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A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00532948
First received: September 20, 2007
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This single arm study will assess the maximum tolerated dose, and dose-limiting toxicities, of Xeloda administered concurrently with radiation therapy, in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Xeloda will be administered twice daily, at a starting dose of 500mg/m2 bid, beginning within 24 hours of the start of radiation therapy. Subsequent dose escalations will be in increments of 30%, using a standard dose escalation schema. Post-radiation therapy with Xeloda will continue after a 2 week break. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Glioma
 Drug: capecitabine [Xeloda]
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-escalation Study of Xeloda Plus Radiation Therapy in Pediatric Patients With Newly Diagnosed Non-disseminated, Intrinsic Brainstem Gliomas and High Grade Gliomas.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • MTD and DLT, measured by clinical and neurological examination, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic profile of capecitabine [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Antitumor activity, assessed by MRI scan. [ Time Frame: At intervals throughout study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: capecitabine [Xeloda]
500mg/m2 po bid (starting dose)

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532948

Locations
United States, California
San Francisco, California, United States, 94143-0780
United States, District of Columbia
Washington, District of Columbia, United States, 20010
United States, Illinois
Chicago, Illinois, United States, 60614
United States, Massachusetts
Boston, Massachusetts, United States, 02115-6084
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15261
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00532948     History of Changes
Other Study ID Numbers: NO18517
Study First Received: September 20, 2007
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
 Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013