Trial Information

Phase II Study of the Efficacy of rH Interleukin-2 in Patients With Slowly Progressing Acute Myelogenous Leukemia (AML) and With Limited Bone Marrow Blastosis After Autologous Stem Cell Transplantation or Chemotherapy

OBJECTIVES: I. Assess the therapeutic activity of interleukin-2 (IL-2) in patients with
slowly progressing acute myeloid leukemia with limited bone marrow blastosis either in first
relapse after autologous bone marrow or peripheral blood stem cell transplantation, or with
more advanced disease (i.e., refractory to chemotherapy regimens). II. Characterize the
acute side effects of IL-2 in these patients.

OUTLINE: This is an open label, nonrandomized, multicenter study. Patients are stratified
into two categories of prior failed treatments (first relapse after autologous bone marrow
or peripheral blood stem cell transplantation vs first or subsequent relapse either
refractory to or not eligible for further conventional treatment). Interleukin-2 (IL-2) is
administered as a continuous intravenous infusion on 5 consecutive days at daily escalating
doses for the first cycle. When the individual maximum tolerated dose (MTD) has been
determined, 3 more cycles are given at the MTD. There are 3 days of rest between each
treatment cycle. After the induction phase, maintenance cycles of IL-2 are administered
starting 4 weeks after the last induction treatment. Maintenance cycles of IL-2 are
administered subcutaneously on 5 consecutive days every 4 weeks for 2 years, and
subsequently every other month for a maximum of 3 years. Treatment continues until disease
progression or unacceptable toxicity for a maximum of 5 years. Patients are followed every 4
weeks during the first 2 years, then every 8 weeks during the next 3 years or until
documented progression, and then every 3 months until death.

PROJECTED ACCRUAL: A maximum of 86 (57 transplanted; 29 patients nontransplanted) patients
will be accrued into this study within 2 years.