cropped color_logo_with_background.png

Capecitabine and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Nonmetastatic Brain Stem Glioma or High-Grade Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 3 Years - 21 Years
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - One of the following newly diagnosed, nondisseminated brain tumors: - Intrinsic infiltrating brain stem glioma.
  • - Histopathologic diagnosis not required.
  • - Histopathologically confirmed high-grade glioma, meeting all of the following criteria: - Underwent prior definitive surgery ≤ 28 days ago with incompletely resected disease.
  • - Any of the following subtypes allowed: - Anaplastic astrocytoma.
  • - Glioblastoma multiforme.
  • - Other high-grade glioma.
  • - No anaplastic oligodendroglioma.
PATIENT CHARACTERISTICS:
  • - Karnofsky performance scale (PS) 50-100% (if > 16 years of age) or Lansky PS 50-100% (if ≤ 16 years of age) - Absolute neutrophil count ≥ 1,000/mm³ - Platelet count ≥ 100,000/mm³ (transfusion independent) - Hemoglobin ≥ 8 g/dL (transfusion independent) - Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR creatinine based on age as follows: - No more than 0.8 mg/dL (for patients 5 years of age and under) - No more than 1 mg/dL (for patients 6-10 years of age) - No more than 1.2 mg/dL (for patients 11-15 years of age) - No more than 1.5 mg/dL (for patients over 15 years of age) - Bilirubin ≤ 1.5 times upper limit of normal (ULN) - ALT ≤ 5 times ULN.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - No uncontrolled infection.
  • - No significant cardiac, hepatic, gastrointestinal, renal, pulmonary, or other systemic disease.
  • - No known hypersensitivity to capecitabine or any of its components.
  • - No known dihydropyrimidine dehydrogenase (DPD) deficiency.
PRIOR CONCURRENT THERAPY:
  • - See Disease Characteristics.
  • - Prior dexamethasone and/or surgery allowed.
  • - No prior chemotherapy, radiotherapy, immunotherapy, or bone marrow transplantation.
  • - No other concurrent anticancer or experimental drug therapies or agents.
- No concurrent warfarin or sorivudine or its chemically related analogues (e.g., brivudine)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00357253
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pediatric Brain Tumor Consortium
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Susan M. Blaney, MD
Principal Investigator Affiliation Texas Children's Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

San Francisco, California

Status

Address

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115

Children's National Medical Center, Washington, District of Columbia

Status

Address

Children's National Medical Center

Washington, District of Columbia, 20010-2970

Children's Memorial Hospital - Chicago, Chicago, Illinois

Status

Address

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614

Bethesda, Maryland

Status

Address

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182

Boston, Massachusetts

Status

Address

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Duke Comprehensive Cancer Center, Durham, North Carolina

Status

Address

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Houston, Texas

Status

Address

Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital

Houston, Texas, 77030-2399

Houston, Texas

Status

Address

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030

Seattle, Washington

Status

Address

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105