Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as vincristine, cisplatin, lomustine, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy with chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether standard-dose radiation therapy combined with chemotherapy after surgery is more effective than reduced-dose craniospinal (head and spine) radiation therapy plus either posterior fossa (back of the brain) boost or tumor bed (site of the tumor) boost radiation therapy combined with chemotherapy in treating medulloblastoma.
PURPOSE: This randomized phase III trial is studying standard-dose radiation therapy to see how well it works compared to reduced-dose craniospinal radiation therapy AND posterior fossa boost radiation therapy to see how well it works compared to tumor bed boost radiation therapy when given together with chemotherapy in treating young patients who have undergone surgery for newly diagnosed standard-risk medulloblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: cisplatin Drug: cyclophosphamide Drug: lomustine Drug: vincristine sulfate Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial |
- Time to event as measured by the time to disease progression, disease recurrence, death from any cause, or occurrence of a second malignant neoplasm at 3 years [ Designated as safety issue: No ]
- Time to recurrence, progression, or death due to cancer at 3 years [ Designated as safety issue: No ]
- Time to death at 3 years [ Designated as safety issue: No ]
- Local Posterior Fossa (LPF) Failure as determined by tumor recurrence or progression within the tumor bed at 3 years [ Designated as safety issue: No ]
- Non-local Posterior Fossa (NLPF) Failure as determined by recurrence outside CTVboost but within CTVPF at 3 years [ Designated as safety issue: No ]
- Non-Posterior Fossa (NPF) Failure as determine by recurrence within the neuroaxis but outside of CTVPF at 3 years [ Designated as safety issue: No ]
- Post-treatment neurocognitive function as measured by Neuropsychometric battery at 3 years [ Designated as safety issue: No ]
- Post-treatment hearing loss as measure by Audiogram or brainstem auditory evoked response (BAER) at 3 years [ Designated as safety issue: No ]
- Post-treatment endocrine function (e.g., growth, sexual maturation, and need for hormone replacement) by laboratory assesment, clinical history, and exam at 3 years [ Designated as safety issue: No ]
- Quality of Life as measured by Pediatric Quality of Life Inventory (PedsQL), Behavior Assessment System for Children (BASC), Behavior Rating Inventory of Executive Function (BRIEF), and Adaptive Behavior Assessment System (ABAS) at 3 years [ Designated as safety issue: No ]
| Estimated Enrollment: | 510 |
| Study Start Date: | April 2004 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients undergo reduced-dose craniospinal radiotherapy with boost.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Active Comparator: Arm II
Patients undergo standard-dose craniospinal radiotherapy with boost.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Active Comparator: Arm III
Patients will undergo radiotherapy boost to the entire posterior fossa.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Experimental: Arm IV
Patients will undergo radiotherapy boost to the tumor bed only.
|
Radiation: radiation therapy
Given on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47 (weeks 0-6) at different doses.
|
|
Experimental: Regimen A (courses 1, 2, 4, 5, 7, and 8)
Patients receive oral lomustine and cisplatin IV over 6 hours on day 1 and vincristine IV on days 1, 8, and 15 of weeks 11, 17, 27, 33, 43, and 49.
|
Drug: cisplatin
Given IV
Drug: lomustine
Given orally
Drug: vincristine sulfate
Given IV
|
|
Experimental: Regimen B (courses 3, 6, and 9)
Patients receive cyclophosphamide IV over 1 hour on days 1 and 2 and vincristine IV on days 1 and 8 of weeks 23, 39, and 55.
