Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
Sarcoma

About this trial
This is an interventional treatment trial for Sarcoma focused on measuring recurrent childhood rhabdomyosarcoma, recurrent osteosarcoma, embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, recurrent childhood soft tissue sarcoma, extraosseous Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is relapsed or refractory to conventional therapy at original diagnosis including: Brain tumors Gliomas or astrocytomas Medulloblastomas or primitive neuroectodermal tumor (PNET) in CNS (Brain tumor stratum closed to accrual effective 07/02/2001) Sarcomas Soft tissue sarcoma (undifferentiated sarcoma, embryonal or alveolar rhabdomyosarcoma (RMS), or non-RMS soft tissue sarcoma) Osteosarcoma Ewing's sarcoma/peripheral PNET tumors Neuroblastoma (Neuroblastoma stratum closed to accrual effective 07/02/2001) Histology requirement waived for brain stem tumors (Brain tumor stratum closed to accrual effective 07/02/2001) Measurable disease documented by clinical, radiographic, or histologic criteria Lesions in previously irradiated fields may be used to assess tumor response if there has been evidence of subsequent tumor growth in those fields No bone marrow metastases with granulocytopenia and/or thrombocytopenia PATIENT CHARACTERISTICS: Age: 30 days to 21 years at diagnosis Performance status: ECOG 0-2 Life expectancy: More than 2 months Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 10.0 g/dL (may receive RBC transfusions) Platelet count at least 100,000/mm3 (50,000/mm3 if post bone marrow transplantation) (transfusion independent) Hepatic: Bilirubin no greater than 1.5 times normal SGOT or SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: No greater than grade 2 CNS toxicity OR Stable CNS status for brain tumors (Brain tumor stratum closed to accrual effective 07/02/2001) Seizure disorders allowed if well-controlled with anticonvulsants Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior bone marrow transplantation and recovered At least 2 weeks since prior cytokines and recovered No concurrent filgrastim (G-CSF) or other cytokines No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered No prior topotecan or other camptothecins No other concurrent anticancer chemotherapy Endocrine therapy: Concurrent corticosteroids for CNS tumors with increased intracranial pressure allowed (Brain tumor stratum closed to accrual effective 07/02/2001) Radiotherapy: At least 2 months since prior craniospinal radiotherapy or radiotherapy to more than 50% of the bone marrow and recovered Concurrent radiotherapy to localized painful lesions allowed provided that at least 1 measurable lesion is not irradiated Other: Recovered from any other prior therapy
Sites / Locations
- University of Alabama at Birmingham Comprehensive Cancer Center
- University of South Alabama Medical Center
- Phoenix Children's Hospital
- Arizona Cancer Center
- University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- City of Hope Comprehensive Cancer Center
- Rebecca and John Moores UCSD Cancer Center
- Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center
- Children's Hospital Los Angeles
- Cedars-Sinai Medical Center
- Jonsson Comprehensive Cancer Center, UCLA
- Children's Hospital Central California
- Children's Hospital of Oakland
- Chao Family Comprehensive Cancer Center
- Children's Hospital of Orange County
- Lucile Packard Children's Hospital at Stanford
- Sutter Cancer Center
- University of California Davis Medical Center
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
- Children's Hospital San Diego
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- UCSF Comprehensive Cancer Center
- Santa Barbara Cottage Hospital
- Kaiser Permanente Medical Center - Santa Clara
- David Grant Medical Center
- Children's Hospital of Denver
- Childhood Hematology/Oncology Associates
- Presbyterian-St Luke's Medical Center
- University of Connecticut Health Center
- Yale Comprehensive Cancer Center
- Alfred I. Dupont Institute
- Lombardi Cancer Center
- Children's National Medical Center
- Walter Reed Army Medical Center
- Broward General Medical Center
- Children's Hospital of Southwest Florida
- Shands Hospital and Clinics, University of Florida
- Joe DiMaggio Children's Hospital at Memorial
- Nemours Children's Clinic
- University of Miami-Jackson Memorial Hospital
- Miami Children's Hospital
- Baptist Hospital of Miami
- Florida Hospital Cancer Institute
- Nemours Children's Clinic-Orlando
- Sacred Heart Children's Hospital
- All Children's Hospital
- Tampa Children's Hospital
- St. Mary's Hospital
- Emory University Hospital - Atlanta
- Children's Healthcare of Atlanta - Scottish Rite
- Medical College of Georgia Comprehensive Cancer Center
- Medical Center of Central Georgia
- Memorial Health University Medical Center, Inc.
