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Brief Title: A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors
Official Title: A Phase I Trial Using Combination Irinotecan and Thalidomide for Recurrent CNS Tumors.
Study ID: NCT00251797
Brief 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)?
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of New Mexico, Albuquerque, New Mexico, United States
Name: Dennie Jones, MD
Affiliation: University of New Mexico
Role: PRINCIPAL_INVESTIGATOR