|
Drug: cyclophosphamide
Given IV
Drug: vincristine sulfate
Given IV
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed medulloblastoma located in the posterior fossa
- Standard-risk disease
Minimal volume, non-disseminated disease, defined by the following:
- Residual tumor ≤ 1.5 cm^2 confirmed by MRI with contrast imaging within 21 days after surgery
No metastatic disease in the head, spine, or cerebrospinal fluid (CSF) confirmed by both of the following:
- Enhanced MRI of the spine within 5 days before surgery OR within 28 days after surgery
- Negative cytological examination of CSF after surgery, but before study enrollment
- Brain stem involvement allowed
PATIENT CHARACTERISTICS:
Age
- 3 to 21 at diagnosis
Performance status
- Karnofsky 50-100% (> 16 years of age) OR
- Lansky 30-100% (≤ 16 years of age)
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
- Hemoglobin > 10 g/dL (transfusions allowed)
Hepatic
- Bilirubin < 1.5 times upper limit of normal (ULN)
- AST or ALT < 1.5 times ULN
Renal
- Creatinine clearance OR radioisotope glomerular filtration rate ≥ 70 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Prior corticosteroids allowed
Radiotherapy
- No prior radiotherapy
Surgery
- See Disease Characteristics
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Children's Hospital of Alabama at University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Joseph G. Pressey 205-939-9285 | |
| United States, Arizona | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016-7710 | |
| Contact: Jessica Boklan 602-546-0920 | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
| Tucson, Arizona, United States, 85724-5024 | |
| Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |
| United States, California | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Amanda M. Termuhlen 562-933-8605 | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-2529 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048-1865 | |
| Contact: Fataneh (Fae) Majlessipour 310-423-4423 | |
| Southern California Permanente Medical Group | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Robert M. Cooper 323-783-5307 | |
| Children's Hospital Central California | Recruiting |
| Madera, California, United States, 93638-8762 | |
| Contact: Vonda L. Crouse 559-353-5480 | |
| Children's Hospital and Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600 | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Violet Shen 714-532-8636 | |
| Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
| Palo Alto, California, United States, 95798 | |
| Contact: Neyssa M. Marina 650-723-5535 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| Kaiser Permanente Medical Center - Oakland | Recruiting |
| Sacramento, California, United States, 95661 | |
| Contact: Steven K. Bergstrom 510-752-6592 | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123-4282 | |
| Contact: Clinical Trials Office - Rady Children's Hospital - San Diego 858-966-5934 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| United States, Colorado | |
| Children's Hospital Colorado Center for Cancer and Blood Disorders | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly W. Maloney 720-777-6673 | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Clinical Trials Office - Connecticut Children's Medical Center 860-545-9967 | |
| Yale Cancer Center | Recruiting |
| New Haven, Connecticut, United States, 06520-8028 | |
| Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| United States, Florida | |
| Broward General Medical Center Cancer Center | Recruiting |
| Fort Lauderdale, Florida, United States, 33316 | |
| Contact: Clinical Trials Office - Broward General Medical Center Cancer 954-355-5346 | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
| University of Florida Shands Cancer Center | Recruiting |
| Gainesville, Florida, United States, 32610-0232 | |
| Contact: Clinical Trials Office - University of Florida Shands Cancer C 888-254-7581 | |
| Memorial Cancer Institute at Memorial Regional Hospital | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Clinical Trials Office - Memorial Cancer Institute 954-985-3443 | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |
| Miami Children's Hospital | Recruiting |
| Miami, Florida, United States, 33155 | |
| Contact: Enrique A. Escalon 305-662-8360x4960 | |
| Nemours Children's Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Ramamoorthy Nagasubramanian 407-650-7230 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| M.D. Anderson Cancer Center at Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Vincent F. Giusti 321-841-8588 | |
| Nemours Children's Clinic - Pensacola | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Jeffrey H. Schwartz 850-505-4790 | |
| All Children's Hospital | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: Gregory A. Hale 727-767-4176 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123 | |
| United States, Georgia | |
| AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Todd M. Cooper 404-785-1838 | |
| MBCCOP - Medical College of Georgia Cancer Center | Recruiting |
| Augusta, Georgia, United States, 30912-3730 | |
| Contact: Colleen H. McDonough 706-721-3626 | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403-3089 | |
| Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979 | |
