- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100477
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
-
-
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Leukemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Etoposide
- Topotecan
- Mitoxantrone
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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