Use of Topotecan in Patients With Refractory Acute Leukemia

Leukemia Clinical Trial

Official title:

Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00100477
• Other study ID #: CADE-RCD1
• Status: Completed
• Phase: Phase 2
• First received: December 30, 2004
• Last updated: September 24, 2013
• Start date: August 1998
• Est. completion date: June 2001

Study information

• Verified date: September 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study

Related Conditions & MeSH terms

• Leukemia
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Topotecan

• Mitozantrone

• Etoposide

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Amgen, Immunex Corporation, SmithKline Beecham

Country where clinical trial is conducted

United States,