Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00003935
First received: November 1, 1999
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Brain Tumors
Central Nervous System Tumors
Drug: etoposide
Drug: vincristine sulfate
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Children With Diffuse Intrinsic Brain Stem Glioma With Standard Dose Irradiation and Vincristine Plus Oral VP-16, A POG Pilot Study

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Monitor the toxicity [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: September 1999
Study Completion Date: March 2007
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Induction: Patients receive oral etoposide daily on days 1-21 and vincristine sulfate IV on days 1, 8, and 15. Treatment repeats every 4 weeks for 2 courses. Patients receive radiation therapy daily for 6 weeks concurrently with induction chemotherapy. Maintenance: One week after induction therapy, patients receive vincristine sulfate 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
Drug: etoposide
Other Names:
  • VP-16
  • VePesid
  • NSC # 141540
Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC # 067574
Radiation: radiation therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003935

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sutter Cancer Center
Sacramento, California, United States, 95816
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States, 92120
Children's Hospital and Health Center
San Diego, California, United States, 92123-4282
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Miami Children's Hospital
Miami, Florida, United States, 33155
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States, 32803
All Children's Hospital
St. Petersburg, Florida, United States, 33701
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Portland, Maine, United States, 04101
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231-2410
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
St. John's Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48503
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States, 87131
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
Mount Sinai School of Medicine
New York, New York, United States, 10029
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Saint Joseph's Health System
Asheville, North Carolina, United States, 28801
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233-3549
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
United States, Oklahoma
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States, 73126-0307
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
United States, Tennessee
James H. Quillen College of Medicine
Johnson City, Tennessee, United States, 37614-0622
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Texas Oncology P.A.
Dallas, Texas, United States, 75230-2503
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209
Baylor College of Medicine
Houston, Texas, United States, 77030
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236-5300
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States, 78229-3900
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
Scott and White Clinic
Temple, Texas, United States, 76508
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22046
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Carilion Roanoke Community Hospital
Roanoke, Virginia, United States, 24029
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
United States, West Virginia
West Virginia University Medical School-Charleston
Charleston, West Virginia, United States, 25304
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9162
United States, Wisconsin
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Centre Hospitalier de L'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9713 EZ
Puerto Rico
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Clinique de Pediatrie
Geneva, Switzerland, 1211
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: David N. Korones, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00003935     History of Changes
Other Study ID Numbers: 9836, POG-9836, CDR0000067127, COG-P9836
Study First Received: November 1, 1999
Last Updated: July 25, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
untreated childhood brain stem glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Etoposide
Vincristine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on September 22, 2014