Brain and Central Nervous System Tumors Clinical Trial
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
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may make tumor
cells more sensitive to radiation therapy. Giving capecitabine together with radiation
therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of capecitabine when
given together with radiation therapy in treating young patients with newly diagnosed,
nonmetastatic brain stem glioma or high-grade glioma.
OBJECTIVES:
Primary
- Estimate the maximum tolerated dose of capecitabine rapidly disintegrating tablets
(RDT) administered concurrently with radiotherapy in young patients with newly
diagnosed, nondisseminated intrinsic brain stem glioma or high-grade glioma.
- Describe the dose-limiting toxicity in patients treated with this regimen.
Secondary
- Describe the safety profile of this regimen.
- Characterize the pharmacokinetics of capecitabine RDT in these patients.
- Explore the exposure-response relationship for measures of safety and effectiveness
using pharmacokinetic and pharmacodynamic models.
- Describe the antitumor activity of this regimen observed in these patients.
- Estimate distributions of progression-free survival and survival in patients treated
with this regimen.
- Characterize radiographic changes in tumor, using MRI, perfusion and diffusion MRI, and
positron emission tomography (PET) scans, in patients treated with this regimen.
OUTLINE: This a multicenter, dose-escalation study of capecitabine rapidly disintegrating
tablets (RDT).
Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks.
Beginning within 24 hours of starting radiotherapy, patients also receive oral capecitabine
RDT twice daily on days 1-21. Treatment with capecitabine RDT repeats every 21 days for 3
courses.
Cohorts of 3-6 patients receive escalating doses of capecitabine RDT until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose-limiting toxicity.
Beginning in week 12, patients receive capecitabine RDT at a fixed dose twice daily on days
1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity.
Patients undergo blood collection periodically during course 1 for pharmacokinetic
correlative studies. Patients also undergo MRI, and rapid perfusion/diffusion MRI at
baseline and periodically during study for radiographic correlative studies.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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