Use of Topotecan in Patients With Refractory Acute Leukemia

This study has been completed.
Sponsor:
Collaborators:
Immunex Corporation
SmithKline Beecham
Amgen
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00100477
First received: December 30, 2004
Last updated: September 24, 2013
Last verified: September 2013

December 30, 2004
September 24, 2013
August 1998
January 2001   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00100477 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of Topotecan in Patients With Refractory Acute Leukemia
Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia

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).

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).

Interventional
Phase 2
Endpoint Classification: Efficacy Study
  • Non-Hodgkin's Lymphoma
  • Leukemia
  • Drug: Topotecan
  • Drug: Mitozantrone
  • Drug: Etoposide
Arm 1
Interventions:
  • Drug: Topotecan
  • Drug: Mitozantrone
  • Drug: Etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
June 2001
January 2001   (final data collection date for primary outcome measure)

Inclusion Criteria:

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.

Exclusion Criteria:

  • None
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00100477
CADE-RCD1
Not Provided
Department of Veterans Affairs
Department of Veterans Affairs
  • Immunex Corporation
  • SmithKline Beecham
  • Amgen
Principal Investigator: Mark Mainwaring North Florida/South Georgia Veterans Health System
Department of Veterans Affairs
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP