Brain Tumors Clinical Trial
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
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 |
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.
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, Netherlands, Puerto Rico, Switzerland,
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
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---|---|---|---|---|
Primary | Survival | 1 year | Yes | |
Secondary | Monitor the toxicity | Yes |
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