Topotecan in Treating Patients With Recurrent, Progressive, or Refractory Cancer That is Metastatic to the Lining Around the Brain

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00025311
• Lead Sponsor: NYU Langone Health

Brief Summary

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

PURPOSE: Phase I trial to study the effectiveness of intrathecal or intraventricular topotecan in treating recurrent, progressive, or refractory cancer that is metastatic to the lining around the brain.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose of intrathecal or intraventricular topotecan in patients with recurrent, progressive, or refractory leptomeningeal disease.

* Determine the toxicity of this regimen in these patients.

* Determine the pharmacokinetics of this regimen in these patients.

* Determine the anti-tumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (leukemia or lymphoma vs solid tumor or other malignancy).

Patients receive topotecan intrathecally or intraventricularly continuously on days 1-7. Treatment repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose- limiting toxicity.

Patients are followed for 6 months.

PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study.

Study Timeline

• Study Start: 2001-05
• Study First Submitted: 2001-10-11
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2003-03
• Primary Completion: 2003-10
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (3)

CHU Pitie-Salpetriere; 🇫🇷 Paris, France

Herbert Irving Comprehensive Cancer Center; 🇺🇸 New York, New York, United States

NYU School of Medicine's Kaplan Comprehensive Cancer Center; 🇺🇸 New York, New York, United States