Spots Global Cancer Trial Database for Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
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Trial Identification
Brief Title: Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
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
Study ID: NCT00107471
Study Description
Brief Summary: 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.
Detailed Description: OBJECTIVES: Primary * Determine the feasibility of escalating the dose of topotecan when administered with filgrastim (G-CSF) and radiotherapy, in terms of increasing the topotecan dose 25-50% above the maximum tolerated dose (MTD) determined in a prior phase I study, in young patients with newly diagnosed malignant intrinsic pontine brain stem glioma. (Phase I) * Determine the dose-limiting toxic effects of topotecan in these patients. (Phase I) * Determine the 1-year event-free survival and overall survival of patients treated with this regimen (at the MTD of topotecan determined in phase I). (Phase II) * Determine the toxicity of this regimen in these patients. (Phase II) Secondary * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a multicenter, phase I, dose-escalation study of topotecan followed by a phase II study. * Phase I: Patients receive topotecan IV over 30 minutes followed by radiotherapy once daily, 5 days a week for 6-7 weeks. During chemoradiotherapy, patients also receive filgrastim (G-CSF) IV or subcutaneously daily, if needed, until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 out of 6 patients experience dose-limiting toxicity. * Phase II: Patients receive topotecan (at the MTD determined in phase I ), G-CSF, and radiotherapy as in phase I. After completion of study treatment, patients are followed within 2 weeks, every 3 months for 1.5 years, every 6 months for 1.5 years, and then annually until disease relapse. PROJECTED ACCRUAL: A total of 3-72 patients (3-12 for phase I and 60 for phase II) will be accrued for this study within approximately 3 years.
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham, Birmingham, Alabama, United States
Phoenix Children's Hospital, Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Southern California Permanente Medical Group, Downey, California, United States
Children's Hospital Central California, Madera, California, United States
Children's Hospital of Orange County, Orange, California, United States
Sutter Cancer Center, Sacramento, California, United States
Stanford Comprehensive Cancer Center - Stanford, Stanford, 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
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, 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
St. Joseph's Cancer Institute at St. Joseph's Hospital, Tampa, Florida, United States
Cancer Research Center of Hawaii, Honolulu, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise, Boise, Idaho, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Children's Memorial Hospital - Chicago, Chicago, Illinois, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Advocate Christ Medical Center, Oak Lawn, Illinois, United States
Saint Jude Midwest Affiliate, Peoria, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center, Kansas City, Kansas, United States
Kosair Children's Hospital, Louisville, Kentucky, United States
CancerCare of Maine at Eastern Maine Medial Center, Bangor, Maine, United States
Floating Hospital for Children at Tufts - New England Medical Center, Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Spectrum Health Hospital - Butterworth Campus, Grand Rapids, Michigan, United States
CCOP - Kalamazoo, Kalamazoo, Michigan, 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
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Children's Mercy Hospital, Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital, St. Louis, Missouri, 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
Hackensack University Medical Center Cancer Center, Hackensack, New Jersey, United States
Overlook Hospital, Morristown, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, United States
NYU Cancer Institute at New York University Medical Center, New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University, New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center, Rochester, New York, United States
SUNY Upstate Medical University Hospital, Syracuse, New York, United States
New York Medical College, Valhalla, New York, United States
Blumenthal Cancer Center at Carolinas Medical Center, Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Columbus Children's Hospital, Columbus, Ohio, United States
Children's Medical Center - Dayton, Dayton, Ohio, United States
Oklahoma University Cancer Institute, Oklahoma City, Oklahoma, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina, Charleston, South Carolina, United States
Palmetto Health South Carolina Cancer Center, Columbia, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo, Amarillo, Texas, 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
Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States
Methodist Children's Hospital of South Texas, San Antonio, Texas, United States
Primary Children's Medical Center, Salt Lake City, Utah, United States
Providence Cancer Center at Sacred Heart Medical Center, Spokane, Washington, United States
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division, Charleston, West Virginia, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital, Huntington, West Virginia, United States
Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States
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, Australia
Children's Hospital of Western Ontario, London, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center, Montreal, Quebec, Canada
Hopital Sainte Justine, Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Swiss Pediatric Oncology Group Bern, Bern, , Switzerland
Contact Details
Name: Patricia L. Robertson, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
Name: Richard A. Axtell, MD
Affiliation: Helen DeVos Children's Hospital at Spectrum Health
Role: STUDY_CHAIR
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