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Use of Topotecan in Patients With Refractory Acute Leukemia

Primary Purpose

Non-Hodgkin's Lymphoma, Leukemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Topotecan
Mitozantrone
Etoposide
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Non-Hodgkin's Lymphoma focused on measuring Multiple Myeloma, Lymphoma, Leukemia, Etoposide, Drug Therapy, Clinical Trials

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 30, 2004
Last Updated
September 24, 2013
Sponsor
US Department of Veterans Affairs
Collaborators
Immunex Corporation, SmithKline Beecham, Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT00100477
Brief Title
Use of Topotecan in Patients With Refractory Acute Leukemia
Official Title
Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
June 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Immunex Corporation, SmithKline Beecham, Amgen

4. Oversight

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Leukemia
Keywords
Multiple Myeloma, Lymphoma, Leukemia, Etoposide, Drug Therapy, Clinical Trials

7. Study Design

Study Phase
Phase 2
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Topotecan
Intervention Type
Drug
Intervention Name(s)
Mitozantrone
Intervention Type
Drug
Intervention Name(s)
Etoposide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mainwaring
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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Use of Topotecan in Patients With Refractory Acute Leukemia

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