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Spots Global Cancer Trial Database for Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Claire M Mazewski

Affiliation: Children's Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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