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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00003935
Other study ID # 9836
Secondary ID POG-9836CDR00000
Status Completed
Phase Phase 1
First received November 1, 1999
Last updated July 25, 2014
Start date September 1999
Est. completion date March 2007

Study information

Verified date July 2014
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vincristine plus etoposide and radiation therapy in treating children who have newly diagnosed brain stem glioma.


Description:

OBJECTIVES: I. Evaluate the efficacy of vincristine plus etoposide with concurrent radiotherapy on one year survival in children with newly diagnosed diffuse intrinsic brain stem glioma. II. Assess the toxicity of this regimen in this patient population.

OUTLINE: Induction: Patients receive oral etoposide daily on days 1-21 and vincristine IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiotherapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine IV on days 1 and 8 and oral etoposide daily on days 1-21. Treatment repeats every 4 weeks for 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date March 2007
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 21 Years
Eligibility DISEASE CHARACTERISTICS: Newly diagnosed diffuse intrinsic brain stem glioma by MRI At least 2/3 of the tumor in the pons Tumor origin clearly in the pons At least 2 clinical features with less than 6 months duration: Cranial nerve deficit Long tract signs Ataxia No diffuse brain stem enlargement secondary to neurofibromatosis No diffuse leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL ALT no greater than 5 times upper limit of normal Renal: Creatinine or GFR normal for age

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No other concurrent chemotherapy No prior chemotherapy Endocrine therapy: Prior glucocorticoids allowed Radiotherapy: No prior radiotherapy Surgery: No prior surgery Other: No other concurrent investigational drugs

