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

NCT ID: NCT00532948

Last Updated: 2016-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-10-31

Brief Summary

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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 will not exceed 30 evaluable patients.

Detailed Description

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Conditions

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Glioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

capecitabine [Xeloda]

Intervention Type DRUG

500mg/m2 po bid (starting dose)

Interventions

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capecitabine [Xeloda]

500mg/m2 po bid (starting dose)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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San Francisco, California, United States

Site Status

Washington D.C., District of Columbia, United States

Site Status

Chicago, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Durham, North Carolina, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Pittsburgh, Pennsylvania, United States

Site Status

Houston, Texas, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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NO18517

Identifier Type: -

Identifier Source: org_study_id