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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
Open (Enrolling)
Both
Glioma

Thank you

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