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Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Not Recruiting
Trial ID: NCT00072280
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Giving combination chemotherapy before surgery may
shrink the tumor so that it can be removed. Giving combination chemotherapy after surgery may
kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well surgery and/or combination chemotherapy
work in treating children with fibrosarcoma.
Official Title
A Pilot Phase II Study for Children With Infantile Fibrosarcoma
Stanford Investigator(s)
Eligibility
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
Intervention(s):
biological: dactinomycin
drug: vincristine sulfate
drug: cyclophosphamide
drug: etoposide
drug: ifosfamide
procedure: conventional surgery
biological: MESNA (mercaptoethane sulfonate)
biological: Filgrastim
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Min Wang
6507364281