Use of Topotecan in Patients With Refractory Acute Leukemia

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma; Leukemia
• Interventions: Drug: Topotecan; Drug: Mitozantrone; Drug: Etoposide

• Registration Number: NCT00100477
• Lead Sponsor: US Department of Veterans Affairs

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).

Study Timeline

• Study Start: 1998-08
• Primary Completion: 2001-01
• Study Completion: 2001-06
• Study First Submitted: 2004-12-30
• Study First Submitted QC: 2004-12-30
• Study First Posted: 2004-12-31
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Topotecan	-
Arm 1	Mitozantrone	-
Arm 1	Etoposide	-

Trial Locations

Locations (1)

North Florida/South Georgia Veterans Health System; 🇺🇸 Gainesville, Florida, United States