NCT00336024CompletedPhase 3
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old With Intensive Induction Chemotherapy With Methotrexate Followed by Consolidation With Stem Cell Rescue vs. the Same Therapy Without Methotrexate
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating young patients with newly diagnosed supratentorial primitive neuroectodermal tumors or high-risk medulloblastoma when given before additional intense chemotherapy followed by peripheral blood stem cell rescue. It is not yet known which combination chemotherapy regimen is more effective when given before a peripheral stem cell transplant in treating supratentorial primitive neuroectodermal tumors or medulloblastoma.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 91 (actual)
- First submitted
- 8 Jun 2006
- Start date
- 22 Oct 2007
- Primary completion date
- 31 Dec 2016
- Lead sponsor
- Children's Oncology Group
- Diseases
- Childhood cancers
- NCT number
- NCT00336024
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 91
- From 22 Oct 2007 to the primary completion date, 31 Dec 2016
- 145 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- High-risk medulloblastoma defined by any of the following:
- \> 1.5 cm\^2 residual disease for any medulloblastoma histology, or
- Lumbar cerebral spinal fluid (CSF) cytology positive for tumor cells by analysis of fluid collected either before definitive surgery or at least 10 days after definitive surgery unless contraindicated, or
- Magnetic resonance imaging (MRI) evidence of M2 or M3 metastatic disease, or
- M4 disease
- Supratentorial primitive neuroectodermal tumor (PNET) (any M-stage) will be eligible for study entry
- Children less than 8 months of age at the time of definitive surgery with or without measurable radiographic residual tumor with M0 stage medulloblastoma will be eligible for study entry
- Patients with anaplastic medulloblastoma are eligible regardless of M-stage or residual tumor
- Patients with M0 classic, non-desmoplastic medulloblastoma (R1) with radiographically measurable residual disease \< 1.5 cm\^2 are eligible
- Cranial MRI (with and without gadolinium) must be done pre-operatively; post-operatively, cranial MRI (with and without gadolinium) must be done, preferably within 48 hours of surgery; entire spinal MRI must be obtained either pre-operatively (with gadolinium) or post-operatively (at least 10 days following surgery) prior to study enrollment (with and without gadolinium); patients with MRI evidence of spinal disease are eligible for this study
- Evaluation of lumbar CSF cytology (cytospin preparation for microscopic evaluation) must be performed either pre-operatively or at least 10 days after definitive surgery unless contraindicated
- Patient must have a life expectancy \> 8 weeks
- Patient must have received no prior radiation therapy or chemotherapy other than corticosteroids; corticosteroids are allowable for all patients
- Creatinine clearance or radioisotope glomerular filtration rate \>= 60 mL/min
- Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age, and
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamic pyruvic transaminase (SGPT) (alanine transaminase \[ALT\]) \< 2 x ULN for age
- Shortening fraction \>= 27% by echocardiogram, or
- Ejection fraction \>= 47% by radionuclide angiogram
- No evidence of dyspnea at rest
- Pulse oximetry \> 94% on room air
- Peripheral absolute neutrophil count (ANC) \> 1,000/uL
- Platelet count \> 100,000/uL (transfusion independent)
- Hemoglobin greater than 8 g/dL (may have received red blood cell \[RBC\] transfusions allowed)
- Hold trimethoprim/sulfamethoxazole (Bactrim) on the day of high-dose methotrexate (HDMTX) infusion and continue to hold until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M)
- Avoid probenecid, penicillins, cephalosporins, aspirin, proton pump inhibitors and nonsteroidal anti-inflammatory drug (NSAIDS) on the day of methotrexate and continue until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M) as renal excretion of methotrexate is inhibited by these agents
- Avoid IV contrast media, urinary acidifiers, phenytoin, and fosphenytoin on the day of methotrexate and until the methotrexate level is less than 0.1 micromolar (1 x 10-7 M)
- Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and carbamazepine) should be avoided
- Clinically significant drug interactions have been reported when using vincristine with strong cytochrome P450 (CYP450) family 3 subfamily A member 4 (3A4) inhibitors and inducers; selected strong inhibitors of cytochrome P450 3A4 include azole antifungals, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort; the use of these drugs should be avoided with vincristine
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Age in the registry: - to 2 years · Sex: All · Does not accept healthy volunteers
Sites (145)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Children's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Princess Margaret Hospital for Children Coordinator of this site? Confirm its status | Perth | Australia | Unknown status |
| Sydney Children's Hospital Coordinator of this site? Confirm its status | Randwick | Australia | Unknown status |
| The Children's Hospital at Westmead Coordinator of this site? Confirm its status | Westmead | Australia | Unknown status |
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| IWK Health Centre Coordinator of this site? Confirm its status | Halifax | Canada | Unknown status |
| McMaster Children's Hospital at Hamilton Health Sciences Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Kingston Health Sciences Centre Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Centre Hospitalier Universitaire Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Montreal Children's Hospital of the MUHC Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Children'S Hospital Of Eastern Ontario Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| British Columbia Children's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| CancerCare Manitoba Coordinator of this site? Confirm its status | Winnipeg | Canada | Unknown status |
| San Jorge Children's Hospital Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| University of New Mexico Cancer Center Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Texas Tech University Health Sciences Center-Amarillo Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| C S Mott Children's Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Johns Hopkins University/Sidney Kimmel Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Eastern Maine Medical Center Coordinator of this site? Confirm its status | Bangor | United States | Unknown status |
