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Combination Chemotherapy in Treating Children With Progressive Brain Tumors
This study has been completed.
First Received: November 1, 1999   Last Updated: August 23, 2008   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002944
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: carboplatin
Drug: lomustine
Drug: procarbazine hydrochloride
Drug: thioguanine
Drug: vincristine sulfate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 340
Study Start Date: April 1997
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Compare the event free survival as a result of treatment with carboplatin and vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children with progressive brain tumors.
  • Estimate tumor response rates to each regimen of chemotherapy in these patients.
  • Determine toxic effects and quality of life of children treated with each regimen of chemotherapy.
  • Investigate biological and clinical factors which may predict tumor response and early progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative index by MIB-1 (Ki67)) in these patients.
  • Investigate factors contributing to neuropsychological and endocrine status of children with brain tumors treated without irradiation.

OUTLINE: This is a randomized study. Patients are stratified according to site of disease, status at entry, and pathology. Patients are randomized to one of two treatment arms. Patients with neurofibromatosis are nonrandomly assigned to arm II.

  • Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance beginning on day 84 of induction or upon hematopoietic recovery. Each course consists of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently with the first 3 weeks of carboplatin), followed by 2 weeks of rest.
  • Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4, followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a maximum of 8 courses.

PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.

  Eligibility

Ages Eligible for Study:   up to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Pathologically confirmed low grade residual astrocytomas or other eligible residual tumors of the brain interpreted as low grade (WHO grades I and II) such as the following:

    • Glial Tumors

      • Astrocytic tumors

        • Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic)
        • Pilocytic astrocytoma
        • Pleomorphic xanthoastrocytomas
        • Subependymal giant cell astrocytoma
        • Infantile desmoplastic astrocytoma
      • Low grade oligodendroglial tumors

        • Low grade oligodendroglioma
      • Low grade mixed gliomas

        • Oligo-astrocytoma
    • Neuronal Tumors

      • Ganglioglioma (excluding tumors with anaplastic astrocytic components)
      • Infantile desmoplastic ganglioglioma
    • Chiasmatic-hypothalamic tumor without histologic confirmation
  • All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study
  • Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression
  • Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation
  • Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically
  • No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm

PATIENT CHARACTERISTICS:

Age:

  • Under 10

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3 (arm II)
  • Platelet count greater than 100,000/mm^3 (arm II)

Hepatic:

  • Not specified

Renal:

  • Creatinine less than 1.5 times upper limit of normal for age OR
  • Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for the tumor

Endocrine therapy:

  • Prior corticosteroid therapy allowed

Radiotherapy:

  • No prior radiotherapy for the tumor

Surgery:

  • See Disease Characterisitcs

Other:

  • Prior diuretic therapy allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002944

  Hide Study Locations
Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027-0700
Children's Hospital of Orange County
Orange, California, United States, 92868
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
General Robert Huyser Cancer Center at David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Southern California Permanente Medical Group
Downey, California, United States, 90242
Kaiser Permanente Medical Center - Sacramento
Sacramento, California, United States, 95825
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Santa Barbara Cottage Hospital
Santa Barbara, California, United States, 93102
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-7106
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
Lombardi Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
United States, Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
Atlanta, Georgia, United States, 30342
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31405
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912-4000
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Idaho
Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712
United States, Illinois
University of Illinois Medical Center
Chicago, Illinois, United States, 60612
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9658
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60601
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
United States, Indiana
Riley Children Cancer Center at Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50308
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202-3830
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0284
United States, Louisiana
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01107
United States, Michigan
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States, 48910
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007-5364
CCOP - Beaumont
Royal Oak, Michigan, United States, 48073-6769
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States, 48202
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0914
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073-6769
United States, Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, Nebraska
Children's Hospital of Omaha
Omaha, Nebraska, United States, 68114
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-2168
United States, Nevada
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112-2094
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Valerie Fund Children's Center at Atlantic Health
Summit, New Jersey, United States, 07901
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Brookdale University Hospital and Medical Center
Brooklyn, New York, United States, 11212
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Comprehensive Cancer Center at Maimonides Medical Center
Brooklyn, New York, United States, 11219
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Medical College
Valhalla, New York, United States, 10595
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Mission Hospitals
Asheville, North Carolina, United States, 28801
United States, North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic
Fargo, North Dakota, United States, 58103-4940
Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Columbus Children's Hospital
Columbus, Ohio, United States, 43205-2696
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106-5065
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Children's Hospital
Toledo, Ohio, United States, 43601
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Doernbecher Children's Hospital at Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Children's Hospital at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-1320
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
East Tennessee Children's Hospital
Knoxville, Tennessee, United States, 37901
East Tennessee State University Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37614-0622
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-6310
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Children's Hospital of Austin
Austin, Texas, United States, 78701
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
MBCCOP - South Texas Pediatrics
San Antonio, Texas, United States, 78229-3900
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Methodist Cancer Center at Methodist Specialty and Transplant Hospital
San Antonio, Texas, United States, 78229-3902
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
United States, Virginia
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
Group Health Central Hospital
Seattle, Washington, United States, 98112
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98415-0299
United States, West Virginia
Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449-5772
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Australia, New South Wales
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, British Columbia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3J 3G9
Canada, Ontario
Children's Hospital of Western Ontario
London, Ontario, Canada, N6C 2V5
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
New Zealand
Starship Children's Health
Auckland, New Zealand
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, CH 1211
Swiss Pediatric Oncology Group Lausanne
Lausanne, Switzerland, CH 1011
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Joann Ater, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000065394, COG-A9952, CCG-A9952, POG-A9952, CCG-9952
Study First Received: November 1, 1999
Last Updated: August 23, 2008
ClinicalTrials.gov Identifier: NCT00002944     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood brain stem glioma
recurrent childhood visual pathway glioma
recurrent childhood cerebellar astrocytoma
recurrent childhood cerebral astrocytoma
childhood low-grade cerebellar astrocytoma
childhood low-grade cerebral astrocytoma

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Nervous System Diseases
Lomustine
Thioguanine
Vincristine
Antimitotic Agents
Central Nervous System Neoplasms
Carboplatin
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Procarbazine
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009