Viewing Study NCT00003340



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Last Modification Date: 2024-10-26 @ 9:03 AM
Study NCT ID: NCT00003340
Status: COMPLETED
Last Update Posted: 2014-05-02
First Post: 1999-11-01

Brief Title: Cyclophosphamide Plus Topotecan in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Overview

Official Title: A Phase II Study of Cyclophosphamide Followed by Topotecan in Patients With Refractory or Relapsed Acute Myelogenous Leukemia
Status: COMPLETED
Status Verified Date: 2014-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
NCI-G98-1435 None None None
JHOC-97100102 None None None
J-9736 None None None