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Completed

NCT Number: NCT00100477

Use of Topotecan in Patients With Refractory 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).

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Key information

Conditions

Non-Hodgkin's Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan

Drug

Mitozantrone

Drug

etoposide

Drug

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • Amgen
  • Immunex Corporation
  • SmithKline Beecham

Registry information

Official study title

Study of Topoisomerase Inhibition in the Treatment of Acute Leukemia

Important dates

Study start
1998
Primary completion
2001
Study completion
2001
First posted
Dec 31, 2004
Registry last updated
Sep 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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