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Home > "R" Clinical Trials Conditions > Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma  Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
For Condition: untreated childhood medulloblastoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group,Children's Cancer Group
Synopsis: RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective when combined with radiation therapy for treating medulloblastoma. PURPOSE: Randomized phase III trial to compare two combination chemotherapy treatments plus radiation therapy in treating children with newly diagnosed medulloblastoma.
Details: OBJECTIVES: I. Assess whether a cyclophosphamide-containing combination chemotherapy regimen increases progression-free survival compared to a lomustine-containing regimen in children with newly diagnosed, average-risk medulloblastoma. II. Determine progression-free and overall survival of children treated with craniospinal radiotherapy and local boost radiotherapy for a total dose of 5580 cGy followed by adjuvant lomustine/cisplatin/vincristine vs. cyclophosphamide/cisplatin/vincristine. III. Determine the long-term neurocognitive, endocrinologic, and cardiopulmonary sequelae associated with craniospinal radiotherapy, local boost radiotherapy, and adjuvant chemotherapy in these children, and determine whether replacement of lomustine with cyclophosphamide alters the incidence and degree of sequelae. IV. Determine whether cellular and biologic parameters, including tumor molecular genetic analysis, DNA ploidy, mitotic activity markers, and immunohistochemical analysis, are correlated with progression-free survival, overall survival, and patterns of disease relapse in these patients. V. Evaluate the utility of routine magnetic resonance imaging surveillance studies of the head and spine in detecting subclinical recurrent disease. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Following surgery, patients are randomized to one of two groups. The first group receives craniospinal irradiation followed by a boost to the primary tumor. Beginning within 1 week after initiation of radiotherapy, patients receive vincristine weekly for 8 doses. Beginning 6 weeks after the completion of radiotherapy, patients receive adjuvant lomustine/vincristine/cisplatin every 6 weeks for a total of 8 courses. The second group receives craniospinal irradiation plus vincristine as above, followed by adjuvant cyclophosphamide/vincristine/cisplatin every 6 weeks for a total of 8 courses. Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually. PROJECTED ACCRUAL: It is anticipated that 240-300 patients will be entered over 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/22 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Pathologically confirmed posterior fossa medulloblastoma (CCG diagnosis code 2041) - Localized disease required, i.e.: No more than 1.5 square centimeters of residual tumor on postoperative contrast-enhanced CT or MRI (preferably within 72 hours but no more than 14 days after surgery); No evidence of metastatic disease on pre- and postoperative MRI of spine (with dye enhancement) and lumbar cerebrospinal fluid (CSF) cytology within 3 days prior to surgery; Cytologic analysis of ventricular CSF allowed only if medical contraindication to lumbar puncture and with approval of study chairperson - Brain stem involvement eligible --Prior/Concurrent Therapy-- - No prior radiotherapy or chemotherapy (other than corticosteroids); No more than 31 days since definitive surgery --Patient Characteristics-- - Age: 3 to 21 at diagnosis - Performance status: Not specified - Hematopoietic: ANC greater than 1,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 10 g/dL - Hepatic: Bilirubin less than 1.5 mg/dL; ALT less than 1.5 times normal - Renal: Nuclear glomerular filtration rate or creatinine clearance greater than 70 mL/min per 1.73 square meters
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RogerPacker, Study Chair, Children's Cancer Group
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, 22908
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Children's Hospital of Orange County
Orange, California, 92668
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Children's Hospital of Denver
Denver, Colorado, 80218
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
Clinique de Pediatrie
Geneva, , 1211
Switzerland
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
IWK Grace Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
Additional Information:
Study ID Numbers: CDR0000065160; CCG-A9961
Study Start Date: December 1996
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002875
Other Untreated Childhood Medulloblastoma Studies:
1. Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
2. Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
3. Genetic Study of Brain Tumors in Young Children
4. Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
5. Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
Related Studies:
Other untreated childhood medulloblastoma Clinical Trials
Other California Clinical Trials
Other Orange Clinical Trials
Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
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