| Tripler Army Medical Center | Recruiting |
| Tripler AMC, Hawaii, United States, 96859-5000 | |
| Contact: Della L. Howell 210-916-7727 | |
| United States, Idaho | |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Recruiting |
| Boise, Idaho, United States, 83712-6297 | |
| Contact: Eugenia Chang 208-381-2731 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Stewart Goldman 312-227-4844 | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Clinical Trials Office - Cardinal Bernardin Cancer Center 708-226-4357 | |
| Keyser Family Cancer Center at Advocate Hope Children's Hospital | Recruiting |
| Oak Lawn, Illinois, United States, 60453 | |
| Contact: Ammar Hayani 708-684-4094 | |
| Advocate Lutheran General Cancer Care Center | Recruiting |
| Park Ridge, Illinois, United States, 60068-1174 | |
| Contact: Clinical Trials Office - Advocate Lutheran General Cancer Care 847-384-3621 | |
| Saint Jude Midwest Affiliate | Recruiting |
| Peoria, Illinois, United States, 61603 | |
| Contact: Pedro A. De Alarcon 309-655-4242 | |
| Simmons Cooper Cancer Institute | Recruiting |
| Springfield, Illinois, United States, 62794-9677 | |
| Contact: Clinical Trials Office - Simmons Cooper Cancer Institute 217-545-7929 | |
| United States, Indiana | |
| Riley's Children Cancer Center at Riley Hospital for Children | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: James M. Croop 317-944-8784 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Iowa | |
| Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729 | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Kentucky | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40232 | |
| Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org | |
| United States, Louisiana | |
| Tulane Cancer Center Office of Clinical Research | Recruiting |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121 | |
| Children's Hospital of New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Clinical Trials Office - Children's Hospital of New Orleans 504-894-5377 | |
| MBCCOP - LSU Health Sciences Center | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Contact Person 504-568-5151 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medical Center | Recruiting |
| Bangor, Maine, United States, 04401 | |
| Contact: Clinical Trials Office - CancerCare of Maine 207-973-4274 | |
| Maine Children's Cancer Program at Barbara Bush Children's Hospital | Recruiting |
| Scarborough, Maine, United States, 04074-9308 | |
| Contact: Eric C. Larsen 207-396-7565 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Clinical Trials Office - Greenebaum Cancer Center at Universit 800-888-8823 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| National Naval Medical Center | Recruiting |
| Bethesda, Maryland, United States, 20889-5600 | |
| Contact: Della L. Howell 210-916-7727 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 2115 | |
| Contact: Carlos Rodriguez-Galindo 617-632-4580 | |
| Floating Hospital for Children at Tufts - New England Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Johannes E.A. Wolff 617-636-5535 | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
| United States, Michigan | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Helen DeVos Children's Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503 | |
| Contact: Clinical Trials Office - Helen DeVos Children's Hospital 616-391-3050 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| Bronson Methodist Hospital | Recruiting |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Contact: Jeffrey S. Lobel 269-341-6350 | |
| Breslin Cancer Center at Ingham Regional Medical Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio 517-334-2765 | |
| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193 | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| Children's Hospitals and Clinics of Minnesota - St. Paul | Recruiting |
| St. Paul, Minnesota, United States, 55102-2392 | |
| Contact: Contact Person 612-220-6000 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Gail C. Megason 601-984-5220 | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine L. Hetherington 816-234-3265 | |
| Cardinal Glennon Children's Hospital | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| Contact: William S. Ferguson 314-577-5638 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 314-454-2041 | |
| United States, Nebraska | |
| Children's Hospital | Recruiting |
| Omaha, Nebraska, United States, 68114-4113 | |
| Contact: Minnie Abromowitch 402-955-3950 | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6805 | |
| Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89109-2306 | |
| Contact: Jonathan Bernstein 702-732-1493 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 | |
| Saint Peter's University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Stanley Calderwood 732-745-6674 | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136 | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Paterson, New Jersey, United States, 07503 | |
| Contact: Mary A. Bonilla 973-754-3349 | |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Recruiting |
| Summit, New Jersey, United States, 07901 | |
| Contact: Steven L. Halpern 973-971-6720 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Albany Medical Center Hospital | Recruiting |
