Topotecan, G-CSF, and Radiation Therapy in Treating Young Patients With Newly Diagnosed Brain Stem Glioma
Brain Tumors, Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring untreated childhood brain stem glioma
Eligibility Criteria
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
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Children's Hospital Central California
- Children's Hospital of Orange County
- Sutter Cancer Center
- Stanford Comprehensive Cancer Center - Stanford
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Nemours Children's Clinic
- University of Miami Sylvester Comprehensive Cancer Center
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- Nemours Children's Clinic - Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Cancer Research Center of Hawaii
- St. Luke's Mountain States Tumor Institute - Boise
- University of Illinois Cancer Center
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Advocate Christ Medical Center
- Saint Jude Midwest Affiliate
- Indiana University Cancer Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Kosair Children's Hospital
- CancerCare of Maine at Eastern Maine Medial Center
- Floating Hospital for Children at Tufts - New England Medical Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- C.S. Mott Children's Hospital at University of Michigan Medical Center
- Barbara Ann Karmanos Cancer Institute
- Spectrum Health Hospital - Butterworth Campus
- CCOP - Kalamazoo
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota Medical Center & Children's Hospital - Fairview
- Mayo Clinic Cancer Center
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- University of New Mexico Cancer Research and Treatment Center
- NYU Cancer Institute at New York University Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Blumenthal Cancer Center at Carolinas Medical Center
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Oklahoma University Cancer Institute
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Driscoll Children's Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Methodist Children's Hospital of South Texas
- Primary Children's Medical Center
- Providence Cancer Center at Sacred Heart Medical Center
- West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- Midwest Children's Cancer Center
- Royal Children's Hospital
- Women's and Children's Hospital
- Princess Margaret Hospital for Children
- Children's Hospital of Western Ontario
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Saskatoon Cancer Centre at the University of Saskatchewan
- Swiss Pediatric Oncology Group Bern
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Dose Level I (0.5 mg/m^2)
Dose Level 2 (0.6 mg/m^2)
Radiation Therapy + Topotecan hydrochloride daily before each dose of irradiation (radiation therapy) + filgrastim (G-CSF) (p.r.n)
Radiation Therapy + Topotecan hydrochloride daily before each dose of irradiation (radiation therapy) + filgrastim (G-CSF) (p.r.n.)