Sarcoma Clinical Trial
Official title:
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
Verified date | March 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. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating infants with malignant brain or spinal cord
tumors.
Status | Completed |
Enrollment | 94 |
Est. completion date | October 2011 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 2 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically proven malignant brain or spinal cord tumor, including the following: - Primitive neuroectodermal tumor - Ganglioneuroblastoma - Medulloblastoma neuroblastoma - Desmoplastic medulloblastoma - Medulloepithelioma - Ependymoma neuroepithelioma - Anaplastic ependymoma germ cell tumor - Astrocytoma germinoma - Anaplastic astrocytoma - Embryonal carcinoma - Glioblastoma endodermal sinus tumor - Gliosarcoma malignant teratoma - Choroid plexus carcinoma - Mixed germ cell tumor - Cerebellar sarcoma - Pineoblastoma - Atypical teratoid/rhabdoid tumor - Choriocarcinoma - Teratoma (malignant or with malignant transformations) - Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI PATIENT CHARACTERISTICS: Age: - 6 months to less than 3 years Performance Status: - Not specified Life Expectancy: - More than 8 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL Renal: - Glomerular filtration rate or creatinine clearance greater than 70 mL/min PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic therapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior corticosteroids allowed Radiotherapy: - No prior radiotherapy Surgery: - No more than 6 weeks since prior surgery - Recovered from prior surgery (stable) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Canada | Allan Blair Cancer Centre at Pasqua Hospital | Regina | Saskatchewan |
Canada | Hospital for Sick Children | Toronto | Ontario |
Canada | Children's & Women's Hospital of British Columbia | Vancouver | British Columbia |
Canada | CancerCare Manitoba | Winnipeg | Manitoba |
United States | Akron Children's Hospital | Akron | Ohio |
United States | Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo | Texas |
United States | C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor | Michigan |
United States | AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Atlanta | Georgia |
United States | MBCCOP - Medical College of Georgia Cancer Center | Augusta | Georgia |
United States | Children's Hospital Center for Cancer and Blood Disorders | Aurora | Colorado |
United States | Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx | New York |
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Dayton Children's - Dayton | Dayton | Ohio |
United States | Presbyterian - St. Luke's Medical Center | Denver | Colorado |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | CCOP - MeritCare Hospital | Fargo | North Dakota |
United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan |
United States | Penn State Children's Hospital | Hershey | Pennsylvania |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | CCOP - Nevada Cancer Research Foundation | Las Vegas | Nevada |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | Childrens Hospital Los Angeles | Los Angeles | California |
United States | Jonsson Comprehensive Cancer Center at UCLA | Los Angeles | California |
United States | Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles | California |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Covenant Children's Hospital | Lubbock | Texas |
United States | Children's Hospital Central California | Madera | California |
United States | Winthrop University Hospital | Mineola | New York |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
United States | Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown | New Jersey |
United States | Overlook Hospital | Morristown | New Jersey |
United States | Beth Israel Medical Center - Petrie Division | New York | New York |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York | New York |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | NYU Cancer Institute at New York University Medical Center | New York | New York |
United States | Children's Hospital of The King's Daughters | Norfolk | Virginia |
United States | Children's Hospital and Research Center Oakland | Oakland | California |
United States | Children's Hospital of Orange County | Orange | California |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Knight Cancer Institute at Oregon Health and Science University | Portland | Oregon |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Kaiser Permanente Medical Center - Oakland | Sacramento | California |
United States | Primary Children's Medical Center | Salt Lake City | Utah |
United States | Methodist Children's Hospital of South Texas | San Antonio | Texas |
United States | UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California |
United States | Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah | Georgia |
United States | Children's Hospital and Regional Medical Center - Seattle | Seattle | Washington |
United States | Group Health Central Hospital | Seattle | Washington |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota |
United States | Deaconess Medical Center | Spokane | Washington |
United States | Children's Hospitals and Clinics of Minnesota - St. Paul | St. Paul | Minnesota |
United States | Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma | Washington |
United States | Medical University of Ohio Cancer Center | Toledo | Ohio |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington | District of Columbia |
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 | Feasibility | Demonstrate the feasibility of administering this regimen, to select an acceptable Thiotepa dose for Consolidation therapy, and to document significant toxicities and estimate their overall rates | Up to 4 weeks after completion of study treatment | Yes |
Primary | Maximal tolerated dose of thiotepa for consolidation therapy | The dose level will be assigned within 3 working days prior to beginning Consolidation. | 9 weeks | Yes |
Primary | Overall rates of significant toxicities including grade IV ototoxicity, electrolytic wasting (grade IV), and hemorrhagic cystitis (grade IV) | Estimates will be obtained using life-table methods with an event defined as the first occurrence of toxicity. Graded using the CCG Toxicity and Complications Criteria. | Up to 6 years | Yes |
Secondary | Event Free Survival | From the time of study entry to the first occurrence of death by any cause, progression or recurrence of disease or occurrence of a second malignant neoplasm, assessed up | No |
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