| Albany, New York, United States, 12208-3419 | |
| Contact: Vikramjit S. Kanwar 518-262-5513x25517 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Mark E. Weinblatt 516-663-9400 | |
| Schneider Children's Hospital | Recruiting |
| New Hyde Park, New York, United States, 11040 | |
| Contact: Arlene S. Redner 718-470-3460 | |
| NYU Cancer Institute at New York University Medical Center | Recruiting |
| New York, New York, United States, 10016 | |
| Contact: Linda Granowetter 212-263-8400 | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Jeffrey R. Andolina 585-275-2981 | |
| Stony Brook University Cancer Center | Recruiting |
| Stony Brook, New York, United States, 11794-9446 | |
| Contact: Clinical Trials Office - Stony Brook University Cancer Center 800-862-2215 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Mehmet F. Ozkaynak 914-493-7997 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, North Dakota | |
| CCOP - MeritCare Hospital | Recruiting |
| Fargo, North Dakota, United States, 58122 | |
| Contact: Nathan L. Kobrinsky 701-234-7544 | |
| United States, Ohio | |
| Akron Children's Hospital | Recruiting |
| Akron, Ohio, United States, 44308-1062 | |
| Contact: Clinical Trials Office - Akron Children's Hospital 330-543-3193 | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106-5000 | |
| Contact: Yousif (Joe) H. Matloub 216-844-3345 | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Laura T. Martin 614-722-3582 | |
| Dayton Children's - Dayton | Recruiting |
| Dayton, Ohio, United States, 45404-1815 | |
| Contact: Emmett H. Broxson 937-641-3111 | |
| Mercy Children's Hospital | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Rama Jasty 419-251-8215 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| Tod Children's Hospital | Recruiting |
| Youngstown, Ohio, United States, 44501 | |
| Contact: Clinical Trials Office - Tod Children's Hospital 330-884-3955 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Legacy Emanuel Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Children's Hospital 503-413-2560 | |
| United States, Pennsylvania | |
| Lehigh Valley Hospital - Muhlenberg | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Philip M. Monteleone 484-884-3333 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Penn State Children's Hospital | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Lisa M. McGregor 717-531-6012 | |
| St. Christopher's Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Contact: Clinical Trials Office - St. Christopher's Hospital for Childr 215-427-8991 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321 | |
| Palmetto Health South Carolina Cancer Center | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680 | |
| BI-LO Charities Children's Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Nichole L. Bryant 864-455-8898 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| T.C. Thompson Children's Hospital | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Manoo G. Bhakta 423-778-7289 | |
| East Tennessee Children's Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37916 | |
| Contact: Ray C. Pais 865-541-8266 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Texas | |
| Texas Tech University Health Sciences Center School of Medicine - Amarillo | Recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Osvaldo Regueira 806-354-5434x282 | |
| Dell Children's Medical Center of Central Texas | Recruiting |
| Austin, Texas, United States, 78723 | |
| Contact: Clinical Trials Office - Dell Children's Medical Center of Cen 512-324-8022 | |
| Driscoll Children's Hospital | Recruiting |
| Corpus Christi, Texas, United States, 78411 | |
| Contact: Clinical Trials Office - Driscoll Children's Hospital 361-694-5311 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| Medical City Dallas Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Carl Lenarsky 972-566-6647x4439 | |
| Brooke Army Medical Center | Recruiting |
| Fort Sam Houston, Texas, United States, 78234-6200 | |
| Contact: Clinical Trials Office - Brooke Army Medical Center 210-916-4837 | |
| Cook Children's Medical Center - Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103 | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Patrick A. Thompson 832-824-4029 | |
| Covenant Children's Hospital | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Latha Prasannan 806-725-4840 | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229-3993 | |
| Contact: Jaime Estrada 210-575-7268 | |
| University of Texas Health Science Center at San Antonio | Recruiting |
| San Antonio, Texas, United States, 78207 | |
| Contact: Anne-Marie R. Langevin 210-567-7477 | |
| CCOP - Scott and White Hospital | Recruiting |
| Temple, Texas, United States, 76508 | |
| Contact: Guy H. Grayson 254-724-2006 | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Virginia | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042-3300 | |
| Contact: Clinical Trials Office - Inova Fairfax Hospital 703-208-6650 | |
| Children's Hospital of The King's Daughters | Recruiting |
| Norfolk, Virginia, United States, 23507-1971 | |
| Contact: Eric J. Lowe 757-668-7243 | |
