low dose recombinant rIL-2 (Proleukin) for 90 consecutive days at the previously established maximum tolerated dose (MTD) of 1.2×106 U/m2 qd in pts with complete remission (CR) or stable disease (SD) at entry. After 21 days off study, pts could be re-entered to receive additional courses of therapy. Thirty-seven courses were administered to 22 pts. Six courses were non-evaluable due to non-compliance. An additional 5 courses were reduced to .9×106 U/m2 due to grade 3 toxicity (lethargy and myalgias). One of these individuals was able to tolerate the MTD on her 2nd course. Disease responses for evaluable courses are summarized below. TableThe pt who has been on study for the longest period of time (4 courses), has responded to IL-2 with complete resolution of his residual lymphoma. Immunologic analysis reveals a statistically significant expansion of NK cells as noted in the previous Phase I study and no appreciable change in CD4+, CD8+ cells, naive or memory T-cells. No opportunistic infections have been observed while pts were on study. Serial quantification of plasma HIV load by PCR analysis of Particle-Associated HIV-1 gag RNA copies has not revealed any significant change in viral titer. The data suggest that prolonged rIL-2 therapy at a dose of 1.2×106 U/m2/day is well tolerated in this population and appears to be effective in maintaining disease response in individuals with lymphoma.