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A Pilot Phase II Study for Children With Infantile Fibrosarcoma


Phase 2
N/A
2 Years
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

A Pilot Phase II Study for Children With Infantile Fibrosarcoma


OBJECTIVES:

Primary

- Determine the event-free and relapse-free survival of children with initially
unresectable congenital, infantile, or childhood fibrosarcoma treated with neoadjuvant
chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC) before
definitive local control.

Secondary

- Determine the event-free and relapse-free survival of patients initially treated with
this regimen followed by observation after local control with positive microscopic
margins.

- Determine the event-free and relapse-free survival of patients initially treated with
this regimen followed by additional chemotherapy comprising etoposide and ifosfamide
after local control with gross positive margins.

- Determine the event-free and relapse-free survival of patients treated with surgery
alone.

OUTLINE: This is a pilot, multicenter study. Patients begin treatment according to lesion
resectability.

Patients with resectable lesions proceed to surgery.

- Surgery: Patients undergo resection of disease lesions. Patients with clear or
microscopically positive margins undergo observation only. Patients with grossly
positive margins undergo re-resection if feasible. Patients with grossly positive
margins after re-resection or for whom re-resection is not feasible receive
chemotherapy comprising vincristine, dactinomycin, and cyclophosphamide (VAC).

Patients with unresectable lesions receive VAC chemotherapy.

- VAC chemotherapy: Patients receive vincristine IV on days 1, 8, and 15 and dactinomycin
IV and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 21 days for up
to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with disease progression after 2-4 courses of VAC chemotherapy proceed to
chemotherapy comprising etoposide and ifosfamide (IE).

Patients with stable disease after 4 courses of VAC chemotherapy proceed to IE chemotherapy.

Patients with a partial response (PR) and unresectable lesions after 4 courses of VAC
chemotherapy receive 2 additional courses of VAC and are then re-evaluated. Patients proceed
to surgery if they continue to have a PR or achieve a complete response (CR) and lesions are
now resectable.

Patients with a CR or PR and resectable lesions after 4 courses of VAC chemotherapy proceed
to surgery.

Patients with stable disease, progressive disease, or a PR and unresectable lesions after 6
courses of VAC proceed to IE chemotherapy.

- IE chemotherapy: Patients receive etoposide IV over 1 hour and ifosfamide IV over 1
hour on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

Patients with a CR or PR and resectable lesions after 2-4 courses of IE chemotherapy proceed
to surgery.

All patients are followed every 3 months for 6 months, every 6 months for 1 year, and then
as clinically indicated.

PROJECTED ACCRUAL: A total of 60-70 patients will be accrued for this study within 8 years.

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

- ECOG 0-2

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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Mignon Loh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

ARST03P1

NCT ID:

NCT00072280

Start Date:

November 2004

Completion Date:

June 2008

Related Keywords:

  • Sarcoma
  • childhood fibrosarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • Fibrosarcoma
  • Sarcoma

Name

Location

Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Children's Mercy HospitalKansas City, Missouri  64108
All Children's HospitalSt. Petersburg, Florida  33701
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Children's Hospitals and Clinics of MinneapolisMinneapolis, Minnesota  55404
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Columbus Children's HospitalColumbus, Ohio  43205-2696
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
OU Cancer InstituteOklahoma City, Oklahoma  73104
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305