Use of Topotecan in Patients With Refractory Acute Leukemia

This study has been completed.

Sponsor:

Collaborators:

Immunex Corporation

SmithKline Beecham

Amgen

Information provided by:

Department of Veterans Affairs

ClinicalTrials.gov Identifier:

NCT00100477

First received: December 30, 2004

Last updated: January 20, 2009

Last verified: December 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	December 30, 2004
Last Updated Date	January 20, 2009
Start Date ^ICMJE	December 1998
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00100477 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Use of Topotecan in Patients With Refractory Acute Leukemia
Official Title ^ICMJE	Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
Brief Summary	The purpose of this study is to identify the highest tolerated doses in drugs used to treat aggressive leukemia, lymphoma or multiple myeloma not responding to standard chemotherapy treatment. The drugs being used in this study include drugs frequently used in treating such diseases (mitoxantrone and etoposide) as well as a newer drug that has also been shown to be effective (topotecan).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Leukemia Non-Hodgkin's Lymphoma
Intervention ^ICMJE	Drug: Topotecan Drug: Mitozantrone Drug: Etoposide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Patients in the following disease categories will be considered eligible for this study: Any acute leukemia beyond an initial attempt to induce a remission or after relapse, Chronic Myelogenous Leukemia in Blast Phase, Refractory Multiple Myeloma, Refractory non-Hodgkin's and Hodgkin's Lymphoma Patients must be more than 14 days beyond prior myelotoxic chemotherapy. Several other eligibility criteria apply.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00100477
Other Study ID Numbers ^ICMJE	CADE-RCD1
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Department of Veterans Affairs
Collaborators ^ICMJE	Immunex Corporation SmithKline Beecham Amgen
Investigators ^ICMJE	Not Provided
Information Provided By	Department of Veterans Affairs
Verification Date	December 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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