| Walter Reed National Military Medical Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| University of Alabama at Birmingham Cancer Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Children's Hospital of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Saint Luke's Cancer Institute - Boise Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Tufts Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| University of Vermont and State Agricultural College Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Medical University of South Carolina Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Carolinas Medical Center/Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Novant Health Presbyterian Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Lurie Children's Hospital-Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rainbow Babies and Childrens Hospital Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Prisma Health Richland Hospital Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Driscoll Children's Hospital Coordinator of this site? Confirm its status | Corpus Christi | United States | Unknown status |
| Medical City Dallas Hospital Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Geisinger Medical Center Coordinator of this site? Confirm its status | Danville | United States | Unknown status |
| Dayton Children's Hospital Coordinator of this site? Confirm its status | Dayton | United States | Unknown status |
| Kaiser Permanente Downey Medical Center Coordinator of this site? Confirm its status | Downey | United States | Unknown status |
| Michigan State University Coordinator of this site? Confirm its status | East Lansing | United States | Unknown status |
| Inova Fairfax Hospital Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
| Sanford Broadway Medical Center Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Broward Health Medical Center Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Golisano Children's Hospital of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Lee Memorial Health System Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Cook Children's Medical Center Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| University of Florida Health Science Center - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| BI-LO Charities Children's Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Greenville Cancer Treatment Center Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Connecticut Children's Medical Center Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| University of Hawaii Cancer Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Ascension Saint Vincent Indianapolis Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa/Holden Comprehensive Cancer Center Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| Nemours Children's Clinic-Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Kalamazoo Center for Medical Studies Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Bronson Methodist Hospital Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Children's Mercy Hospitals and Clinics Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| East Tennessee Childrens Hospital Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Nevada Cancer Research Foundation NCORP Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Alliance for Childhood Diseases/Cure 4 the Kids Foundation Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| University of Kentucky/Markey Cancer Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Loma Linda University Medical Center Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Miller Children's and Women's Hospital Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Norton Children's Hospital Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Covenant Children's Hospital Coordinator of this site? Confirm its status | Lubbock | United States | Unknown status |
| Valley Children's Hospital Coordinator of this site? Confirm its status | Madera | United States | Unknown status |
| Marshfield Medical Center-Marshfield Coordinator of this site? Confirm its status | Marshfield | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Nicklaus Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| NYU Langone Hospital - Long Island Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Children's Hospitals and Clinics of Minnesota - Minneapolis Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Morristown Medical Center Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Tulane University School of Medicine Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Advocate Children's Hospital-Oak Lawn Coordinator of this site? Confirm its status | Oak Lawn | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Children's Hospital of Orange County Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Nemours Children's Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Nemours Children's Clinic - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Arnold Palmer Hospital for Children Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Orlando Health Cancer Institute Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Saint Joseph's Regional Medical Center Coordinator of this site? Confirm its status | Paterson | United States | Unknown status |
| Nemours Children's Clinic - Pensacola Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Saint Christopher's Hospital for Children Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Phoenix Childrens Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Children's Hospital of Pittsburgh of UPMC Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Legacy Emanuel Children's Hospital Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Oregon Health and Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Legacy Emanuel Hospital and Health Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Naval Medical Center - Portsmouth Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California Davis Comprehensive Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Sutter Medical Center Sacramento Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Primary Children's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Methodist Children's Hospital of South Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Rady Children's Hospital - San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| UCSF Medical Center-Parnassus Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Sanford USD Medical Center - Sioux Falls Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Providence Sacred Heart Medical Center and Children's Hospital Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| Cardinal Glennon Children's Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Stony Brook University Medical Center Coordinator of this site? Confirm its status | Stony Brook | United States | Unknown status |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Overlook Hospital Coordinator of this site? Confirm its status | Summit | United States | Unknown status |
| Mary Bridge Children's Hospital and Health Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Saint Joseph's Hospital/Children's Hospital-Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Montefiore Medical Center - Moses Campus Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| Mercy Children's Hospital Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| New York Medical College Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Saint Mary's Medical Center Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Alfred I duPont Hospital for Children Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.