An Open-label, Phase II Study Evaluating the Safety and Efficacy of the Addition of Capecitabine (Xeloda®) to Radiation Therapy Compared to Historical Control, in Children With Newly-diagnosed Non-disseminated Intrinsic Diffuse Brain Stem Gliomas.
Phase 2
3 Years
18 Years
3 Years
18 Years
Open (Enrolling)
Both
Glioma
Both
Glioma
Trial Information
An Open-label, Phase II Study Evaluating the Safety and Efficacy of the Addition of Capecitabine (Xeloda®) to Radiation Therapy Compared to Historical Control, in Children With Newly-diagnosed Non-disseminated Intrinsic Diffuse Brain Stem Gliomas.
Inclusion Criteria:
- pediatric and adolescent patients >/=3 to <18 years of age
- patients must have a newly diagnosed non-disseminated intrinsic infiltrating
brainstem glioma
- Karnofsky Performance Scale (if >16 years of age) or Lansky Performance Score (if
/= 50% assessed within two weeks prior to registration to study
- patients must not have received any prior chemotherapy or bone marrow transplant for
the treatment of brainstem glioma. Prior dexamethasone and/or surgery are allowed.
- adequate organ function
Exclusion Criteria:
- patients receiving any other anticancer or experimental drug therapy
- patients with 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:
Progression-free survival: MRI
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
NO21125
NCT ID:
NCT01118377
Start Date:
February 2010
Completion Date:
June 2013
Related Keywords:
- Glioma
- Glioma
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Fountain Valley, California 92708 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Charlotte, North Carolina | |
| Washington, District of Columbia |
