Brain Tumors Clinical Trial
Official title:
A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma
Verified date | July 2014 |
Source | Children's Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor
cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of etoposide plus radiation therapy
followed by combination chemotherapy in treating children with newly diagnosed advanced
medulloblastoma.
Status | Completed |
Enrollment | 53 |
Est. completion date | March 2008 |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 21 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically diagnosed advanced (high grade) childhood medulloblastoma - Residual disease of at least 1.5 cm2 in size on MRI or CT scan OR - Evidence of CNS or extraneural metastases PATIENT CHARACTERISTICS: Age: - 3 to 21 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - SGPT less than 5 times normal - Bilirubin less than 1.5 mg/dL Renal: - Creatinine less than 1.7 mg/dL OR - Creatinine clearance greater than 70 mL/min Other: - Not pregnant or nursing - 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: - Not specified |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Children's Hospital | Calgary | Alberta |
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Children's Hospital | Hamilton | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | McGill University Health Center - Montreal Children's Hospital | Montreal | Quebec |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Canada | Centre Hospitalier de L'Universite Laval | Sainte Foy | Quebec |
Canada | Hospital for Sick Children | Toronto | Ontario |
Netherlands | Academisch Ziekenhuis Groningen | Groningen | |
Puerto Rico | San Jorge Childrens Hospital | Santurce | |
Switzerland | Swiss Pediatric Oncology Group Bern | Bern | |
Switzerland | Clinique de Pediatrie | Geneva | |
United States | University of New Mexico School of Medicine | Albuquerque | New Mexico |
United States | Mission Saint Joseph's Health System | Asheville | North Carolina |
United States | Emory University Hospital - Atlanta | Atlanta | Georgia |
United States | Johns Hopkins Oncology Center | Baltimore | Maryland |
United States | Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland |
United States | Eastern Maine Medical Center | Bangor | Maine |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Boston Floating Hospital Infants and Children | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital Cancer Center | Boston | Massachusetts |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Vermont Cancer Center | Burlington | Vermont |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University Medical School-Charleston | Charleston | West Virginia |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Presbyterian Healthcare | Charlotte | North Carolina |
United States | Children's Memorial Hospital, Chicago | Chicago | Illinois |
United States | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois |
United States | University of Missouri-Columbia Hospital and Clinics | Columbia | Missouri |
United States | Medical City Dallas Hospital | Dallas | Texas |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | Children's Hospital of Michigan | Detroit | Michigan |
United States | St. John's Hospital and Medical Center | Detroit | Michigan |
United States | Duke Comprehensive Cancer Center | Durham | North Carolina |
United States | Inova Fairfax Hospital | Falls Church | Virginia |
United States | Hurley Medical Center | Flint | Michigan |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | Shands Hospital and Clinics, University of Florida | Gainesville | Florida |
United States | University of Texas Medical Branch | Galveston | Texas |
United States | St. Vincent Hospital | Green Bay | Wisconsin |
United States | Children's Hospital of Greenville Hospital System | Greenville | South Carolina |
United States | East Carolina University School of Medicine | Greenville | North Carolina |
United States | CCOP - Northern New Jersey | Hackensack | New Jersey |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Tripler Army Medical Center | Honolulu | Hawaii |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | James H. Quillen College of Medicine | Johnson City | Tennessee |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi |
United States | University of California San Diego Cancer Center | La Jolla | California |
United States | San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base | Texas |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Miami Children's Hospital | Miami | Florida |
United States | Sylvester Cancer Center, University of Miami | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | MBCCOP - Gulf Coast | Mobile | Alabama |
United States | West Virginia University Hospitals | Morgantown | West Virginia |
United States | Yale Comprehensive Cancer Center | New Haven | Connecticut |
United States | Schneider Children's Hospital | New Hyde Park | New York |
United States | CCOP - Ochsner | New Orleans | Louisiana |
United States | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Hope Children's Hospital | Oak Lawn | Illinois |
United States | Oklahoma Memorial Hospital | Oklahoma City | Oklahoma |
United States | Walt Disney Memorial Cancer Institute | Orlando | Florida |
United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | St. Christopher's Hospital for Children | Philadelphia | Pennsylvania |
United States | CCOP - Columbia River Program | Portland | Oregon |
United States | Legacy Emanuel Hospital and Health Center | Portland | Oregon |
United States | Maine Children's Cancer Program | Portland | Maine |
United States | Naval Medical Center, Portsmouth | Portsmouth | Virginia |
United States | Massey Cancer Center | Richmond | Virginia |
United States | Carilion Roanoke Community Hospital | Roanoke | Virginia |
United States | University of Rochester Cancer Center | Rochester | New York |
United States | Sutter Cancer Center | Sacramento | California |
United States | University of California Davis Medical Center | Sacramento | California |
United States | Cardinal Glennon Children's Hospital | Saint Louis | Missouri |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | MBCCOP - South Texas Pediatric | San Antonio | Texas |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
United States | Children's Hospital and Health Center | San Diego | California |
United States | Kaiser Permanente-Southern California Permanente Medical Group | San Diego | California |
United States | Naval Medical Center - San Diego | San Diego | California |
United States | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California |
United States | State University of New York Health Sciences Center - Stony Brook | Stony Brook | New York |
United States | State University of New York - Upstate Medical University | Syracuse | New York |
United States | Madigan Army Medical Center | Tacoma | Washington |
United States | CCOP - Florida Pediatric | Tampa | Florida |
United States | Scott and White Clinic | Temple | Texas |
United States | Arizona Cancer Center | Tucson | Arizona |
United States | Natalie Warren Bryant Cancer Center | Tulsa | Oklahoma |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
United States | St. Mary's Hospital | West Palm Beach | Florida |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Regional Medical Center | Wichita | Kansas |
United States | Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina |
United States | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Canada, Netherlands, Puerto Rico, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the efficacy of oral etoposide at 50 mg/m2/day given concurrently with radiotherapy followed with dose intensive adjuvant chemotherapy in children with newly diagnosed high stage medulloblastoma | It is possible that unacceptably high levels of toxicity may arise. For this reason, there is a 3-stage stopping rule designed to allow the Study Coordinator to stop this study early if it appears that the true proportion of eligible patients who suffer unacceptable levels of toxicity exceeds 10%. | End of course 1 (week 10) | Yes |
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