PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs
NCT00385853 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2013-10-21
Summary
PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow. These studies have shown that the study drug can potentially improve the effectiveness of additional radiation and chemotherapy. With this study, we would like to examine the effects of PTK when used in combination with radiation therapy and the anti-cancer drug temozolomide, the standard treatment for patients with newly diagnosed glioblastoma. We would also like to learn how the study drug is absorbed, distributed, and cleared from the body.
Conditions
Interventions
- DRUG
-
PTK787/ZK 222584
Twice daily for each 28-day cycle
- DRUG
-
Daily for each 28-day cycle
- PROCEDURE
-
Radiation Therapy
For 7 weeks beginning on day 5 of the first treatment cycle
Sponsors & Collaborators
- collaborator OTHER
- collaborator INDUSTRY
-
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Tracy Batchelor, MD · Massachusetts General Hospital
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
- 2006-09-30
- Primary Completion
- 2011-09-30
- Completion
- 2011-09-30
Countries
- United States
Study Locations
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