| Naval Medical Center - Portsmouth | Recruiting |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Contact: Clinical Trials Office - Naval Medical Center - Portsmouth 757-953-5939 | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| Carilion Medical Center for Children at Roanoke Community Hospital | Recruiting |
| Roanoke, Virginia, United States, 24014 | |
| Contact: Mandy M. Atkinson 540-981-7376 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Julie R. Park 206-987-2106 | |
| Deaconess Medical Center | Recruiting |
| Spokane, Washington, United States, 99210-0248 | |
| Contact: Contact Person 509-473-5800 | |
| Providence Cancer Center at Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99220-2555 | |
| Contact: Judy L. Felgenhauer 509-474-2777 | |
| Madigan Army Medical Center - Tacoma | Recruiting |
| Tacoma, Washington, United States, 98431 | |
| Contact: Della L. Howell 210-916-7727 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | Recruiting |
| Charleston, West Virginia, United States, 25302 | |
| Contact: Allen R. Chauvenet 304-388-1552 | |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Recruiting |
| Huntington, West Virginia, United States, 25701 | |
| Contact: Oncology Research Supervisor 304-399-6617 | |
| United States, Wisconsin | |
| St. Vincent Hospital Regional Cancer Center | Recruiting |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
| Gundersen Lutheran Center for Cancer and Blood | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center 608-775-2385 cancerctr@gundluth.org | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael E. Kelly 414-456-4170 | |
| Australia, South Australia | |
| Women's and Children's Hospital | Recruiting |
| North Adelaide, South Australia, Australia, 5006 | |
| Contact: Maria L. Kirby 61881617411 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine H. Cole 011-6189340-8238 | |
| Canada, Alberta | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Contact: Sunil Jayantilal` S. Desai 780-248-5530 | |
| Canada, British Columbia | |
| Children's and Women's Hospital of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Caron Strahlendorf 604-875-3576 | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Rochelle A. Yanofsky 204-787-4163 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Contact: Lisa Anne B. Goodyear 709-777-4303 | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3J 3G9 | |
| Contact: Margaret C. Yhap 902-470-8778 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Contact: Carol Portwine 905-521-2100x73464 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Contact: Mariana P. Silva 613-5496666x3833 | |
| Children's Hospital of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Anne E.L. Cairney 519-685-8494 | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Jacqueline M.L. Halton 613-737-7600x2370 | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Sylvain Baruchel 416-813-7795 | |
| Canada, Quebec | |
| Montreal Children's Hospital at McGill University Health Center | Recruiting |
| Montreal, Quebec, Canada, H3H 1P3 | |
| Contact: Sharon B. Abish 514-412-4400x22219 | |
| Hopital Sainte Justine | Recruiting |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Contact: Yvan Samson 514-345-4931x2790 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Christopher Mpofu 306-655-2744 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | Recruiting |
| Quebec, Canada, G1V 4G2 | |
| Contact: Bruno Michon 418-656-4141X47191 | |
| Netherlands | |
| Dutch Childhood Oncology Group | Recruiting |
| The Hague, Netherlands, 2504 AM | |
| Contact: Hester de Groot-Kruseman 31070367-4545 | |
| New Zealand | |
| Starship Children's Health | Recruiting |
| Auckland, New Zealand, 1 | |
| Contact: Lochie R. Teague 649-307-4949x22423 | |
| Christchurch Hospital | Recruiting |
| Christchurch, New Zealand, 8140 | |
| Contact: Michael J. Sullivan +64-33640744 | |
| Wellington Children's Hospital | Recruiting |
| Wellington, New Zealand, 6002 | |
| Contact: Contact Person 64-4-918-5091 | |
| Puerto Rico | |
| San Jorge Children's Hospital | Recruiting |
| Santurce, Puerto Rico, 00912 | |
| Contact: Luis A. Clavell 787-728-1575 | |
| Switzerland | |
| Swiss Pediatric Oncology Group Bern | Recruiting |
| Bern, Switzerland, 3010 | |
| Contact: Roland A. Ammann 41316329372 | |
| Swiss Pediatric Oncology Group Geneva | Recruiting |
| Geneva, Switzerland, 1205 | |
| Contact: Marc Ansari +41795533626 | |
| Swiss Pediatric Oncology Group Lausanne | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Maja Beck Popovic 41213141111x43567 | |
| Study Chair: | Jeff M. Michalski, MD | Washington University Siteman Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gregory H. Reaman, Children's Oncology Group - Group Chair Office |
| ClinicalTrials.gov Identifier: | NCT00085735 History of Changes |
| Other Study ID Numbers: | CDR0000365506, COG-ACNS0331 |
| Study First Received: | June 14, 2004 |
| Last Updated: | November 22, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
untreated childhood medulloblastoma |
Additional relevant MeSH terms:
|
Medulloblastoma Nervous System Neoplasms Central Nervous System Neoplasms Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neuroectodermal Tumors, Primitive Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Cisplatin |
Cyclophosphamide Lomustine Vincristine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 16, 2013