Phase I study of daily subcutaneous (sc) low dose interleukin-2 (IL-2) in HIV-associated malignancies (Meeting abstract).

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Phase I study of daily subcutaneous (sc) low dose interleukin-2 (IL-2) in HIV-associated malignancies (Meeting abstract).

Proc Annu Meet Am Soc Clin Oncol; 13:A19 1994. Unique Identifier : AIDSLINE ICDB/94600016
Bernstein ZP; Porter M; Grimes P; Caligiuri MA; Dept. of Medicine, Roswell Park Cancer Inst., Buffalo, NY 14263

Abstract: If the increased incidence of malignancy in patients (pts) with HIV infection results from T cell deficiencies, protracted therapy with IL-2 may partially restore the immune response. We have begun a Phase I trial evaluating clinical, pharmacological, and immunological effects of daily sc injection of low dose recombinant (r)IL-2 (Proleukin) for 90 consecutive days to pts with HIV-associated Kaposi's sarcoma or lymphoma. Each pt was either in complete remission (CR) or stable partial remission (SPR) at entry. Pts received one dose of rIL-2 for 90 days. After 30 days off study, pts could be re-entered at a higher dose. To date, 14 courses have been given to 9 pts. One pt, was non-evaluable. Data are shown in a table. Mean CD4+ count prior to therapy was 169 (range 6 to 510), and no significant change has been seen during therapy. rIL-2 can be detected in serum in the pM range 4-6 hr after injection of 9 x 10(5) U/m2/day. TNF alpha or GM-CSF have remained either undetectable or unchanged during rL-2 therapy. Quantification of viral load is pending. 5 pts with HIV-associated lymphoma show no evidence of PD with a mean follow-up of 6.3 mo (range 3 to 10). Prolonged low dose rIL-2 therapy in pts with HIV-associated malignancies is well tolerated and results in measurable serum concentrations of rIL-2. Further assessment of immune modulation and viral burden during rIL-2 administration is currently underway.

Keywords: Comparative Study Dose-Response Relationship, Drug Human HIV Infections/PATHOLOGY/*THERAPY Injections, Subcutaneous Interleukin-2/*ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Leukocyte Count/DRUG EFFECTS Lymphoma, AIDS-Related/PATHOLOGY/*THERAPY Neoplasm Staging Recombinant Proteins/ADMINISTRATION & DOSAGE/ADVERSE EFFECTS Sarcoma, Kaposi's/PATHOLOGY/*THERAPY Skin Neoplasms/PATHOLOGY/*THERAPY ABSTRACT CLINICAL TRIAL CLINICAL TRIAL, PHASE I
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M9480784

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