Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Sarcoma
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring childhood fibrosarcoma, nonmetastatic childhood soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed infantile, congenital, or pediatric fibrosarcoma Initial biopsy or surgery performed within the past 35 days No evidence of distant metastases Available tissue for central review PATIENT CHARACTERISTICS: Age Under 2 at diagnosis Performance status Zubrod Score (ECOG) Life expectancy At least 8 weeks Hematopoietic Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3* Hemoglobin at least 10.0 g/dL* NOTE: *Transfusions allowed Hepatic Total bilirubin no greater than 1.5 times upper limit of normal (ULN) (patients over 4 weeks of age) Patients under 4 weeks of age with an indirect hyperbilirubinemia are eligible, provided the following criteria are met: At least 2 bilirubin values at separate timepoints show a decrease in measurement Direct bilirubin is no greater than 20% of the total bilirubin Direct bilirubin no greater than 1.5 times ULN Alanine Aminotransferase (ALT) less than 2.5 times ULN Renal Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min PRIOR/CONCURRENT THERAPY: Biologic therapy No concurrent sargramostim (GM-CSF) Chemotherapy No prior chemotherapy No other concurrent anticancer chemotherapy Endocrine therapy Not specified Radiotherapy No prior or concurrent radiotherapy except emergent radiotherapy for impending tracheal compression Surgery See Disease Characteristics
Sites / Locations
- Phoenix Children's Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Kaiser Permanente Medical Center - Oakland
- UCSF Comprehensive Cancer Center
- Stanford Comprehensive Cancer Center - Stanford
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Lee Cancer Care of Lee Memorial Health System
- University of Miami Sylvester Comprehensive Cancer Center
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Winship Cancer Institute of Emory University
- MBCCOP - Medical College of Georgia Cancer Center
- Indiana University Cancer Center
- St. Vincent Indianapolis Hospital
- Kosair Children's Hospital
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- CancerCare of Maine at Eastern Maine Medial Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- Hurley Medical Center
- Spectrum Health Hospital - Butterworth Campus
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Children's Hospitals and Clinics of Minneapolis
- University of Minnesota Medical Center & Children's Hospital - Fairview
- University of Mississippi Medical Center
- Children's Mercy Hospital
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- Herbert Irving Comprehensive Cancer Center at Columbia University
- SUNY Upstate Medical University Hospital
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Duke Comprehensive Cancer Center
- Children's Hospital Medical Center of Akron
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Columbus Children's Hospital
- Children's Medical Center - Dayton
- Tod Children's Hospital - Forum Health
- OU Cancer Institute
- Geisinger Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- Rhode Island Hospital Comprehensive Cancer Center
- Hollings Cancer Center at Medical University of South Carolina
- Greenville Hospital System Cancer Center
- East Tennessee Children's Hospital
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Baylor University Medical Center - Houston
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- Primary Children's Medical Center
- Providence Cancer Center at Sacred Heart Medical Center
- St. Vincent Hospital Regional Cancer Center
- Marshfield Clinic - Marshfield Center
- Midwest Children's Cancer Center
- Westmead Institute for Cancer Research at Westmead Hospital
- Women's and Children's Hospital
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- IWK Health Centre
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Saskatoon Cancer Centre at the University of Saskatchewan
- Starship Children's Health
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Chemotherapy plus possible surgery
Surgery only
Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery. (See Interventions section for drug dosage and administration details.)
Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.