Use of Topotecan in Patients With Refractory Acute Leukemia

September 24, 2013 updated by: US Department of Veterans Affairs

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • North Florida/South Georgia Veterans Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Drug: Topotecan
Drug: Etoposide
Drug: Mitozantrone

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Amgen
SmithKline Beecham
Immunex Corporation

Investigators

  • Principal Investigator: Mark Mainwaring, North Florida/South Georgia Veterans Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

January 1, 2001

Study Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

December 30, 2004

First Submitted That Met QC Criteria

December 30, 2004

First Posted (Estimate)

December 31, 2004

Study Record Updates

Last Update Posted (Estimate)

September 25, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CADE-RCD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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