A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
NCT00251797 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2010-01-07
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)?
Conditions
- Brain and Nervous System
- Cancer
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
University of New Mexico
lead OTHER
Principal Investigators
-
Dennie Jones, MD · University of New Mexico
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-03-31
- Primary Completion
- 2006-06-30
- Completion
- 2006-06-30
Countries
- United States
Study Locations
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