Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068192 | Registry Identifier | PDQ (Physician Data Query) | |
| NYU-0027H | |||
| NCI-G00-1852 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug or combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating patients who have surgically resected, newly diagnosed medulloblastoma or supratentorial primitive neuroectodermal tumor, or incompletely resected ependymoma.
OBJECTIVES:
OUTLINE: Patients receive dose-intensive induction chemotherapy consisting of cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; and etoposide and cyclophosphamide IV over 1 hour on days 1 and 2. Patients with M1+ disease (i.e., evidence of dissemination beyond primary tumor site) also receive methotrexate IV over 4 hours on day 3. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. Chemotherapy continues every 21-28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo radiotherapy 5 days a week for 6.5 weeks beginning 3-6 weeks after completion of chemotherapy.
Patients are followed at 6 weeks, then every 3 months for 2 years, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| cisplatin | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| methotrexate | Drug | |||
| vincristine sulfate | Drug | |||
| adjuvant therapy | Procedure | |||
| radiation therapy |
DISEASE CHARACTERISTICS:
Histological confirmation of one of the following:
High stage medulloblastoma with neuraxis dissemination (Chang stage M1 or greater)
Primitive neuroectodermal tumor
Ependymoma
Definitive prior surgery within 42 days of study
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan L. Finlay, MB, ChB | Children's Hospital Los Angeles | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027-0700 | United States | ||
| Geisinger Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11835236 | Result | Dhodapkar K, Dunkel IJ, Gardner S, Sapp M, Thoron L, Finlay J. Preliminary results of dose intensive pre-irradiation chemotherapy in patients older than 10 years of age with high risk medulloblastoma and supratentorial primitive neuroectodermal tumors. Med Pediatr Oncol. 2002 Jan;38(1):47-8. doi: 10.1002/mpo.1262. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Radiation |
| Danville |
| Pennsylvania |
| 17822-1320 |
| United States |
| Tom Baker Cancer Centre - Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008527 | Medulloblastoma |
| D004806 | Ependymoma |
| D018242 | Neuroectodermal Tumors, Primitive |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D005910 | Glioma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008727 | Methotrexate |
| D014750 | Vincristine |
| D017024 | Chemotherapy, Adjuvant |
| 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 |
| 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 |
| D009930 | Organic Chemicals |
| 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 |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
Not provided
Not provided