A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.
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)?
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tolerable dosage of thalidomide in combination with irinotecan
Dennie Jones, MD
University of New Mexico
United States: Institutional Review Board
|University of New Mexico||Albuquerque, New Mexico 87131|