Childhood Atypical Teratoid/Rhabdoid Tumor Clinical Trial
Official title:
Treatment of Atypical Teratoid/Rhabdoid Tumors (AT/RT) of the Central Nervous System With Surgery, Intensive Chemotherapy, and 3-D Conformal Radiation
Verified date | April 2024 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This phase III trial studies the side effects of combination chemotherapy, 3-dimensional conformal radiation therapy, and an autologous peripheral blood stem cell transplant, and to see how well they work in treating young patients with atypical teratoid/rhabdoid tumor of the central nervous system. Giving high-dose chemotherapy before an autologous peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy or radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy or radiation therapy.
Status | Completed |
Enrollment | 70 |
Est. completion date | March 31, 2024 |
Est. primary completion date | September 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 21 Years |
Eligibility | Inclusion Criteria: - Diagnosis of CNS atypical teratoid/rhabdoid tumor (AT/RT) or tumors that have a mutation of the INI1 gene (even if the tumor does not have the usual histologic characteristics of AT/RT) - Patients with extra neural metastasis (M4) or renal rhabdoid tumors are not eligible - Patients with MRI evidence of spinal disease are eligible - Must have undergone definitive surgery in the past 31 days - 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 or 10-28 days after surgery - Entire spinal MRI must be obtained either pre-operatively (with gadolinium) or post-operatively (10-28 days after surgery), prior to study enrollment (with and without gadolinium) - Life expectancy > 8 weeks - ANC > 1,000/uL - Platelet count > 100,000/uL (transfusion independent) - Hemoglobin > 8 g/dL (RBC transfusions allowed) - Creatinine clearance (minimum of 12-24 hour urine collection) or radioisotope GFR >= 60 mL/min - Total bilirubin =< 1.5 times upper limit of normal (ULN) for age - AST and ALT < 2 times ULN for age - Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 47% by radionuclide angiogram - No evidence of dyspnea at rest - Pulse oximetry > 94% on room air - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior radiotherapy or chemotherapy except for the following: - Patients enrolled on protocol ACNS0334 whose tumors demonstrate the INI1 gene mutation are eligible to transfer to this study even if they have received one course of induction therapy (these patients must be re-consented to treatment and restaged) - Prior corticosteroids allowed |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Children's Hospital | Parkville | Victoria |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | University of New Mexico Cancer Center | Albuquerque | New Mexico |
United States | Mission Hospital | Asheville | North Carolina |
United States | Children's Healthcare of Atlanta - Egleston | Atlanta | Georgia |
United States | Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland |
United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | University of Alabama at Birmingham Cancer Center | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center - Moses Campus | Bronx | New York |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University Charleston Division | Charleston | West Virginia |
United States | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina |
United States | Lurie Children's Hospital-Chicago | Chicago | Illinois |
United States | University of Chicago Comprehensive Cancer Center | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Rainbow Babies and Childrens Hospital | Cleveland | Ohio |
United States | Prisma Health Richland Hospital | Columbia | South Carolina |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Dayton Children's Hospital | Dayton | Ohio |
United States | Wayne State University/Karmanos Cancer Institute | Detroit | Michigan |
United States | Kaiser Permanente Downey Medical Center | Downey | California |
United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
United States | Lee Memorial Health System | Fort Myers | Florida |
United States | Cook Children's Medical Center | Fort Worth | Texas |
United States | University of Florida Health Science Center - Gainesville | Gainesville | Florida |
United States | BI-LO Charities Children's Cancer Center | Greenville | South Carolina |
United States | Greenville Cancer Treatment Center | Greenville | South Carolina |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Connecticut Children's Medical Center | Hartford | Connecticut |
United States | Penn State Children's Hospital | Hershey | Pennsylvania |
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
United States | Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic-Jacksonville | Jacksonville | Florida |
United States | Children's Mercy Hospitals and Clinics | Kansas City | Missouri |
United States | East Tennessee Childrens Hospital | Knoxville | Tennessee |
United States | University of Kentucky/Markey Cancer Center | Lexington | Kentucky |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
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 | Norton Children's Hospital | Louisville | Kentucky |
United States | Valley Children's Hospital | Madera | California |
United States | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida |
United States | Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | Children's Hospital New Orleans | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York |
United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
United States | Children's Hospital and Medical Center of Omaha | Omaha | Nebraska |
United States | Children's Hospital of Orange County | Orange | California |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Nemours Children's Clinic - Orlando | Orlando | Florida |
United States | Orlando Health Cancer Institute | Orlando | Florida |
United States | Saint Joseph's Regional Medical Center | Paterson | New Jersey |
United States | Nemours Children's Clinic - Pensacola | Pensacola | Florida |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
United States | University of Rochester | Rochester | New York |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Johns Hopkins All Children's Hospital | Saint Petersburg | Florida |
United States | Primary Children's Hospital | Salt Lake City | Utah |
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 | Rady Children's Hospital - San Diego | San Diego | California |
United States | UCSF Medical Center-Mission Bay | San Francisco | California |
United States | UCSF Medical Center-Parnassus | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Overlook Hospital | Summit | New Jersey |
United States | Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida |
United States | Mercy Children's Hospital | Toledo | Ohio |
United States | New York Medical College | Valhalla | New York |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Saint Mary's Hospital | West Palm Beach | Florida |
United States | Alfred I duPont Hospital for Children | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event-free Survival | Estimated 4-year EFS where EFS is calculated as the time from study enrollment to disease progression, disease relapse, occurrence of a second malignant neoplasm, death from any cause or last follow-up whichever occurs first. Kaplan-Meier method is used for estimation. Patients without an event are censored at last contact. | Up to 4 years after study enrollment | |
Primary | Overall Survival (OS) | Estimated 4-year survival, where survival is calculated as the time from study enrollment to death from any cause or last follow-up alive whichever occurs first. Kaplan-Meier method is used for estimation. Patients alive at last contact are censored. | Up to 4 years after study enrollment | |
Primary | Toxic Death | The number of patients who experience death that is considered to be primarily attributable to complications of treatment. | During and after completion of study treatment up to 1 year after enrollment. | |
Secondary | Non-hematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy | Number of Participants with Nonhematological Toxicity Associated With Chemotherapy: Grade 3 or Higher During Protocol Therapy. | During protocol therapy up to 1 year after enrollment. |
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---|---|---|---|
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