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.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 21 Years |
Eligibility |
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) |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston | Texas |
United States | Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Houston | Texas |
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Pediatric Brain Tumor Consortium | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy | First 11 weeks of therapy | Yes | |
Primary | Dose-limiting toxicity | First 11 weeks of therapy | Yes | |
Secondary | Pharmacokinetics of capecitabine RDT measured periodically during course 1 | Day 1 and Day 14 of therapy | No | |
Secondary | Tumor response | Brain imaging to assess tumor response to the treatment is performed at baseline, week 11, end of course 6, and then every 3 months for two years. | From day 1 of treatment until off study | No |
Secondary | Survival | From initiation of treatment until death or off study | No | |
Secondary | Radiographic changes in gliomas as measured by MRI, magnetic resonance spectroscopy (MRS), perfusion and diffusion MRI | Baseline, week 11, then every 3 months for 2 years or until off study | No |
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