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| ID | Type | Description | Link |
|---|---|---|---|
| COG-99702 | Other Identifier | Children's Oncology Group | |
| CCG-99702 | Other Identifier | Children's Cancer Group | |
| CDR0000067006 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of thiotepa during consolidation therapy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | See detailed description. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Event Free Survival |
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DISEASE CHARACTERISTICS:
Histologically proven primitive neuroectodermal tumor (PNET) of one of the following types:
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
No marrow involvement or other extraneural metastases
No M4 disease
No cord compression requiring emergency radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
FEV_1/FVC greater than 60% except for children who:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| H. Stacy Nicholson, MD, MPH | OHSU Knight Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Jonsson Comprehensive Cancer Center, UCLA |
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| carboplatin |
| Drug |
|
|
| cyclophosphamide | Drug |
|
|
| thiotepa | Drug |
|
|
| vincristine sulfate | Drug |
|
|
| bone marrow ablation with stem cell support | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| radiation therapy | Radiation |
|
| Los Angeles |
| California |
| 90095-1781 |
| United States |
| Children's Hospital of Orange County | Orange | California | 92668 | United States |
| Children's Hospital of Denver | Denver | Colorado | 80218 | United States |
| 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 |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | New York | New York | 10016 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | United States |
| Children's Hospital Medical Center - Cincinnati | Cincinnati | Ohio | 45229-3039 | United States |
| Children's Hospital of Columbus | Columbus | Ohio | 43205-2696 | United States |
| Oregon Cancer Center at Oregon Health Sciences University | Portland | Oregon | 97201-3098 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D016190 | Carboplatin |
| D003520 | Cyclophosphamide |
| D013852 | Thiotepa |
| D013721 | Triethylenephosphoramide |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001388 | Aziridines |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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