Clinical trial NCT00532948: A Study of Xeloda (Capecitabine) Plus Radiation Therapy in Children With Newly Diagnosed Gliomas
Official title: A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children With Newly Diagnosed Brainstem Gliomas and High Grade Gliomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Capecitabine.
timeFrame: Upto 11 weeks.
measure: Dose Limiting Toxicities (DLTs)
timeFrame: Upto 11 weeks
measure: Number of Participants With Adverse Events (AE)
timeFrame: Up to 06 years
measure: Number of Participants With Baseline Shift From Normal to Low or High in Hematology Parameters
timeFrame: Up to 06 years
measure: Number of Participants With Baseline Shift From Normal to Low or High in Blood Chemistry Parameters
timeFrame: Up to 06 years
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Capecitabine and Its Metabolites (5'-Deoxy-5-Fluorocytidine [5'-DFCR], 5'-Deoxy-5-Fluorouridine [5'-DFUR], 5-Fluorouracil [5-FU] and Alpha-fluoro-beta-alanine [FBAL])
timeFrame: Day 1 and Day 14
measure: Time to Maximum Plasma Concentration (Tmax) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)
timeFrame: Day 1 and Day 14
measure: The Area Under the Plasma Concentration-time Curve From Time of Dosing to the Last Measurable Concentration (AUClast) of Capecitabine and Its Metabolites (5'-DFCR, 5'-DFUR, 5-FU and FBAL)
timeFrame: Day 1 and Day 14
measure: Anti Tumor Activity
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Durham
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: