Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of cyclophosphamide plus topotecan in treating patients who have refractory or relapsed acute myelogenous leukemia.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia|
|Study Start Date:||November 1997|
|Study Completion Date:||February 2000|
|Primary Completion Date:||February 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the efficacy of cyclophosphamide followed by topotecan in patients with relapsed or refractory acute myelogenous leukemia. II. Confirm safety and tolerability of this combination on this schedule in these patients.
OUTLINE: Patients receive cyclophosphamide intravenously over 1 hour on day 1 followed by topotecan as a continuous 120 hour infusion starting 12 hours after completion of cyclophosphamide. Treatment may be repeated every 3-6 weeks for at least 2 courses.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003340
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21287|
|Study Chair:||Carole Miller, MD||Sidney Kimmel Comprehensive Cancer Center|