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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00072280




Registration number
NCT00072280
Ethics application status
Date submitted
4/11/2003
Date registered
6/11/2003
Date last updated
30/09/2014

Titles & IDs
Public title
Surgery and/or Chemotherapy in Treating Children With Infantile, Congenital, or Childhood Fibrosarcoma
Scientific title
A Pilot Phase II Study for Children With Infantile Fibrosarcoma
Secondary ID [1] 0 0
CDR0000339565
Secondary ID [2] 0 0
ARST03P1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - dactinomycin
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - etoposide
Treatment: Drugs - ifosfamide
Treatment: Drugs - vincristine sulfate
Treatment: Surgery - Conventional Surgery
Other interventions - MESNA (mercaptoethane sulfonate)
Other interventions - Filgrastim

Experimental: Chemotherapy plus possible surgery - Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.
(See Interventions section for drug dosage and administration details.)

Experimental: Surgery only - Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.


Other interventions: 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

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

Treatment: Drugs: 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.

Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Surgery: 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.

Other interventions: MESNA (mercaptoethane sulfonate)
Given orally. Oral daily MESNA dose is equal to at least 60% of the daily cyclophosphamide dose.

Other interventions: 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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failure-free Survival (FFS) in "Chemotherapy Plus Possible Surgery" Arm - Failure is defined as the occurrence of one of the following: disease progression, defined as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions; relapse (defined with same criteria as for disease progression) after response; or death as a first event. Data will be summarized as number of eligible patients in each of the following categories at the time of data cutoff for analyses of 5-year FFS: 1)Failed; 2)Failure-free through 5 years of follow-up; 3)Failure-free until data cutoff (if less than 5 years of follow-up); 4)Withdrew from study; 5)Lost to follow-up. NOTE: Reported data are through March 2008 (see Caveats section).
Timepoint [1] 0 0
Study enrollment until failure, completion of follow-up, or completion of 5-year FFS analyses (up to 5 years)

Eligibility
Key inclusion 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
Minimum age
No limit
Maximum age
2 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Connecticut
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District of Columbia
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Florida
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Georgia
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Indiana
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Kentucky
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Louisiana
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Maine
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan
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New Zealand
State/province [36] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 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.
Trial website
https://clinicaltrials.gov/show/NCT00072280
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mignon Loh, MD
Address 0 0
University of California, San Francisco
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00072280