Thioguanine |
6-TG; TG |
Clinical Trial: Combination Chemotherapy in Treating Children With Progressive Brain Tumors
This study is currently recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| recurrent childhood brain stem glioma recurrent childhood visual pathway glioma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma | Drug: carboplatin Drug: lomustine Drug: procarbazine Drug: thioguanine Drug: vincristine Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Carboplatin and Vincristine Versus Thioguanine, Procarbazine, Lomustine, and Vincristine in Children With Progressive Low Grade Astrocytoma
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
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:
Location and Contact Information
Arizona
Phoenix Children's Hospital, Phoenix, Arizona, 85016, United States; Recruiting
California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center, Orange, California, 92868, United States; Recruiting
Children's Hospital and Research Center at Oakland, Oakland, California, 94609-1809, United States; Recruiting
Children's Hospital Central California, Madera, California, 93638-8762, United States; Recruiting
Children's Hospital Los Angeles, Los Angeles, California, 90027-0700, United States; Recruiting
Children's Hospital of Orange County, Orange, California, 92868, United States; Recruiting
City of Hope Comprehensive Cancer Center, Duarte, California, 91010-3000, United States; Recruiting
General Robert Huyser Cancer Center at David Grant Medical Center, Travis Air Force Base, California, 94535, United States; Recruiting
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States; Recruiting
Kaiser Permanente Medical Center - Sacramento, Sacramento, California, 95825, United States; Recruiting
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, 95051-5386, United States; Recruiting
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego, San Diego, California, 92120, United States; Recruiting
Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda, California, 92354, United States; Recruiting
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States; Recruiting
Santa Barbara Cottage Hospital, Santa Barbara, California, 93102, United States; Recruiting
Southern California Permanente Medical Group, Downey, California, 90242, United States; Recruiting
UCSF Comprehensive Cancer Center, San Francisco, California, 94143, United States; Recruiting
Colorado
Children's Hospital Cancer Center, Denver, Colorado, 80218, United States; Recruiting
Presbyterian - St. Luke's Medical Center, Denver, Colorado, 80218, United States; Recruiting
Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center, Farmington, Connecticut, 06360-7106, United States; Recruiting
District of Columbia
Children's National Medical Center, Washington, District of Columbia, 20010-2970, United States; Recruiting
Lombardi Cancer Center at Georgetown University Medical Center, Washington, District of Columbia, 20007, United States; Recruiting
Florida
Broward General Medical Center, Fort Lauderdale, Florida, 33316, United States; Recruiting
Georgia
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus, Atlanta, Georgia, 30342, United States; Recruiting
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah, Georgia, 31405, United States; Recruiting
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, 30912-4000, United States; Recruiting
Medical Center of Central Georgia, Macon, Georgia, 31201, United States; Recruiting
Idaho
Mountain States Tumor Institute - Boise, Boise, Idaho, 83712, United States; Recruiting
Illinois
Lutheran General Cancer Care Center, Park Ridge, Illinois, 60068-1174, United States; Recruiting
Southern Illinois University School of Medicine, Springfield, Illinois, 62794-9658, United States; Recruiting
University of Chicago Cancer Research Center, Chicago, Illinois, 60601, United States; Recruiting
University of Illinois Medical Center, Chicago, Illinois, 60612, United States; Recruiting
Indiana
Riley Children Cancer Center at Riley Hospital for Children, Indianapolis, Indiana, 46202-5225, United States; Recruiting
Iowa
Blank Children's Hospital, Des Moines, Iowa, 50308, United States; Recruiting
Holden Comprehensive Cancer Center at University of Iowa, Iowa City, Iowa, 52242-1009, United States; Recruiting
Kentucky
Kosair Children's Hospital, Louisville, Kentucky, 40202-3830, United States; Recruiting
Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington, Kentucky, 40536-0284, United States; Recruiting
Louisiana
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States; Recruiting
Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore, Maryland, 21215, United States; Recruiting
Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care, Springfield, Massachusetts, 01107, United States; Recruiting
Michigan
Breslin Cancer Center at Ingham Regional Medical Center, Lansing, Michigan, 48910, United States; Recruiting
Bronson Methodist Hospital, Kalamazoo, Michigan, 49007-5364, United States; Recruiting
CCOP - Beaumont, Royal Oak, Michigan, 48073-6769, United States; Recruiting
DeVos Children's Hospital, Grand Rapids, Michigan, 49503, United States; Recruiting
Josephine Ford Cancer Center at Henry Ford Health System, Detroit, Michigan, 48202, United States; Recruiting
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0914, United States; Recruiting
William Beaumont Hospital - Royal Oak, Royal Oak, Michigan, 48073-6769, United States; Recruiting
Minnesota
Children's Hospitals and Clinics - Minneapolis/St. Paul, Minneapolis, Minnesota, 55404, United States; Recruiting
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905, United States; Recruiting
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, 55805, United States; Recruiting
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Missouri
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States; Recruiting
Nebraska
Children's Hospital of Omaha, Omaha, Nebraska, 68114, United States; Recruiting
UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha, Nebraska, 68198-2168, United States; Recruiting
Nevada
Sunrise Hospital and Medical Center, Las Vegas, Nevada, 89109, United States; Recruiting
New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey, 08903, United States; Recruiting
Newark Beth Israel Medical Center, Newark, New Jersey, 07112-2094, United States; Recruiting
St. Barnabas Medical Center, Livingston, New Jersey, 07039, United States; Recruiting
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, 07503, United States; Recruiting
