Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Fibrosarcoma
Intervention: dactinomycin; cyclophosphamide; etoposide; ifosfamide; vincristine sulfate; Conventional Surgery; MESNA (mercaptoethane sulfonate); Filgrastim
Intervention description: Given Slow intravenous (IV) push over 1-5 minutes, dose < 1yr 0.025 mg/kg > or = 1 yr 0.045 mg/kg (max dose 2.5 mg) on days 1,22,43 and 64; Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.; Given IV over 1 hour, dose 3.3 mg/kg in normal saline (NS) 10 cc/kg (or to equal 0.4 mg/mL concentration) on days 1-5 of IE cycle.; Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle; Given IV Push over 1 minute, dose 0.05 mg/kg (max dose 2 mg) on days 1,8,15,22,29,36,43,50,57 and 64; Applied only when lesion is resectable. Surgery is the primary means of local control in this study and reasonable attempts at achieving clear margins with an "envelope" of normal tissue should be undertaken at the initial and/or subsequent resections.; Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.; Given IV - Only use filgrastim if chemotherapy has been delayed or modified for hematologic toxicity, or if patient experiences a significant life-threatening toxicity due to bone marrow suppression
Intervention MeSH terms: Dactinomycin; Cyclophosphamide; Ifosfamide; Isophosphamide mustard; Etoposide; Vincristine; Lenograstim; Mesna
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Maximum age: 2 Years
Healthy volunteers: No
Keywords: childhood fibrosarcoma; nonmetastatic childhood soft tissue sarcoma

Summary:

      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.
    

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