A Dose-escalation Study of Xeloda Plus Radiation Therapy in Pediatric Patients With Newly Diagnosed Non-disseminated, Intrinsic Brainstem Gliomas and High Grade Gliomas.
Phase 1
3 Years
21 Years
3 Years
21 Years
Not Enrolling
Both
Glioma
Both
Glioma
Trial Information
A Dose-escalation Study of Xeloda Plus Radiation Therapy in Pediatric Patients With Newly Diagnosed Non-disseminated, Intrinsic Brainstem Gliomas and High Grade Gliomas.
Inclusion Criteria:
- patients >=3 and <=21 years of age;
- newly diagnosed non-disseminated brainstem glioma or non-disseminated high grade
glioma;
- Karnofsky (if >16 years) or Lansky (if < 16 years) Performance Scale of >=50%;
- adequate organ function.
Exclusion Criteria:
- previous chemotherapy, radiation therapy, immunotherapy or bone marrow transplant;
- uncontrolled infection;
- known DPD deficiency.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
MTD and DLT, measured by clinical and neurological examination, AEs, laboratory parameters.
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Chair
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO18517
NCT ID:
NCT00532948
Start Date:
May 2007
Completion Date:
January 2013
Related Keywords:
- Glioma
- Glioma
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Fountain Valley, California 92708 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Washington, District of Columbia |
