Carboplatin and Vincristine Plus Radiation Therapy Followed By Adjuvant Chemotherapy in Treating Young Patients With Newly Diagnosed CNS Embryonal Tumors
NCT ID: NCT00003203
Last Updated: 2013-08-23
Study Results
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Basic Information
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COMPLETED
PHASE2
168 participants
INTERVENTIONAL
1998-03-31
2012-03-31
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy followed adjuvant chemotherapy in treating young patients who have newly diagnosed high-risk CNS embryonal tumors.
Detailed Description
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* Determine the feasible dose and duration of carboplatin combined with craniospinal and local radiotherapy and adjuvant chemotherapy in children with newly diagnosed, high-risk CNS embryonal tumors (Phase I completed as of 11-25-03).
* Determine the feasibility of administering cyclophosphamide and vincristine with or without cisplatin after concurrent carboplatin, vincristine, and radiotherapy in these patients.
* Determine the overall and individual toxicity rates of this regimen in these patients.
* Determine the complete response rate in patients treated with this regimen.
* Obtain preliminary estimates of event-free survival of patients treated with this regimen.
* Determine the prognostic significance of enhancing tumor after completion of radiotherapy on event-free survival of these patients.
OUTLINE: This is a pilot, dose-escalation study of carboplatin. (Phase I completed as of 11-25-03.)
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) 5 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. (Phase I completed as of 11-25-03.)
At 6 weeks after completion of radiotherapy, patients are assigned to arm II for adjuvant/maintenance chemotherapy. (Arm I closed to accrual as of 11-25-03.)
* Arm I (closed to accrual as of 11-25-03): 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.
In both arms, adjuvant/maintenance chemotherapy repeats every 4 weeks for 6 courses.
Patients are followed every 3 months for 8 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Newly diagnosed cerebral PNET with histologic verification
Begin therapy within 31 days of surgery. Radiation therapy will be given in standard fractions along with filgrastim. The craniospinal axis will be treated first. Patients will receive carboplatin at 35 mg/m2/day IV over 15-20 minutes Monday through Friday, 1-4 hours prior to radiation for 6 weeks (total of 30 doses). Vincristine sulfate 1.5 mg/m2 IV will be given weekly x 6. Following radiation, patients will receive Maintenance chemotherapy. Patients enrolled prior to Amendment #5 will receive six cycles of cyclophosphamide and vincristine (Regimen A). Patients enrolled after Amendment #5 will receive six cycles of cyclophosphamide, vincristine sulfate and cisplatin (Regimen B).
filgrastim
Given IV
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
adjuvant therapy
radiation therapy
1.8 Gy/fx x 20fx=36Gy Craniospinal XRT\*
Interventions
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filgrastim
Given IV
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
vincristine sulfate
Given IV
adjuvant therapy
radiation therapy
1.8 Gy/fx x 20fx=36Gy Craniospinal XRT\*
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven high-risk CNS embryonal tumors, including:
* Primitive neuroectodermal tumors
* Atypical teratoid/rhabdoid tumor
* Medulloblastoma
* Desmoplastic medulloblastoma
* Ependymoblastoma
* Medullomyoblastoma
* Spongioblastoma
* Spongioblastoma polare
* Primitive polar spongioblastoma
* Neuroepitheliomatous neoplasms
* Medulloepithelioma
* Neuroblastoma
* Pineoblastoma
* No bone marrow involvement or bone metastases
* No M4 disease
* M3 disease must have evidence of tumor on spinal MRI
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/mm\^3
* Platelet count at least 100,000/mm\^3 (transfusion independent)
* Hemoglobin at least 10.0 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 or radioisotope glomerular filtration rate at least 70 mL/min
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy
Surgery:
* Prior definitive surgery allowed
3 Years
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Regina Jakacki, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
CCOP - Merit Care Hospital
Fargo, North Dakota, United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt Cancer Center
Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
IWK Grace Health Centre
Halifax, Nova Scotia, Canada
Countries
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References
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Jakacki RI, Burger PC, Zhou T, Holmes EJ, Kocak M, Onar A, Goldwein J, Mehta M, Packer RJ, Tarbell N, Fitz C, Vezina G, Hilden J, Pollack IF. Outcome of children with metastatic medulloblastoma treated with carboplatin during craniospinal radiotherapy: a Children's Oncology Group Phase I/II study. J Clin Oncol. 2012 Jul 20;30(21):2648-53. doi: 10.1200/JCO.2011.40.2792. Epub 2012 Jun 4.
Jakacki R, Burger P, Zhou T, et al.: Outcome for metastatic (M+) medulloblastoma (MB) treated with carboplatin during craniospinal radiotherapy (CSRT) followed by cyclophosphamide (CPM) and vincristine (VCR): preliminary results of COG 99701. [Abstract] J Clin Oncol 25 (Suppl 18): A-2017, 2007.
Other Identifiers
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COG-A9971
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-99701
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000066055
Identifier Type: OTHER
Identifier Source: secondary_id
A9971
Identifier Type: -
Identifier Source: org_study_id