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Use of Topotecan in Patients With Refractory Acute Leukemia

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ClinicalTrials.gov Identifier: NCT00100477
Recruitment Status : Completed
First Posted : December 31, 2004
Last Update Posted : September 25, 2013
Sponsor:
Collaborators:
Immunex Corporation
SmithKline Beecham
Amgen
Information provided by (Responsible Party):
VA Office of Research and Development

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).

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

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Official Title: Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
Study Start Date : August 1998
Actual Primary Completion Date : January 2001
Actual Study Completion Date : June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia
Drug Information available for: Topotecan

Arm Intervention/treatment
Arm 1 Drug: Topotecan
Drug: Mitozantrone
Drug: Etoposide




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

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): NCT00100477


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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00100477     History of Changes
Other Study ID Numbers: CADE-RCD1
First Posted: December 31, 2004    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Keywords provided by VA Office of Research and Development:
Multiple Myeloma
Lymphoma
Leukemia
Etoposide
Drug Therapy
Clinical Trials

Additional relevant MeSH terms:
Leukemia
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide
Mitoxantrone
Etoposide phosphate
Topotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs