NCT00251797

A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors

A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of New Mexico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will try to answer these questions: 1. What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan? 2. How well does this combination work to shrink brain tumors, and how long do responses to treatment last? 3. What side effects does the combination of drugs cause? 4. How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?

Detailed description

This is a Phase I study, which means these trials are generally comparatively small and are used to determine toxicity and maximum dose. Currently, there are no "standard" treatments for Recurrent CNS Tumors. In this study, approximately 14 patients with Recurrent CNS Tumors will receive treatment with irinotecan, an intravenous drug, and thalidomide, a drug taken by mouth. Both have been approved by the Federal Food and Drug Administration as treatments for cancer, but they have not been tested together for brain cancer. The study will try to answer these questions: 1. What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan? 2. How well does this combination work to shrink brain tumors, and how long do responses to treatment last? 3. What side effects does the combination of drugs cause? 4. How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?

Conditions

• Brain and Nervous System
• Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan	Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days
DRUG	Thalidomide	Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle

Timeline

• Start date: 2000-03-01
• Primary completion: 2006-06-01
• Completion: 2006-06-01
• First posted: 2005-11-10
• Last updated: 2010-01-07

Locations

1 site across 1 country: United States