- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003846
Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
Treatment of High Risk Central Nervous System Embryonal Tumors With Conventional Radiotherapy and Intensive Consolidation Chemotherapy With Peripheral Blood Progenitor Cell (PBSC) Support
RATIONALE: Radiation therapy uses 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. Peripheral stem cell transplantation may allow doctors to give higher doses of radiation therapy and chemotherapy and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy, chemotherapy and peripheral stem cell transplantation in treating patients with primitive neuroectodermal tumors.
Study Overview
Status
Detailed Description
OBJECTIVES:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
-
Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, United States, 92668
- Children's Hospital of Orange County
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-
Colorado
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Denver, Colorado, United States, 80218
- Children's Hospital of Denver
-
-
District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
-
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Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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-
New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
-
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Ohio
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Cincinnati, Ohio, United States, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Columbus, Ohio, United States, 43205-2696
- Children's Hospital of Columbus
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Oregon
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Portland, Oregon, United States, 97201-3098
- Oregon Cancer Center at Oregon Health Sciences University
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Texas
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Houston, Texas, United States, 77030
- University of Texas - MD Anderson Cancer Center
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
See detailed description.
|
Other Names:
Other Names:
Other Names:
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Event Free Survival
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: H. Stacy Nicholson, MD, MPH, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive, Peripheral
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Neuroblastoma
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Cyclophosphamide
- Carboplatin
- Vincristine
- Thiotepa
Other Study ID Numbers
- 99702
- COG-99702 (Other Identifier: Children's Oncology Group)
- CCG-99702 (Other Identifier: Children's Cancer Group)
- CDR0000067006 (Other Identifier: Clinical Trials.gov)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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