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

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.

Conditions

• Sarcoma

Interventions

BIOLOGICAL

dactinomycin

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

DRUG

cyclophosphamide

Given IV over 60 minutes, dose 25 mg/kg on days 1,22,43 and 64.

DRUG

etoposide

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.

DRUG

ifosfamide

Given IV over 1 hour, dose 60mg/kg in D5 1/4 NS 10 cc/kg IV on days 1-5 of IE Cycle

DRUG

vincristine sulfate

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

PROCEDURE

Conventional Surgery

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.

BIOLOGICAL

MESNA (mercaptoethane sulfonate)

Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.

BIOLOGICAL

Filgrastim

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Mignon Loh, MD · University of California, San Francisco

• Anne B. Warwick, MD, MPH · Medical College of Wisconsin

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-11-30

Primary Completion

2008-03-31

Completion

2008-03-31

Countries

• United States
• Australia
• Canada
• New Zealand

Study Locations