Subcutaneously Administered Interleukin-2 Therapy in HIV-Infected Patients

Summary

This is a Phase I dose-escalating safety study aimed at identifying the maximum tolerated dose (MTD) for an outpatient regimen while exposing the minimum number of patients to a dose less than MTD. The anticipated accrual will be approximately 15 patients and the study will take one year to complete. Patients will receive Proleukin® (Registered Trademark) subcutaneously at their assigned dose level once per day for 5 days approximately every eight weeks for a total of 6 months. A cycle of therapy is defined as 5 days of Proleukin® (Registered Trademark) plus antiviral therapy followed by 7 weeks of antiviral therapy alone. If tolerated, each patient will receive 3 cycles of therapy and, following completion of three cycles, will be eligible for extended treatment. IL-2 injections will be delivered by study personnel on an outpatient basis for at least the first cycle of therapy.

Timeline

Start

1993-08

Primary completion

—

Completion

2002-04

Publications

• Background Lissoni P, Barni S, Ardizzoia A, Crispino S, Paolorossi F, Archili C, Vaghi M, Tancini G. Second line therapy with low-dose subcutaneous interleukin-2 alone in advanced renal cancer patients resistant to interferon-alpha. Eur J Cancer. 1992;28(1):92-6. doi: 10.1016/0959-8049(92)90393-g.
• Background Lotze MT, Matory YL, Rayner AA, Ettinghausen SE, Vetto JT, Seipp CA, Rosenberg SA. Clinical effects and toxicity of interleukin-2 in patients with cancer. Cancer. 1986 Dec 15;58(12):2764-72. doi: 10.1002/1097-0142(19861215)58:123.0.co;2-z.
• Background McElrath MJ, Kaplan G, Burkhardt RA, Cohn ZA. Cutaneous response to recombinant interleukin 2 in human immunodeficiency virus 1-seropositive individuals. Proc Natl Acad Sci U S A. 1990 Aug;87(15):5783-7. doi: 10.1073/pnas.87.15.5783.

Drugs

Indications