Treatment of Children With Diffuse Intrinsic Brain Stem Glioma With Standard Dose Irradiation and Vincristine Plus Oral VP-16, A POG Pilot Study
Phase 1
3 Years
21 Years
3 Years
21 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors
Both
Brain and Central Nervous System Tumors
Trial Information
Treatment of Children With Diffuse Intrinsic Brain Stem Glioma With Standard Dose Irradiation and Vincristine Plus Oral VP-16, A POG Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
David N. Korones, MD
Investigator Role:
Study Chair
Investigator Affiliation:
James P. Wilmot Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067127
NCT ID:
NCT00003935
Start Date:
September 1999
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- untreated childhood brain stem glioma
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |
| University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Washington University School of Medicine | Saint Louis, Missouri 63110 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
| Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
| CCOP - Florida Pediatric | Tampa, Florida 33682-7757 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Children's Hospital of Michigan | Detroit, Michigan 48201 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
| East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
| Oklahoma Memorial Hospital | Oklahoma City, Oklahoma 73126-0307 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Northern New Jersey | Hackensack, New Jersey 07601 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| CCOP - Columbia River Program | Portland, Oregon 97213 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
| Keesler Medical Center - Keesler AFB | Keesler AFB, Mississippi 39534-2576 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Eastern Maine Medical Center | Bangor, Maine 04401 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| St. Mary's Hospital | West Palm Beach, Florida 33407 |
| Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
| Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
| University of Missouri-Columbia Hospital and Clinics | Columbia, Missouri 65212 |
| Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
| Schneider Children's Hospital | New Hyde Park, New York 11042 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
| St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
| Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
| Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
| Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| Mission Saint Joseph's Health System | Asheville, North Carolina 28801 |
| Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
| Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Children's Hospital and Health Center | San Diego, California 92123-4282 |
| Children's Memorial Hospital, Chicago | Chicago, Illinois 60614 |
| MBCCOP - South Texas Pediatric | San Antonio, Texas 78284-7810 |
| Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
| Scott and White Clinic | Temple, Texas 76508 |
| James H. Quillen College of Medicine | Johnson City, Tennessee 37614-0622 |
| Carilion Roanoke Community Hospital | Roanoke, Virginia 24013 |
| Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
| University of New Mexico School of Medicine | Albuquerque, New Mexico 87131 |
| St. John's Hospital and Medical Center | Detroit, Michigan 48236 |
| West Virginia University Medical School-Charleston | Charleston, West Virginia 25304 |
| Texas Oncology P.A. | Dallas, Texas 75230-2503 |
