Interleukin-2 in Treating Patients With Relapsed or Refractory Acute Myelogenous Leukemia
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill acute myelogenous leukemia cells.
PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients with acute myelogenous leukemia that has relapsed following previous treatment.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||October 1997|
|Primary Completion Date:||April 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003148
|Innsbruck, Austria, A-6020|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|University Hospital Rebro|
|Zagreb, Croatia, 41000|
|Hotel Dieu de Paris|
|Paris, France, 75181|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Azienda Policlinico Umberto Primo|
|Rome, Italy, 00161|
|Ospedale San Eugenio|
|Rome, Italy, 00144|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6252 HB|
|Study Chair:||Roel Willemze, MD, PhD||Leiden University Medical Center|