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| Sponsored by: |
New York University School of Medicine |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003273 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma Retinoblastoma Sarcoma |
Biological: filgrastim Drug: carboplatin Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: temozolomide Drug: thiotepa Drug: vincristine sulfate Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Dose Intensive Chemotherapy for Children Less Than Ten Years of Age Newly-Diagnosed With Malignant Brain Tumors: A Pilot Study of Two Alternative Intensive Induction Chemotherapy Regimens, Followed by Consolidation With Myeloablative Chemotherapy (Thiotepa, Etoposide and Carboplatin) and Autologous Stem Cell Rescue |
Eligibility| Ages Eligible for Study: | up to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, Hawaii | |
| Cancer Research Center of Hawaii | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Maine | |
| Maine Children's Cancer Program | |
| Scarborough, Maine, United States, 04074-9308 | |
| United States, Michigan | |
| Spectrum Health and DeVos Children's Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| United States, Nebraska | |
| Children's Hospital of Omaha | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Jersey | |
| Hackensack University Medical Center | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| Albert Einstein Clinical Cancer Center | |
| Bronx, New York, United States, 10461 | |
| Beth Israel Hospital North | |
| New York, New York, United States, 10128 | |
| Herbert Irving Comprehensive Cancer Center | |
| New York, New York, United States, 10032 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| NYU School of Medicine's Kaplan Comprehensive Cancer Center | |
| New York, New York, United States, 10016 | |
| State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| State University of New York Health Sciences Center - Stony Brook | |
| Stony Brook, New York, United States, 11790-7775 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| United States, Ohio | |
| St. Vincent Mercy Medical Center | |
| Toledo, Ohio, United States, 43608 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, Wisconsin | |
| University of Wisconsin Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Argentina | |
| Children's Hospital | |
| Buenos Aires, Argentina, 1425 | |
| Canada, British Columbia | |
| British Columbia Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Study Chair: | Jonathan L. Finlay, MB, ChB | New York University School of Medicine |
More Information
| Study ID Numbers: | CDR0000066174, NYU-P9712, NCI-V98-1400 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00003273 History of Changes |
| Health Authority: | United States: Federal Government |
|
childhood infratentorial ependymoma childhood supratentorial ependymoma localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma extraocular retinoblastoma |
childhood choroid plexus tumor localized unresectable neuroblastoma previously untreated childhood rhabdomyosarcoma untreated childhood supratentorial primitive neuroectodermal tumor untreated childhood medulloblastoma newly diagnosed childhood ependymoma |
|
Retinal Neoplasms Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Retinoblastoma Brain Diseases Neuroepithelioma Methotrexate Etoposide Nervous System Neoplasms Rhabdomyosarcoma Eye Neoplasms Vincristine Carboplatin Temozolomide Thiotepa |
Folic Acid Brain Neoplasms Neuroectodermal Tumors Malignant Mesenchymal Tumor Sarcoma Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial Antimetabolites Choroid Plexus Neoplasms Immunologic Factors Folate Leucovorin Cyclophosphamide Etoposide phosphate Vitamin B9 |
|
Retinal Neoplasms Antimetabolites, Antineoplastic Neuroectodermal Tumors, Primitive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Neoplasms Retinoblastoma Brain Diseases Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents Etoposide Nucleic Acid Synthesis Inhibitors |
Nervous System Neoplasms Eye Neoplasms Nervous System Diseases Vincristine Carboplatin Abortifacient Agents, Nonsteroidal Temozolomide Thiotepa Neuroectodermal Tumors Brain Neoplasms Neoplasms Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Neoplasms, Glandular and Epithelial Antimetabolites |