Status:
TERMINATED
Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
OBJECTIVES: Primary * Determine the event-free and relapse-free survival of children with initially unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant chemotherap...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00072280
Start Date
November 1 2004
End Date
March 1 2008
Last Update
September 30 2014
Active Locations (74)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
2
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
4
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354