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

NCT00357253 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000484429U01CA081457PBTC-021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Brain and Central Nervous System Tumors

Keywords

untreated childhood brain stem glioma; childhood high-grade cerebral astrocytoma; untreated childhood cerebellar astrocytoma

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of capecitabine rapidly disintegrating tablets (RDT) in combination with radiotherapy

  First 11 weeks of therapy

• Dose-limiting toxicity

  First 11 weeks of therapy

Secondary Outcomes (4)

• Pharmacokinetics of capecitabine RDT measured periodically during course 1

  Day 1 and Day 14 of therapy

• Tumor response

  From day 1 of treatment until off study

• Survival

  From initiation of treatment until death or off study

• 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

Interventions

capecitabine DRUG

This is a dose escalation study. 375, 500, 650, or 850 mg/m2 capecitabine RDT is given orally daily in two divided doses approximately 12 hours apart beginning at the start of radiation therapy and continuing for 9 weeks. After a two week break, patients receive twice daily oral capecitabine, either 900 mg/m2 or 1250 mg/m2, approximately 12 hours apart for 14 days followed by a 7-day rest period for a total of 3 courses.

Also known as: Xeloda

radiation therapy RADIATION

Participants receive local radiation once daily, 5 days/week for 9 weeks for a total dose of 5580 cGy.

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Pediatric Brain Tumor Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (12)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

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

Boston, Massachusetts, 02115, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

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

Houston, Texas, 77030-2399, United States

Location

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma

Interventions

Capecitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Study Officials

• Susan M. Blaney, MD

  Texas Children's Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 27, 2006
• Study Start: January 1, 2006
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 10, 2013

Record last verified: 2013-01

Locations

US (12)