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Topotecan in Treating Children With Meningeal Cancer That Has Not Responded to Previous Treatment

2014-07-24 14:35:28 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well topotecan works in treating children with meningeal cancer that has not responded to previous treatment.

Description

OBJECTIVES:

- Determine the therapeutic activity of intrathecal topotecan, in terms of response rate and time to CNS progression, in pediatric patients with recurrent or refractory neoplastic meningitis.

- Determine the safety and toxicity of this regimen in these patients.

- Evaluate the concentration of matrix metalloproteinases (MMPs) in the CSF of these patients.

OUTLINE: Patients are stratified according to disease type (acute lymphoblastic leukemia vs other leukemia/lymphoma vs medulloblastoma vs other solid tumors). (Recurrent CNS acute lymphoblastic leukemia stratum only open to accrual as of 11/30/04)

- Induction: Patients receive topotecan intrathecally (IT) over 5 minutes twice weekly for 6 weeks.

- Consolidation: Beginning 1 week after completion of induction, patients receive topotecan IT over 5 minutes weekly for 4 weeks in the absence of disease progression or unacceptable toxicity.

- Maintenance: Beginning 2 weeks after completion of consolidation, patients receive topotecan IT over 5 minutes twice monthly for 4 months and then monthly through year 1.

Patients are followed monthly for 3 months, every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-77 patients will be accrued for this study.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

topotecan hydrochloride

Location

Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham
Alabama
United States
35294

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:35:28-0400

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