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| ID | Type | Description | Link |
|---|---|---|---|
| POG-9631 | Other Identifier | Pediatric Oncology Group | |
| CDR0000066640 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy followed by combination chemotherapy in treating children with newly diagnosed advanced medulloblastoma.
OBJECTIVES:
OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).
Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and annually thereafter.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1, Etoposide, 50mg/m2/day | Experimental | Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiation therapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7). Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51). |
|
| Treatment 2, Etoposide, 35mg/m2/day | Experimental | Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of radiation therapy to the head and spine, with boosts to the posterior fossa and to sites of metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7). Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3 courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF) SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of oral etoposide at 50 mg/m2/day given concurrently with radiotherapy followed with dose intensive adjuvant chemotherapy in children with newly diagnosed high stage medulloblastoma | It is possible that unacceptably high levels of toxicity may arise. For this reason, there is a 3-stage stopping rule designed to allow the Study Coordinator to stop this study early if it appears that the true proportion of eligible patients who suffer unacceptable levels of toxicity exceeds 10%. | End of course 1 (week 10) |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Moghrabi, MD | Hopital Sainte Justine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama | 35294-3300 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23857975 | Derived | Tarbell NJ, Friedman H, Polkinghorn WR, Yock T, Zhou T, Chen Z, Burger P, Barnes P, Kun L. High-risk medulloblastoma: a pediatric oncology group randomized trial of chemotherapy before or after radiation therapy (POG 9031). J Clin Oncol. 2013 Aug 10;31(23):2936-41. doi: 10.1200/JCO.2012.43.9984. Epub 2013 Jul 15. |
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| cisplatin | Drug |
|
|
| cyclophosphamide | Drug |
|
|
| etoposide | Drug |
|
|
| vincristine sulfate | Drug |
|
|
| radiation therapy | Radiation |
|
| MBCCOP - Gulf Coast |
| Mobile |
| Alabama |
| 36688 |
| United States |
| Arizona Cancer Center | Tucson | Arizona | 85724 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| University of California San Diego Cancer Center | La Jolla | California | 92093-0658 | United States |
| Lucile Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | United States |
| Sutter Cancer Center | Sacramento | California | 95816 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente-Southern California Permanente Medical Group | San Diego | California | 92120 | United States |
| Children's Hospital and Health Center | San Diego | California | 92123-4282 | United States |
| Naval Medical Center - San Diego | San Diego | California | 92134-3202 | United States |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | 95051-5386 | United States |
| Yale Comprehensive Cancer Center | New Haven | Connecticut | 06520-8028 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | United States |
| Shands Hospital and Clinics, University of Florida | Gainesville | Florida | 32610-100277 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Sylvester Cancer Center, University of Miami | Miami | Florida | 33136 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| Walt Disney Memorial Cancer Institute | Orlando | Florida | 32803 | United States |
| CCOP - Florida Pediatric | Tampa | Florida | 33682-7757 | United States |
| St. Mary's Hospital | West Palm Beach | Florida | 33407 | United States |
| Emory University Hospital - Atlanta | Atlanta | Georgia | 30322 | United States |
| Cancer Research Center of Hawaii | Honolulu | Hawaii | 96813 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859-5000 | United States |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| Children's Memorial Hospital, Chicago | Chicago | Illinois | 60614 | United States |
| Hope Children's Hospital | Oak Lawn | Illinois | 60453 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214-3882 | United States |
| Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| CCOP - Ochsner | New Orleans | Louisiana | 70121 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Maine Children's Cancer Program | Portland | Maine | 04101 | United States |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21231-2410 | United States |
| Boston Floating Hospital Infants and Children | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| St. John's Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216-4505 | United States |
| Keesler Medical Center - Keesler AFB | Keesler Air Force Base | Mississippi | 39534-2576 | United States |
| University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri | 65212 | United States |
| Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756-0002 | United States |
| CCOP - Northern New Jersey | Hackensack | New Jersey | 07601 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of New Mexico School of Medicine | Albuquerque | New Mexico | 87131 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
| Schneider Children's Hospital | New Hyde Park | New York | 11042 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| University of Rochester Cancer Center | Rochester | New York | 14642 | 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 |
| Mission Saint Joseph's Health System | Asheville | North Carolina | 28801 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Presbyterian Healthcare | Charlotte | North Carolina | 28233-3549 | United States |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
| East Carolina University School of Medicine | Greenville | North Carolina | 27858-4354 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157-1082 | United States |
| Oklahoma Memorial Hospital | Oklahoma City | Oklahoma | 73126-0307 | United States |
| Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma | 74136 | United States |
| CCOP - Columbia River Program | Portland | Oregon | 97213 | United States |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | United States |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134-1095 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | United States |
| Children's Hospital of Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| James H. Quillen College of Medicine | Johnson City | Tennessee | 37614-0622 | United States |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105-2794 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Simmons Cancer Center - Dallas | Dallas | Texas | 75235-9154 | United States |
| Cook Children's Medical Center - Fort Worth | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-0209 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas | 78236-5300 | United States |
| MBCCOP - South Texas Pediatric | San Antonio | Texas | 78229-3900 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78284-7811 | United States |
| Scott and White Clinic | Temple | Texas | 76508 | United States |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22046 | United States |
| Naval Medical Center, Portsmouth | Portsmouth | Virginia | 23708-2197 | United States |
| Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
| Carilion Roanoke Community Hospital | Roanoke | Virginia | 24029 | United States |
| Madigan Army Medical Center | Tacoma | Washington | 98431-5000 | United States |
| West Virginia University Medical School-Charleston | Charleston | West Virginia | 25304 | United States |
| West Virginia University Hospitals | Morgantown | West Virginia | 26506-9162 | United States |
| St. Vincent Hospital | Green Bay | Wisconsin | 54307-3508 | United States |
| Midwest Children's Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Alberta Children's Hospital | Calgary | Alberta | T2T 5C7 | Canada |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Children's Hospital | Hamilton | Ontario | L8N 3Z5 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec | H3H 1P3 | Canada |
| Hopital Sainte Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier de L'Universite Laval | Sainte-Foy | Quebec | GIV 4G2 | Canada |
| Academisch Ziekenhuis Groningen | Groningen | 9713 EZ | Netherlands |
| San Jorge Childrens Hospital | Santurce | 00912 | Puerto Rico |
| Swiss Pediatric Oncology Group Bern | Bern | CH 3010 | Switzerland |
| Clinique de Pediatrie | Geneva | 1211 | Switzerland |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D002945 | Cisplatin |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D014750 | Vincristine |
| 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 |
| 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 |
| D013812 | Therapeutics |
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