Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Brain Tumors, Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain Tumors focused on measuring recurrent childhood brain stem glioma, recurrent childhood visual pathway glioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, childhood low-grade cerebellar astrocytoma, childhood low-grade cerebral astrocytoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed low grade residual astrocytomas or other eligible residual tumors of the brain interpreted as low grade (WHO grades I and II) such as the following: Glial Tumors Astrocytic tumors Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic) Pilocytic astrocytoma Pleomorphic xanthoastrocytomas Subependymal giant cell astrocytoma Infantile desmoplastic astrocytoma Low grade oligodendroglial tumors Low grade oligodendroglioma Low grade mixed gliomas Oligo-astrocytoma Neuronal Tumors Ganglioglioma (excluding tumors with anaplastic astrocytic components) Infantile desmoplastic ganglioglioma Chiasmatic-hypothalamic tumor without histologic confirmation All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm PATIENT CHARACTERISTICS: Age: Under 10 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 (arm II) Platelet count greater than 100,000/mm^3 (arm II) Hepatic: Not specified Renal: Creatinine less than 1.5 times upper limit of normal for age OR Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for the tumor Endocrine therapy: Prior corticosteroid therapy allowed Radiotherapy: No prior radiotherapy for the tumor Surgery: See Disease characteristics Other: Prior diuretic therapy allowed
Sites / Locations
- University of South Alabama Mitchell Cancer Institute
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- City of Hope Comprehensive Cancer Center
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Childrens Hospital Los Angeles
- Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center at UCLA
- Children's Hospital Central California
- Children's Hospital and Research Center Oakland
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford University Medical Center
- Sutter Cancer Center
- University of California Davis Cancer Center
- Kaiser Permanente Medical Center - Oakland
- Rady Children's Hospital - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center
- Santa Barbara Cottage Children's Hospital
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Children's Hospital Center for Cancer and Blood Disorders
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Yale Cancer Center
- Alfred I. duPont Hospital for Children
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Children's National Medical Center
- Broward General Medical Center Cancer Center
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Nemours Children's Clinic
- Miami Children's Hospital
- Baptist-South Miami Regional Cancer Program
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- M.D. Anderson Cancer Center at Orlando
- Nemours Children's Clinic - Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
- AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus
- MBCCOP - Medical College of Georgia Cancer Center
- Medical Center of Central Georgia
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Cancer Research Center of Hawaii
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- University of Illinois Cancer Center
- Rush University Medical Center
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Keyser Family Cancer Center at Advocate Hope Children's Hospital
- Advocate Lutheran General Cancer Care Center
- Saint Jude Midwest Affiliate
- Swedish-American Regional Cancer Center
- Simmons Cooper Cancer Institute
- Indiana University Melvin and Bren Simon Cancer Center
- St. Vincent Indianapolis Hospital
- Blank Children's Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Wesley Medical Center
- Lucille P. Markey Cancer Center at University of Kentucky
- Kosair Children's Hospital
- Tulane Cancer Center Office of Clinical Research
- Children's Hospital of New Orleans
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- CancerCare of Maine at Eastern Maine Medical Center
- Maine Children's Cancer Program at Barbara Bush Children's Hospital
- Greenebaum Cancer Center at University of Maryland Medical Center
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
- C.S. Mott Children's Hospital at University of Michigan Medical Center
- Barbara Ann Karmanos Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- CCOP - Kalamazoo
- Breslin Cancer Center at Ingham Regional Medical Center
- William Beaumont Hospital - Royal Oak Campus
- CCOP - Duluth
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- Masonic Cancer Center at University of Minnesota
- Mayo Clinic Cancer Center
- Children's Hospitals and Clinics of Minnesota - St. Paul
- University of Mississippi Cancer Clinic
- Keesler Air Force Base Medical Center
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- Children's Hospital
- CCOP - Nevada Cancer Research Foundation
- Hackensack University Medical Center Cancer Center
- St. Barnabas Medical Center Cancer Center
- Overlook Hospital
- Saint Peter's University Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- University of New Mexico Cancer Center
- Albany Medical Center Hospital
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Maimonides Cancer Center at Maimonides Medical Center
- Roswell Park Cancer Institute
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Schneider Children's Hospital
- Beth Israel Medical Center - Petrie Division
- NYU Cancer Institute at New York University Medical Center
- St. Luke's - Roosevelt Hospital Center - St.Luke's Division
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- Memorial Sloan-Kettering Cancer Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Stony Brook University Cancer Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Dakota Cancer Institute at Dakota Clinic - South University
- CCOP - MeritCare Hospital
- Akron Children's Hospital
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Nationwide Children's Hospital
- Dayton Children's - Dayton
- Toledo Hospital
- Medical University of Ohio Cancer Center
- Tod Children's Hospital
- Oklahoma University Cancer Institute
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Knight Cancer Institute at Oregon Health and Science University
- Geisinger Cancer Institute at Geisinger Health
- Penn State Children's Hospital
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh of UPMC
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Avera Cancer Institute
- Sanford Cancer Center at Sanford USD Medical Center
- East Tennessee Children's Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Dell Children's Medical Center of Central Texas
- Driscoll Children's Hospital
- Cook Children's Medical Center - Fort Worth
- University of Texas Medical Branch
- M. D. Anderson Cancer Center at University of Texas
- Wilford Hall Medical Center
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- CCOP - Scott and White Hospital
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- Inova Fairfax Hospital
- Children's Hospital of The King's Daughters
- Naval Medical Center - Portsmouth
- Virginia Commonwealth University Massey Cancer Center
- Carilion Medical Center for Children at Roanoke Community Hospital
- Children's Hospital and Regional Medical Center - Seattle
- Group Health Central Hospital
- Deaconess Medical Center
- Providence Cancer Center at Sacred Heart Medical Center
- Mary Bridge Children's Hospital and Health Center - Tacoma
- Madigan Army Medical Center - Tacoma
- West Virginia University Health Sciences Center - Charleston
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- St. Vincent Hospital Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- Marshfield Clinic - Marshfield Center
- John Hunter Hospital
- Prince of Wales Private Hospital
- Children's Hospital at Westmead
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Allan Blair Cancer Centre at Pasqua Hospital
- Saskatoon Cancer Centre at the University of Saskatchewan
- Centre Hospitalier Universitaire de Quebec
- University Medical Center Groningen
- Starship Children's Health
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Regimen A (CV Chemotherapy)
Regimen B (TPCV Chemotherapy)
Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC >1,000/$L and platelet count >100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.
Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.