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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
  Purpose

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).


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Leukemia
Drug: Topotecan
Drug: Mitozantrone
Drug: Etoposide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Official Title: Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Enrollment: 10
Study Start Date: August 1998
Study Completion Date: June 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Drug: Topotecan Drug: Mitozantrone Drug: Etoposide

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100477

Locations
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
Immunex Corporation
SmithKline Beecham
Amgen
Investigators
Principal Investigator: Mark Mainwaring North Florida/South Georgia Veterans Health System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00100477     History of Changes
Other Study ID Numbers: CADE-RCD1
Study First Received: December 30, 2004
Last Updated: September 24, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Multiple Myeloma
Lymphoma
Leukemia
Etoposide
Drug Therapy
Clinical Trials

Additional relevant MeSH terms:
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Etoposide
Topotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014