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Use of Topotecan in Patients With Refractory Acute Leukemia

Sponsor
US Department of Veterans Affairs (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00100477
Collaborator
Immunex Corporation (Industry), SmithKline Beecham (Industry), Amgen (Industry)
10
Enrollment
1
Location
1
Arm
34
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Official Title:
Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
Study Start Date :
Aug 1, 1998
Actual Primary Completion Date :
Jan 1, 2001
Actual Study Completion Date :
Jun 1, 2001

Arms and Interventions

Arm Intervention/Treatment
Other: Arm 1

Drug: Topotecan

Drug: Mitozantrone

Drug: Etoposide

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 North Florida/South Georgia Veterans Health System Gainesville Florida United States 32608

    Sponsors and Collaborators

    • US Department of Veterans Affairs
    • Immunex Corporation
    • SmithKline Beecham
    • Amgen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    US Department of Veterans Affairs
    ClinicalTrials.gov Identifier:
    NCT00100477
    Other Study ID Numbers:
    • CADE-RCD1
    First Posted:
    Dec 31, 2004
    Last Update Posted:
    Sep 25, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by US Department of Veterans Affairs
    Multiple Myeloma
    Lymphoma
    Leukemia
    Etoposide
    Drug Therapy
    Clinical Trials
    Additional relevant MeSH terms:
    Leukemia
    Etoposide
    Mitoxantrone
    Topotecan

    Study Results

    No Results Posted as of Sep 25, 2013