Brain Tumors Clinical Trial
Official title:
A Phase I/II Study of Topotecan With G-CSF and Radiation Therapy in Children With Malignant Intrinsic Pontine Brainstem Gliomas of Childhood
Verified date | December 2013 |
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, such as topotecan, work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing.
Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in
bone marrow or peripheral blood and may help the immune system recover from the side effects
of chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Topotecan
may make tumor cells more sensitive to radiation therapy . Giving topotecan and G-CSF
together with radiation therapy may be an effective treatment for brain stem glioma.
PURPOSE: This phase I/II trial is studying the side effects and best dose of topotecan when
given together with G-CSF and radiation therapy and to see how well they work in treating
young patients with newly diagnosed brain stem glioma.
Status | Terminated |
Enrollment | 7 |
Est. completion date | |
Est. primary completion date | October 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Years to 21 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of intrinsic pontine brain stem glioma within the past 30 days - Histologic confirmation not required provided the tumor has a pontine epicenter AND exhibits diffuse (rather than focal) involvement of = 2/3 of the pons with or without extension to the adjacent medulla or midbrain* NOTE: *Brain stem tumors that do not meet these criteria must be histologically confirmed as grade III or IV malignant glioma - Measurable disease by radiographic imaging - Post-operative MRI required within the past 30 days if patient had a biopsy or surgical resection - No disseminated disease - No neurofibromatosis type 1 PATIENT CHARACTERISTICS: Age - 3 to 21 at diagnosis Performance status - Lansky 50-100% OR - Karnofsky 50-100% Life expectancy - At least 8 weeks Hematopoietic - Absolute neutrophil count = 1,000/mm^3 - Platelet count = 100,000/mm^3 (transfusion independent) - Hemoglobin = 10.0 g/dL (transfusion allowed) Hepatic - Bilirubin = 1.5 times upper limit of normal (ULN) - ALT < 2.5 times ULN Renal - Creatinine clearance or radioisotope glomerular filtration rate = 70 mL/min OR - Creatinine based on age as follows: - No greater than 0.8 mg/dL (for patients = 5 years of age) - No greater than 1.0 mg/dL (for patients 6 to 10 years of age) - No greater than 1.2 mg/dL (for patients 11 to 15 years of age) - No greater than 1.5 mg/dL (for patients over 15 years of age) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Not severely somnolent or comatose - Central cortical neurotoxicity scale < grade 3 PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunomodulating agents Chemotherapy - No other concurrent anticancer chemotherapy Endocrine therapy - Concurrent corticosteroids allowed for neurological deficits related to the tumor Radiotherapy - No prior radiotherapy Surgery - See Disease Characteristics - Prior biopsy or surgical resection for malignant brain stem glioma allowed Other - No other prior therapy for malignant brain stem glioma |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Royal Children's Hospital | Herston, Brisbane | Queensland |
Australia | Women's and Children's Hospital | North Adelaide | South Australia |
Australia | Princess Margaret Hospital for Children | Perth | Western Australia |
Canada | Children's Hospital of Western Ontario | London | Ontario |
Canada | Hopital Sainte Justine | Montreal | Quebec |
Canada | Montreal Children's Hospital at McGill University Health Center | Montreal | Quebec |
Canada | Saskatoon Cancer Centre at the University of Saskatchewan | Saskatoon | Saskatchewan |
Switzerland | Swiss Pediatric Oncology Group Bern | Bern | |
United States | University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico |
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 | CancerCare of Maine at Eastern Maine Medial Center | Bangor | Maine |
United States | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham | Alabama |
United States | St. Luke's Mountain States Tumor Institute - Boise | Boise | Idaho |
United States | Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Floating Hospital for Children at Tufts - New England Medical Center | Boston | Massachusetts |
United States | Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina |
United States | West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston | West Virginia |
United States | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
United States | University of Illinois Cancer 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 | Palmetto Health South Carolina Cancer Center | Columbia | South Carolina |
United States | Columbus Children's Hospital | Columbus | Ohio |
United States | Driscoll Children's Hospital | Corpus Christi | Texas |
United States | Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas | Texas |
United States | Children's Medical Center - Dayton | Dayton | Ohio |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Southern California Permanente Medical Group | Downey | California |
United States | Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington | Connecticut |
United States | Lee Cancer Care of Lee Memorial Health System | Fort Myers | Florida |
United States | Cook Children's Medical Center - Fort Worth | Fort Worth | Texas |
United States | University of Florida Shands Cancer Center | Gainesville | Florida |
United States | Spectrum Health Hospital - Butterworth Campus | Grand Rapids | Michigan |
United States | Hackensack University Medical Center Cancer Center | Hackensack | New Jersey |
United States | Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Cancer Research Center of Hawaii | Honolulu | Hawaii |
United States | Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington | West Virginia |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Nemours Children's Clinic | Jacksonville | Florida |
United States | CCOP - Kalamazoo | Kalamazoo | Michigan |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas |
United States | Sunrise Hospital and Medical Center | Las Vegas | Nevada |
United States | Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Kosair Children's Hospital | Louisville | Kentucky |
United States | Children's Hospital Central California | Madera | California |
United States | University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota |
United States | University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis | Minnesota |
United States | Overlook Hospital | Morristown | New Jersey |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York |
United States | NYU Cancer Institute at New York University Medical Center | New York | New York |
United States | Advocate Christ Medical Center | Oak Lawn | Illinois |
United States | Oklahoma University Cancer Institute | Oklahoma City | Oklahoma |
United States | Children's Hospital of Orange County | Orange | California |
United States | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida |
United States | Nemours Children's Clinic - Orlando | Orlando | Florida |
United States | Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola | Florida |
United States | Saint Jude Midwest Affiliate | Peoria | Illinois |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Sutter Cancer Center | 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 | Providence Cancer Center at Sacred Heart Medical Center | Spokane | Washington |
United States | Siteman Cancer Center at Barnes-Jewish Hospital | St. Louis | Missouri |
United States | Stanford Comprehensive Cancer Center - Stanford | Stanford | California |
United States | SUNY Upstate Medical University Hospital | Syracuse | New York |
United States | St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa | Florida |
United States | New York Medical College | Valhalla | New York |
Lead Sponsor | Collaborator |
---|---|
Children's Oncology Group | National Cancer Institute (NCI) |
United States, Australia, Canada, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to treatment failure (e.g., tumor progression, tumor recurrence, or death from any cause) | From date of enrollment until the first occurrence of relapse, progressive disease, secondary malignancy, or death or until last contact if none of these events occur, assessed up to 3 years | No | |
Secondary | Time to death | From the time of study entry to the first occurrence of death by any cause | Yes |
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