Valerie Fund Children's Center at Atlantic Health, Summit, New Jersey, 07901, United States; Recruiting
New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine, Bronx, New York, 10461, United States; Recruiting
Brookdale University Hospital and Medical Center, Brooklyn, New York, 11212, United States; Recruiting
Brooklyn Hospital Center, Brooklyn, New York, 11201-5493, United States; Recruiting
Cancer Center of Albany Medical Center, Albany, New York, 12208, United States; Recruiting
Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn, New York, 11219, United States; Recruiting
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, 10032, United States; Recruiting
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11794, United States; Recruiting
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
New York Medical College, Valhalla, New York, 10595, United States; Recruiting
New York Weill Cornell Cancer Center at Cornell University, New York, New York, 10021, United States; Recruiting
Schneider Children's Hospital, New Hyde Park, New York, 11042, United States; Recruiting
SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States; Recruiting
SUNY Upstate Medical University Hospital, Syracuse, New York, 13210, United States; Recruiting
North Carolina
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, 28232-2861, United States; Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599, United States; Recruiting
Mission Hospitals, Asheville, North Carolina, 28801, United States; Recruiting
North Dakota
Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo, North Dakota, 58103-4940, United States; Recruiting
Meritcare Roger Maris Cancer Center, Fargo, North Dakota, 58122, United States; Recruiting
Ohio
Children's Hospital Medical Center of Akron, Akron, Ohio, 44308-1062, United States; Recruiting
Children's Medical Center - Dayton, Dayton, Ohio, 45404, United States; Recruiting
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States; Recruiting
Columbus Children's Hospital, Columbus, Ohio, 43205-2696, United States; Recruiting
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106-5065, United States; Recruiting
St. Vincent Mercy Medical Center, Toledo, Ohio, 43608, United States; Recruiting
Toledo Children's Hospital, Toledo, Ohio, 43601, United States; Recruiting
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Doernbecher Children's Hospital at Oregon Health & Science University, Portland, Oregon, 97239-3098, United States; Recruiting
Pennsylvania
Children's Hospital at Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States; Recruiting
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States; Recruiting
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States; Recruiting
Geisinger Medical Center, Danville, Pennsylvania, 17822-1320, United States; Recruiting
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, 57117-5039, United States; Recruiting
Tennessee
East Tennessee Children's Hospital, Knoxville, Tennessee, 37901, United States; Recruiting
East Tennessee State University Cancer Center at Johnson City Medical Center, Johnson City, Tennessee, 37614-0622, United States; Recruiting
Vanderbilt Children's Hospital, Nashville, Tennessee, 37232-6310, United States; Recruiting
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Children's Hospital of Austin, Austin, Texas, 78701, United States; Recruiting
Covenant Children's Hospital, Lubbock, Texas, 79410, United States; Recruiting
MBCCOP - South Texas Pediatrics, San Antonio, Texas, 78229-3900, United States; Recruiting
MD Anderson Cancer Center at University of Texas, Houston, Texas, 77030-4009, United States; Recruiting
Medical City Dallas Hospital, Dallas, Texas, 75230, United States; Recruiting
Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio, Texas, 78229-3902, United States; Recruiting
Texas Tech University Health Sciences Center School of Medicine, Amarillo, Texas, 79106, United States; Recruiting
Virginia
Children's Hospital of the King's Daughters, Norfolk, Virginia, 23507, United States; Recruiting
Washington
Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, 98105, United States; Recruiting
Deaconess Medical Center, Spokane, Washington, 99210-0248, United States; Recruiting
Group Health Central Hospital, Seattle, Washington, 98112, United States; Recruiting
Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, 98415-0299, United States; Recruiting
West Virginia
Cabell Huntington Hospital, Huntington, West Virginia, 25701, United States; Recruiting
Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown, West Virginia, 26506-9300, United States; Recruiting
Wisconsin
Bellin Memorial Hospital, Green Bay, Wisconsin, 54301, United States; Recruiting
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, 54601, United States; Recruiting
Marshfield Clinic - Marshfield Center, Marshfield, Wisconsin, 54449-5772, United States; Recruiting
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-6164, United States; Recruiting
Australia, New South Wales
Sydney Children's Hospital, Randwick, New South Wales, 2031, Australia; Recruiting
Australia, Western Australia
Princess Margaret Hospital for Children, Perth, Western Australia, 6001, Australia; Recruiting
Canada, British Columbia
British Columbia Children's Hospital, Vancouver, British Columbia, V6H 3V4, Canada; Recruiting
Canada, Manitoba
CancerCare Manitoba, Winnipeg, Manitoba, R3E 0V9, Canada; Recruiting
Canada, Newfoundland and Labrador
Janeway Children's Health and Rehabilitation Centre, St. John's, Newfoundland and Labrador, A1B 3V6, Canada; Recruiting
Canada, Nova Scotia
IWK Health Centre, Halifax, Nova Scotia, B3J 3G9, Canada; Recruiting
Canada, Ontario
Children's Hospital of Western Ontario, London, Ontario, N6C 2V5, Canada; Recruiting
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, S4T 7T1, Canada; Recruiting
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, S7N 4H4, Canada; Recruiting
New Zealand
Starship Children's Health, Auckland, New Zealand; Recruiting
Switzerland
Swiss Pediatric Oncology Group Bern, Bern, CH 3010, Switzerland; Recruiting
Swiss Pediatric Oncology Group Geneva, Geneva, CH 1211, Switzerland; Recruiting
Swiss Pediatric Oncology Group Lausanne, Lausanne, CH 1011, Switzerland; Recruiting
Joann Ater, MD, Study Chair, M.D. Anderson Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: May 2004
Last Updated: April 4, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002944
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- TG (Drug Digest)
- Thioguanine (Drug Digest)

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