Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Dactinomycin; Etoposide; Etoposide phosphate; Ifosfamide; Isophosphamide mustard; Lenograstim; Mesna; Sargramostim; Vincristine

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