MedTrace Logo

Phase 1 Intrathecal Topotecan for Neoplastic Meningitis

NCT00674674 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-05-15

No results posted yet for this study

Summary

1. To find the optimal dose of topotecan that can safely be given directly into the spinal fluid (called intrathecal administration) of children whose cancer has spread to the lining of the brain and/or spinal cord.
2. To find out what effects (good and bad) topotecan has when given directly into the cerebrospinal fluid in children with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord).

* Cerebrospinal fluid is the fluid that circulates around the brain and spinal cord.
3. To determine if intrathecal topotecan is beneficial to patients.
4. To better understand how topotecan is handled by the body after intrathecal administration.
5. To evaluate the cerebrospinal fluid for signs (markers) of tumor spread.

Conditions

  • Neoplastic Meningitis

Interventions

DRUG

Topotecan

Induction (4 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 3. The Induction period is the first 4 weeks of therapy.

DRUG

Topotecan

Consolidation (6 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 4. The Consolidation period is 6 weeks in duration. Consolidation begins immediately after completion of the 4th week of Induction.

DRUG

Topotecan

Maintenance (4 weeks for 11 courses): Patients will receive IT topotecan for 5 consecutive days during week 1. Each course of Maintenance is 4 weeks in duration. Maintenance begins immediately after completion of the 6th week of Consolidation.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Susan Blaney, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2010-08-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674674 on ClinicalTrials.gov