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| ID | Type | Description | Link |
|---|---|---|---|
| NYU-P9712 | |||
| NCI-V98-1400 |
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of different regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating children who have newly diagnosed brain tumor.
OBJECTIVES:
OUTLINE: This is a two regimen study based on disease characteristics.
Patients in regimens A, B, and C undergo leukapheresis after receiving filgrastim (G-CSF) by subcutaneous (SC) injections.
After regimen A, B, or C and in the absence of disease progression, patients undergo consolidation myeloablative chemotherapy by receiving carboplatin IV over 4 hours on days -8, -7, and -6, and then thiotepa IV over 3 hours followed by etoposide IV on days -5, -4, and -3. Patients with malignant gliomas or unbiopsied diffuse intrinsic pontine tumors do not receive etoposide. On day 0, patients are reinfused with autologous PBSC. Following recovery from consolidation chemotherapy, patients with radiographic or cytologic evidence of residual disease undergo radiotherapy.
Patients are followed at 3 months, then every 3 months for the first 2 years, then every 6 months for years 2-4, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 96 patients (73 for regimen A and 23 for regimen C) will be accrued for this study. (Regimen B closed to accrual effective 3/30/2000.)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| carboplatin | Drug | |||
| cisplatin | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| leucovorin calcium | Drug | |||
| methotrexate | Drug | |||
| temozolomide |
DISEASE CHARACTERISTICS:
Regimen A:
Posterior fossa medulloblastoma/primitive neuroectodermal tumor (PNET):
Supratentorial PNET, pineoblastoma, cerebral neuroblastoma, ependymoblastoma, medulloepithelioma, medullomyoblastoma:
Brainstem PNET:
Ependymoma or anaplastic ependymoma:
Supratentorial ependymoma:
Metastatic retinoblastoma:
Primary atypical teratoid/rhabdoid tumors of the CNS:
Choroid plexus carcinoma:
Regimen C:
Anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, anaplastic ganglioglioma, other anaplastic mixed gliomas:
Diffuse intrinsic pontine tumors:
The following diagnoses are not eligible:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan L. Finlay, MB, ChB | NYU Langone Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States | ||
| Maine Children's Cancer Program |
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| Drug |
| thiotepa | Drug |
| vincristine sulfate | Drug |
| autologous bone marrow transplantation | Procedure |
| peripheral blood stem cell transplantation | Procedure |
| radiation therapy | Radiation |
| Scarborough |
| Maine |
| 04074-9308 |
| United States |
| Spectrum Health and DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Children's Hospital of Omaha | Omaha | Nebraska | 68114 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | 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 |
| Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| Beth Israel Hospital North | New York | New York | 10128 | United States |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York | 11790-7775 | United States |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | United States |
| Albert Einstein Clinical Cancer Center | The Bronx | New York | 10461 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Wisconsin Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Children's Hospital | Buenos Aires | Buenos Aires | 1425 | Argentina |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009447 | Neuroblastoma |
| D012175 | Retinoblastoma |
| D012509 | Sarcoma |
| D016545 | Choroid Plexus Neoplasms |
| 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 |
| D019572 | Retinal Neoplasms |
| D005134 | Eye Neoplasms |
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D002955 | Leucovorin |
| D008727 | Methotrexate |
| D000077204 | Temozolomide |
| D013852 | Thiotepa |
| D014750 | Vincristine |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D000630 | Aminopterin |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013721 | Triethylenephosphoramide |
| D001388 | Aziridines |
| D001389 | Azirines |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| 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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