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| ID | Type | Description | Link |
|---|---|---|---|
| E4397 | |||
| SWOG-E4397 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| SWOG Cancer Research Network | NETWORK |
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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 and 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 adult patients with brain cancer.
OBJECTIVES:
OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | |||
| cisplatin | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| vincristine sulfate | Drug | |||
| adjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
DISEASE CHARACTERISTICS:
Histologically confirmed central nervous system cancer including:
Must have less than 1 cm of midline shift or no acute elevated intercranial pressure
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Paul L. Moots, MD | Vanderbilt-Ingram Cancer Center | Study Chair |
| Larry Kleinberg, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Study Chair |
| Geoffrey R. Barger, MD | Barbara Ann Karmanos Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | United States | ||
| Veterans Affairs Medical Center - Lakeside Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Moots PL, O'Neill A, Barger GR, et al.: Toxicities associated with chemotherapy followed by craniospinal radiation for adults with poor-risk medulloblastoma/PNET and disseminated ependymoma: a preliminary report of ECOG 4397. [Abstract] J Clin Oncol 22 (Suppl 14): A-1573, 125s, 2004. |
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| Chicago |
| Illinois |
| 60611-4494 |
| United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa | 52403-1206 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309-1016 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| CCOP - Kalamazoo | Kalamazoo | Michigan | 49007-3731 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007 | United States |
| CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | 55416 | United States |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-0002 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-6307 | United States |
| CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin | 54449 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226-3596 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008527 | Medulloblastoma |
| D004806 | Ependymoma |
| 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 |
| D018242 | Neuroectodermal Tumors, Primitive |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| 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 |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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