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Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor. Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor  Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor
For Condition: untreated childhood supratentorial primitive neuroectodermal and pineal tumors,untreated childhood medulloblastoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
Synopsis: 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 and combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating children who have newly diagnosed neuroectodermal tumor.
Details: OBJECTIVES: I. Determine the feasible dose and duration of carboplatin combined with craniospinal and local radiotherapy and adjuvant chemotherapy in children with newly diagnosed, high risk primitive neuroectodermal tumor. II. Determine the feasibility of administering cyclophosphamide and vincristine with or without cisplatin following concurrent carboplatin and radiotherapy in these patients. III. Determine the overall and individual toxicity rates of this regimen in these patients. IV. Determine the complete response rate in patients treated with this regimen. V. Obtain preliminary estimates of event free survival in this patient population treated with this regimen. VI. Determine the prognostic significance of enhancing tumor after completion of radiotherapy on event free survival in these patients. PROTOCOL OUTLINE: This is a randomized, dose escalation study of carboplatin. Patients are stratified according to M-stage (M0 vs M1+) and primary site of disease (supratentorial vs infratentorial). Within 31 days of definitive surgery, all patients receive vincristine IV weekly for 6 weeks and carboplatin IV over 15-20 minutes (after completion of vincristine infusion) five days a week for 6 weeks. Patients undergo radiotherapy (1-4 hours after carboplatin infusion) 5 days a week for 6 weeks. Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 12 patients experience dose limiting toxicity. At 6 weeks following completion of radiotherapy, patients are randomized to one of two adjuvant/maintenance chemotherapy arms. Arm I: Patients receive cyclophosphamide IV over 1 hour on days 0 and 1, vincristine IV on days 0 and 7, and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 2 and continuing for at least 10 days until blood counts recover. Arm II: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2, vincristine IV on days 0 and 7, cisplatin IV over 6 hours on day 0, and G-CSF IV or SC beginning on day 3 and continuing for at least 10 days until blood counts recover. Adjuvant/maintenance chemotherapy continues every 4 weeks for 6 courses. Patients are followed every 2 months for 8 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven high risk central nervous system embryonal tumors including: Primitive neuroectodermal tumors; Atypical teratoid/rhabdoid tumor; Medulloblastoma; Desmoplastic medulloblastoma; Ependymoblastoma; Medullomyoblastoma; Spongioblastoma; Spongioblastoma polare; Primitive polar spongioblastoma; Neuroepitheliomatous neoplasms; Medulloepithelioma; Pineoblastoma; Miscellaneous tumors - No bone marrow involvement or bone metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Prior definitive surgery allowed --Patient Characteristics-- - Age: 3 to 21 at diagnosis - Performance status: Not specified - Life expectancy: At least 8 weeks - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count at least 100,000/mm3 (transfusion independent); Hemoglobin at least 10 g/dL (packed red blood cell transfusions allowed) - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT/SGPT less than 2.5 times normal - Renal:Creatinine less than 1.5 times upper limit of normal OR Creatinine clearance at least 70 mL/min
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ReginaJakacki, Study Chair, Children's Cancer Group
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Denver
Denver, Colorado, 80218
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Orange County
Orange, California, 92668
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
IWK Grace Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000066055; CCG-99701
Study Start Date: March 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003203
Other Untreated Childhood Supratentorial Primitive Neuroectodermal And Pineal Tumors Studies:
1. Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
2. Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
3. Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor
Related Studies:
Other untreated childhood supratentorial primitive neuroectodermal and pineal tumors Clinical Trials
Other Utah Clinical Trials
Other Salt Lake City Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Children With Newly Diagnosed Neuroectodermal Tumor
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