- Cancer Research Center of Hawaii
- MBCCOP - Hawaii
- Tripler Army Medical Center
- Mountain States Tumor Institute
- University of Chicago Cancer Research Center
- Rush-Presbyterian-St. Luke's Medical Center
- University of Illinois at Chicago
- Children's Memorial Hospital - Chicago
- Hope Children's Hospital
- Lutheran General Hospital
- Saint Jude Midwest Affiliate
- Southern Illinois University School of Medicine
- Indiana University Cancer Center
- St. Vincent Hospital and Health Care Center
- Raymond Blank Memorial Hospital for Children
- John Stoddard Cancer Center
- Holden Comprehensive Cancer Center
- Wesley Medical Center
- Albert B. Chandler Medical Center, University of Kentucky
- Kosair Children's Hospital
- Tulane University School of Medicine
- Children's Hospital of New Orleans
- Ochsner Clinic
- Eastern Maine Medical Center
- Maine Children's Cancer Program
- Marlene and Stewart Greenebaum Cancer Center, University of Maryland
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children
- Dana-Farber Cancer Institute
- Baystate Medical Center
- University of Massachusetts Memorial Medical Center - University Campus
- Mott Children's Hospital
- Children's Hospital of Michigan
- Henry Ford Hospital
- St. John Hospital and Medical Center
- Michigan State University
- Hurley Medical Center
- Spectrum Health and DeVos Children's Hospital
- Bronson Methodist Hospital
- CCOP - Beaumont
- William Beaumont Hospital
- St. Mary's/Duluth Clinic Cancer Center
- Children's Hospitals and Clinics - Minneapolis
- Mayo Clinic Cancer Center
- Children's Hospitals and Clinics of Minnesota
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Cardinal Glennon Children's Hospital
- St. Louis Children's Hospital
- Children's Hospital of Omaha
- University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center
- Hackensack University Medical Center
- Cancer Institute of New Jersey
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- Atlantic Health System
- University of New Mexico Cancer Research and Treatment Center
- Cancer Center of Albany Medical Center
- Albert Einstein Clinical Cancer Center
- Brooklyn Hospital Center
- State University of New York Health Science Center at Brooklyn College of Medicine
- Brookdale University Hospital and Medical Center
- Maimonides Medical Center
- Roswell Park Cancer Institute
- North Shore University Hospital
- Schneider Children's Hospital
- New York Presbyterian Hospital - Cornell Campus
- Memorial Sloan-Kettering Cancer Center
- Mount Sinai School of Medicine
- Columbia Presbyterian Hospital
- James P. Wilmot Cancer Center
- State University of New York Health Sciences Center - Stony Brook
- State University of New York - Upstate Medical University
- New York Medical College
- Mission Saint Joseph's Health System
- Lineberger Comprehensive Cancer Center, UNC
- Carolinas Medical Center
- Presbyterian Healthcare
- Duke Comprehensive Cancer Center
- East Carolina University School of Medicine
- Comprehensive Cancer Center at Wake Forest University
- Dakota Cancer Institute
- Children's Hospital Medical Center of Akron
- Children's Hospital Medical Center - Cincinnati
- Ireland Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Children's Hospital of Columbus
- Children's Medical Center - Dayton
- Toledo Children's Hospital
- St. Vincent Mercy Medical Center
- Forum Health-Tod Childrens Hospital
- Children's Hospital of Oklahoma
- CCOP - Oklahoma
- Natalie Warren Bryant Cancer Center
- Doernbecher Children's Hospital
- Legacy Emanuel Hospital and Health Center
- Geisinger Medical Center
- Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- St. Christopher's Hospital for Children
- Children's Hospital of Pittsburgh
- Rhode Island Hospital
- Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Children's Hospital of Greenville Hospital System
- Avera Cancer Institute
- Sioux Valley Hospital
- East Tennessee State University Cancer Center at JCMC
- East Tennessee Children's Hospital
- Saint Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine
- Children's Hospital of Austin
- Medical City Dallas Hospital
- Simmons Cancer Center - Dallas
- Cook Children's Medical Center - Fort Worth
- University of Texas Medical Branch
- University of Texas - MD Anderson Cancer Center
- Baylor College of Medicine
- San Antonio Military Pediatric Cancer and Blood Disorders Center
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Health Care System
- Scott and White Memorial Hospital
- Huntsman Cancer Institute
- Vermont Cancer Center
- Cancer Center at the University of Virginia
- Inova Fairfax Hospital
- Children's Hospital of the King's Daughters
- Naval Medical Center, Portsmouth
- Massey Cancer Center
- Carilion Medical Center for Children
- Children's Hospital and Regional Medical Center - Seattle
- Fred Hutchinson Cancer Research Center
- Group Health Cooperative
- Deaconess Medical Center
- Mary Bridge Children's Health Center
- Madigan Army Medical Center
- West Virginia University - Charleston
- Cabell-Huntington Hospital, Inc
- West Virginia University Hospitals
- Bellin Memorial Hospital
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
- St. Vincent Hospital
- Gundersen Lutheran Medical Center
- University of Wisconsin Hospital and Clinics
- Marshfield Clinic
- Midwest Children's Cancer Center
- Sydney Children's Hospital
- Children's Hospital at Westmead
- Royal Children's Hospital
- Women's and Children's Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- Cross Cancer Institute
- British Columbia Children's Hospital
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- Children's Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- McGill University Health Center - Montreal Children's Hospital
- Hopital Sainte Justine
- Centre Hospitalier de L'Universite Laval
- Laval University Medical Center
- Allan Blair Cancer Centre
- Saskatoon Cancer Centre
- Academisch Ziekenhuis Groningen
- Starship Children's Hospital
- University of Puerto Rico School of Medicine Medical Sciences Campus
- San Jorge Childrens Hospital
- Swiss Pediatric Oncology Group Bern
- Swiss Pediatric Oncology Group Geneva
- Swiss Pediatric Oncology Group Lausanne
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive topotecan IV continuously on days 1-21. Treatment continues at least every 4 weeks in the absence of unacceptable toxicity or disease progression.