Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00003340|
Recruitment Status : Completed
First Posted : August 16, 2004
Last Update Posted : May 2, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cyclophosphamide Drug: topotecan hydrochloride||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||February 2000|
|Actual Study Completion Date :||February 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003340
|United States, Maryland|
|Johns Hopkins Oncology Center|
|Baltimore, Maryland, United States, 21287|
|Study Chair:||Carole Miller, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|