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
etoposide

vincristine sulfate

Radiation:
radiation therapy


Locations

Country Name City State
Australia Royal Children's Hospital Parkville Victoria
Canada Alberta Children's Hospital Calgary Alberta
Canada Cross Cancer Institute Edmonton Alberta
Canada Children's Hospital Hamilton Ontario
Canada Hopital Sainte Justine Montreal Quebec
Canada McGill University Health Center - Montreal Children's Hospital Montreal Quebec
Canada Children's Hospital of Eastern Ontario Ottawa Ontario
Canada Centre Hospitalier de L'Universite Laval Sainte Foy Quebec
Canada Hospital for Sick Children Toronto Ontario
Netherlands Academisch Ziekenhuis Groningen Groningen
Puerto Rico San Jorge Childrens Hospital Santurce
Switzerland Swiss Pediatric Oncology Group Bern Bern
Switzerland Clinique de Pediatrie Geneva
United States University of New Mexico School of Medicine Albuquerque New Mexico
United States Mission Saint Joseph's Health System Asheville North Carolina
United States Emory University Hospital - Atlanta Atlanta Georgia
United States Johns Hopkins Oncology Center Baltimore Maryland
United States Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama
United States Boston Floating Hospital Infants and Children Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo New York
United States Vermont Cancer Center Burlington Vermont
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Medical School-Charleston Charleston West Virginia
United States Carolinas Medical Center Charlotte North Carolina
United States Presbyterian Healthcare Charlotte North Carolina
United States Cancer Center at the University of Virginia Charlottesville Virginia
United States Children's Memorial Hospital, Chicago Chicago Illinois
United States Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois
United States University of Missouri-Columbia Hospital and Clinics Columbia Missouri
United States Medical City Dallas Hospital Dallas Texas
United States Simmons Cancer Center - Dallas Dallas Texas
United States Texas Oncology P.A. Dallas Texas
United States Children's Hospital of Michigan Detroit Michigan
United States St. John's Hospital and Medical Center Detroit Michigan
United States Duke Comprehensive Cancer Center Durham North Carolina
United States Inova Fairfax Hospital Falls Church Virginia
United States Hurley Medical Center Flint Michigan
United States Shands Hospital and Clinics, University of Florida Gainesville Florida
United States University of Texas Medical Branch Galveston Texas
United States St. Vincent Hospital Green Bay Wisconsin
United States Children's Hospital of Greenville Hospital System Greenville South Carolina
United States East Carolina University School of Medicine Greenville North Carolina
United States CCOP - Northern New Jersey Hackensack New Jersey
United States Hackensack University Medical Center Hackensack New Jersey
United States Cancer Research Center of Hawaii Honolulu Hawaii
United States Tripler Army Medical Center Honolulu Hawaii
United States Baylor College of Medicine Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States Nemours Children's Clinic Jacksonville Florida
United States James H. Quillen College of Medicine Johnson City Tennessee
United States University of Kansas Medical Center Kansas City Kansas
United States Keesler Medical Center - Keesler AFB Keesler AFB Mississippi
United States University of California San Diego Cancer Center La Jolla California
United States San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas
United States Norris Cotton Cancer Center Lebanon New Hampshire
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Jude Children's Research Hospital Memphis Tennessee
United States Baptist Hospital of Miami Miami Florida
United States Miami Children's Hospital Miami Florida
United States Sylvester Cancer Center, University of Miami Miami Florida
United States Midwest Children's Cancer Center Milwaukee Wisconsin
United States MBCCOP - Gulf Coast Mobile Alabama
United States West Virginia University Hospitals Morgantown West Virginia
United States Yale Comprehensive Cancer Center New Haven Connecticut
United States Schneider Children's Hospital New Hyde Park New York
United States CCOP - Ochsner New Orleans Louisiana
United States MBCCOP - LSU Health Sciences Center New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States Mount Sinai School of Medicine New York New York
United States Hope Children's Hospital Oak Lawn Illinois
United States Oklahoma Memorial Hospital Oklahoma City Oklahoma
United States Walt Disney Memorial Cancer Institute Orlando Florida
United States Lucile Packard Children's Hospital at Stanford Palo Alto California
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Saint Jude Midwest Affiliate Peoria Illinois
United States St. Christopher's Hospital for Children Philadelphia Pennsylvania
United States CCOP - Columbia River Program Portland Oregon
United States Legacy Emanuel Hospital and Health Center Portland Oregon
United States Maine Children's Cancer Program Portland Maine
United States Naval Medical Center, Portsmouth Portsmouth Virginia
United States Massey Cancer Center Richmond Virginia
United States Carilion Roanoke Community Hospital Roanoke Virginia
United States University of Rochester Cancer Center Rochester New York
United States Sutter Cancer Center Sacramento California
United States University of California Davis Medical Center Sacramento California
United States Cardinal Glennon Children's Hospital Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States MBCCOP - South Texas Pediatric San Antonio Texas
United States University of Texas Health Science Center at San Antonio San Antonio Texas
United States Children's Hospital and Health Center San Diego California
United States Kaiser Permanente-Southern California Permanente Medical Group San Diego California
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States All Children's Hospital St. Petersburg Florida
United States State University of New York Health Sciences Center - Stony Brook Stony Brook New York
United States State University of New York - Upstate Medical University Syracuse New York
United States Madigan Army Medical Center Tacoma Washington
United States CCOP - Florida Pediatric Tampa Florida
United States Scott and White Clinic Temple Texas
United States Arizona Cancer Center Tucson Arizona
United States Natalie Warren Bryant Cancer Center Tulsa Oklahoma
United States Walter Reed Army Medical Center Washington District of Columbia
United States St. Mary's Hospital West Palm Beach Florida
United States CCOP - Wichita Wichita Kansas
United States Via Christi Regional Medical Center Wichita Kansas
United States Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina
United States University of Massachusetts Memorial Medical Center Worcester Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Netherlands,  Puerto Rico,  Switzerland, 

References & Publications (1)

Korones DN, Fisher PG, Kretschmar C, Zhou T, Chen Z, Kepner J, Freeman C. Treatment of children with diffuse intrinsic brain stem glioma with radiotherapy, vincristine and oral VP-16: a Children's Oncology Group phase II study. Pediatr Blood Cancer. 2008 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Survival 1 year Yes
Secondary Monitor the toxicity Yes
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