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Brief Title: Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
Official Title: 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
Study ID: NCT00336024
Brief Summary: 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.
Detailed Description: PRIMARY OBJECTIVES: I. To determine if treatment of infants with high risk primitive neuroectodermal tumors (PNET) central nervous system (CNS) tumors with intensive chemotherapy plus high-dose methotrexate and peripheral blood stem cell rescue results in a higher complete response rate then the same regimen without methotrexate. SECONDARY OBJECTIVES: I. To determine whether biologic characterization of these tumors will refine therapeutic stratification separating atypical teratoid rhabdoid tumors (AT/RT) from primitive neuroectodermal tumors (PNETs) and possibly identifying other markers of value for stratification within the group of PNETs. II. To determine if event free survival (EFS) and patterns of failure differ between the methotrexate arm versus the arm without methotrexate. III. To compare the acute, chronic and late effects of these two very intensive regimens, especially as to the tolerance of the same consolidation regimen following the differing induction regimens. IV. To compare the gastrointestinal and nutritional toxicities of these intense regimens. V. To describe and compare the quality of life outcomes and neuropsychological effects of these intense systemic therapies. OUTLINE: Patients are randomized to 1 of 2 treatment arms INDUCTION THERAPY: ARM I: Patients receive vincristine IV over 1 minute on days 1, 8, and 15; etoposide IV over 1 hour on days 1-3; cyclophosphamide IV over 1 hour on days 1 and 2; cisplatin IV over 6 hours on day 3; and filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive vincristine IV over 1 minute on days 1, 8, and 15; high-dose methotrexate IV over 4 hours on day 1; and leucovorin calcium IV or orally (PO) every 6 hours beginning on day 2 and continuing until methotrexate levels are in a safe range. Once methotrexate levels are in a safe range, patients then receive etoposide IV over 1 hour on approximately days 4, 5, and 6, cyclophosphamide IV over 1 hour on approximately days 4 and 5, and cisplatin IV over 6 hours on approximately day 6. Patients also receive G-CSF IV or SC beginning 24 hours after the completion of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. In both arms, patients with stable disease or partial response after induction therapy proceed to second-look surgery followed by consolidation therapy. Patients with a complete response after induction therapy proceed directly to consolidation therapy. CONSOLIDATION THERAPY: Beginning no more than 6 weeks after completion of induction therapy, patients receive consolidation therapy comprising carboplatin IV over 2 hours and thiotepa IV over 2 hours on days 1 and 2 and G-CSF IV or SC beginning on day 5 and continuing until blood counts recover. Patients also receive autologous peripheral blood stem cells (PBSC) IV on day 4. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up periodically for 4 years and then annually thereafter.
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Children's Hospital of Alabama, Birmingham, Alabama, United States
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Phoenix Childrens Hospital, Phoenix, Arizona, United States
Arkansas Children's Hospital, Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center, Downey, California, United States
Loma Linda University Medical Center, Loma Linda, California, United States
Miller Children's and Women's Hospital Long Beach, Long Beach, California, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Cedars Sinai Medical Center, Los Angeles, California, United States
Valley Children's Hospital, Madera, California, United States
Children's Hospital of Orange County, Orange, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Rady Children's Hospital - San Diego, San Diego, California, United States
UCSF Medical Center-Parnassus, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I duPont Hospital for Children, Wilmington, Delaware, United States
Children's National Medical Center, Washington, District of Columbia, United States
Broward Health Medical Center, Fort Lauderdale, Florida, United States
Lee Memorial Health System, Fort Myers, Florida, United States
Golisano Children's Hospital of Southwest Florida, Fort Myers, Florida, United States
University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital, Hollywood, Florida, United States
Nemours Children's Clinic-Jacksonville, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Nicklaus Children's Hospital, Miami, Florida, United States
AdventHealth Orlando, Orlando, Florida, United States
Arnold Palmer Hospital for Children, Orlando, Florida, United States
Nemours Children's Clinic - Orlando, Orlando, Florida, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Nemours Children's Hospital, Orlando, Florida, United States
Nemours Children's Clinic - Pensacola, Pensacola, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
Saint Joseph's Hospital/Children's Hospital-Tampa, Tampa, Florida, United States
Saint Mary's Hospital, West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Egleston, Atlanta, Georgia, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Advocate Children's Hospital-Oak Lawn, Oak Lawn, Illinois, United States
Ascension Saint Vincent Indianapolis Hospital, Indianapolis, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States
Norton Children's Hospital, Louisville, Kentucky, United States
Tulane University Health Sciences Center, New Orleans, Louisiana, United States
Eastern Maine Medical Center, Bangor, Maine, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Tufts Children's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
C S Mott Children's Hospital, Ann Arbor, Michigan, United States
Michigan State University Clinical Center, East Lansing, Michigan, United States
Helen DeVos Children's Hospital at Spectrum Health, Grand Rapids, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
Kalamazoo Center for Medical Studies, Kalamazoo, Michigan, United States
Children's Hospitals and Clinics of Minnesota - Minneapolis, Minneapolis, Minnesota, United States
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
Cardinal Glennon Children's Medical Center, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation, Las Vegas, Nevada, United States
Nevada Cancer Research Foundation NCORP, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Morristown Medical Center, Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center, Newark, New Jersey, United States
Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States
Overlook Hospital, Summit, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
NYU Winthrop Hospital, Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
New York Medical College, Valhalla, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Childrens Hospital, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Dayton Children's Hospital, Dayton, Ohio, United States
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital, Toledo, Ohio, United States
Mercy Children's Hospital, Toledo, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Legacy Emanuel Children's Hospital, Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children, Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Prisma Health Richland Hospital, Columbia, South Carolina, United States
BI-LO Charities Children's Cancer Center, Greenville, South Carolina, United States
Greenville Cancer Treatment Center, Greenville, South Carolina, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
East Tennessee Childrens Hospital, Knoxville, Tennessee, United States
Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center-Amarillo, Amarillo, Texas, United States
Driscoll Children's Hospital, Corpus Christi, Texas, United States
Medical City Dallas Hospital, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Covenant Children's Hospital, Lubbock, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Primary Children's Hospital, Salt Lake City, Utah, United States
University of Vermont and State Agricultural College, Burlington, Vermont, United States
Inova Fairfax Hospital, Falls Church, Virginia, United States
Naval Medical Center - Portsmouth, Portsmouth, Virginia, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Seattle Children's Hospital, Seattle, Washington, United States
Providence Sacred Heart Medical Center and Children's Hospital, Spokane, Washington, United States
Mary Bridge Children's Hospital and Health Center, Tacoma, Washington, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Sydney Children's Hospital, Randwick, New South Wales, Australia
The Children's Hospital at Westmead, Westmead, New South Wales, Australia
Royal Children's Hospital, Parkville, Victoria, Australia
Princess Margaret Hospital for Children, Perth, Western Australia, Australia
Alberta Children's Hospital, Calgary, Alberta, Canada
British Columbia Children's Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
IWK Health Centre, Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada
Hospital for Sick Children, Toronto, Ontario, Canada
The Montreal Children's Hospital of the MUHC, Montreal, Quebec, Canada
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec, , Canada
San Jorge Children's Hospital, San Juan, , Puerto Rico
Name: Claire M Mazewski
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR