Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Newly Diagnosed Brain Stem Glioma
NCT ID: NCT00003625
Last Updated: 2014-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
7 participants
INTERVENTIONAL
1998-12-31
2006-04-30
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with newly diagnosed brain stem glioma.
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Detailed Description
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OUTLINE: This is dose escalation study of vincristine. Patients receive radiotherapy daily for 6 weeks with concurrent induction chemotherapy. Induction chemotherapy consists of vincristine IV push weekly for 6 weeks, oral etoposide daily on days 1-21 and 29-49 and cyclosporine IV over 2 hours prior to vincristine followed by a continuous 36 hour infusion. Cohorts of 3-6 patients receive escalating doses of vincristine. If dose limiting toxicity (DLT) occurs in 2 or more of 3-6 patients, the maximum tolerated dose (MTD) has been exceeded and the preceding dose is declared the MTD. Maintenance therapy consists of 6 monthly courses of cyclosporine IV over 36 hours beginning on day 1, vincristine IV push on day 1, and oral etoposide daily for days 1-21. Patients are followed every 6 months for 4 years and then annually thereafter.
PROJECTED ACCRUAL: At least 6 patients will be accrued into this study at a rate of 12 patients per year.
Conditions
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Study Design
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TREATMENT
NONE
Study Groups
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Stratum 1
Concomitant irradiation and vincristine sulfate in esc dose beginning with 0.8 mg/m2, etoposide and Cyclosporine A given over 6 weeks, then monthly maint courses over 6 mths, with no clinical and radiologic progression. Stable disease indicates continuation of therapy. Clinical deterioration within 4 months of completion of radiation therapy must be confirmed to be PD by imaging. Clinical progression even in the absence of imaging changes will be accepted as reflecting disease progression. Steroids dexamethasone (Decadron) given as clinically indicated and tapered as tolerated. Steroids may decrease capillary permeability to chemotherapeutic agents and antagonise the effect of cyclosporin A. Also contributes to the syndrome of seizures and white matter changes seen with cyclosporine in the post BMT period. If steroid use is required, the recommended schedule of Decadron dosing during the 6 week induction course is 8 mg/m2 divided q 6-8 hours.
cyclosporine
etoposide
vincristine sulfate
radiation therapy
Interventions
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cyclosporine
etoposide
vincristine sulfate
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 3 to 21 Performance status: Karnofsky or Lansky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 75,000/mm3 Hepatic: SGPT less than 2 times normal Renal: Creatinine normal for age OR Creatinine clearance greater than 70 mL/min
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Prior steroids at stable or decreasing doses allowed Radiotherapy: No prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents
3 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Mark L. Greenberg, MD
Role: STUDY_CHAIR
The Hospital for Sick Children
Locations
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California San Diego Cancer Center
La Jolla, California, United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States
Sutter Cancer Center
Sacramento, California, United States
Kaiser Permanente-Southern California Permanente Medical Group
San Diego, California, United States
Naval Medical Center - San Diego
San Diego, California, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Walt Disney Memorial Cancer Institute
Orlando, Florida, United States
St. Mary's Hospital
West Palm Beach, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States
Christ Hospital
Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate
Peoria, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Via Christi Regional Medical Center-Saint Francis Campus
Wichita, Kansas, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Maine Children's Cancer Program
Portland, Maine, United States
Johns Hopkins Oncology Center
Baltimore, Maryland, United States
Floating Hospital for Children
Boston, Massachusetts, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
St. John's Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States
Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
University of New Mexico School of Medicine
Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
Buffalo, New York, 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
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States
Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
James H. Quillen College of Medicine
Johnson City, Tennessee, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Scott and White Clinic
Temple, Texas, United States
Vermont Cancer Center
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Madigan Army Medical Center
Tacoma, Washington, United States
West Virginia University Medical School, Charleston Division
Charleston, West Virginia, United States
West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital
Green Bay, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier de L'Universite Laval
Sainte-Foy, Quebec, Canada
Academisch Ziekenhuis Groningen
Groningen, , Netherlands
San Jorge Childrens Hospital
Santurce, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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Other Identifiers
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POG-9879
Identifier Type: -
Identifier Source: secondary_id
CDR0000066706
Identifier Type: -
Identifier Source: secondary_id
9879
Identifier Type: -
Identifier Source: org_study_id
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