Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
NCT ID: NCT00003846
Last Updated: 2014-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
1999-07-31
2007-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of radiation therapy, chemotherapy and peripheral stem cell transplantation in treating patients with primitive neuroectodermal tumors.
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Detailed Description
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* Determine the safety of postradiotherapy high-dose consolidation chemotherapy with peripheral blood stem cell (PBSC) support in patients with high-risk primitive neuroectodermal tumors.
* Determine the safety of delaying radiotherapy by approximately one month in these patients.
* Determine the maximum tolerated dose of thiotepa in these patients.
* Determine the toxic effects of intensive chemotherapy with PBSC support in these patients.
* Assess the time to hematopoietic recovery after PBSC infusion when intensive chemotherapy is used after craniospinal radiotherapy in these patients.
* Determine the overall and event-free survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of thiotepa during consolidation therapy.
* Induction: Within 31 days of initial surgery, patients receive induction therapy comprising vincristine IV on day 0, cyclophosphamide IV over 2 hours on days 0 and 1, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing for at least 7-10 days. Peripheral blood stem cells (PBSC) are then collected.
* Chemoradiotherapy: After blood cell counts recover, and within 28 days of starting induction, patients begin chemoradiotherapy. Patients receive vincristine IV once weekly for 8 doses. Radiotherapy is administered 5 days a week, for 6 weeks, beginning within the same week as the start of vincristine.
* Consolidation: Therapy begins 4-6 weeks after the last radiation treatment in the absence of disease progression. The first and third course are the same and comprise vincristine IV on day 0, carboplatin IV over 1 hour on days 0 and 1, thiotepa IV over 3 hours on days 2-4, and G-CSF SC daily beginning on day 7. PBSC are reinfused on day 7. The second course comprises vincristine IV on day 0, carboplatin IV over 1 hour on days 0 and 1, cyclophosphamide IV over 2 hours on days 2 and 3, and G-CSF SC daily beginning on day 5. PBSC are reinfused on day 5. Each course lasts 21 days.
For consolidation therapy, cohorts of 6-12 patients each receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 12 patients experience dose-limiting toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-56 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
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filgrastim
carboplatin
cyclophosphamide
thiotepa
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
Interventions
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filgrastim
carboplatin
cyclophosphamide
thiotepa
vincristine sulfate
bone marrow ablation with stem cell support
peripheral blood stem cell transplantation
radiation therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically proven primitive neuroectodermal tumor (PNET) of one of the following types:
* Atypical teratoid/rhabdoid tumor
* Medulloblastoma
* Desmoplastic medulloblastoma
* Ependymoblastoma
* Medullomyoblastoma
* Spongioblastoma
* Spongioblastoma polare
* Primitive polar spongioblastoma
* Medulloepithelioma
* Neuroblastoma
* Pineoblastoma
* Posterior fossa PNET must be M1-3 or M0 with greater than 1.5 cm2 residual disease
* Non posterior fossa PNET and other types must be M0-3
* If M3, must show clear evidence of tumor on MRI
* No marrow involvement or other extraneural metastases
* No M4 disease
* No cord compression requiring emergency radiotherapy
PATIENT CHARACTERISTICS:
Age:
* 3 to 21
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 150,000/mm\^3 (no platelet transfusions)
* Hemoglobin at least 10 g/dL (red blood cell transfusions allowed)
Hepatic:
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST or ALT less than 2.5 times ULN
Renal:
* Creatinine clearance or glomerular filtration rate at least 70 mL/min
Cardiovascular:
* Shortening fraction greater than 27% by echocardiogram OR
* Ejection fraction greater than 47% by MUGA
Pulmonary:
* FEV\_1/FVC greater than 60% except for children who:
* Are uncooperative
* Have no dyspnea at rest
* Have no exercise intolerance
* Have pulse oximetry greater than 94% on room air
Other:
* Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Steroids for increased intracranial pressure allowed
Radiotherapy:
* See Disease Characteristics
* No prior urgent radiotherapy
Surgery:
* Not specified
Other:
* No prior therapy for tumor
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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H. Stacy Nicholson, MD, MPH
Role: STUDY_CHAIR
OHSU Knight Cancer Institute
Locations
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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
Children's Hospital of Denver
Denver, Colorado, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 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
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Countries
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Other Identifiers
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COG-99702
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-99702
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000067006
Identifier Type: OTHER
Identifier Source: secondary_id
99702
Identifier Type: -
Identifier Source: org_study_id
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