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Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma


Phase 2
N/A
30 Years
Not Enrolling
Both
Sarcoma

Thank you

Trial Information

Phase II Trial of Intermediate-Dose Cytarabine to Modulate EWS/FLI for Children and Young Adults With Recurrent or Refractory Ewing Sarcoma


OBJECTIVES:

- Determine the response rate in younger patients with recurrent or refractory Ewing's
sarcoma treated with cytarabine.

OUTLINE: This is a multicenter study.

Patients receive cytarabine IV over 2 hours twice daily on days 1-5. Treatment repeats every
21 days for up to 11 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed Ewing's sarcoma or primitive neuroectodermal tumor (PNET)

- Disease that has recurred or not responded despite prior therapy

- Has declined enrollment on or is not eligible for clinical trial COG-AEWS0521

- Must have at least one site of measurable disease involving lung or soft tissue as
documented by CT scan and/or MRI

- No disease limited to bone

PATIENT CHARACTERISTICS:

- Karnofsky performance status (PS) 50-100% (for patients > 16 years of age) OR Lansky
PS 50-100% (for patients ≤ 16 years of age)

- Life expectancy ≥ 8 weeks

- ANC ≥ 750/mm^3

- Platelet count ≥ 75,000/mm^3 (50,000/mm^3 if documented bone marrow metastatic
disease) (transfusion independent)

- Hemoglobin ≥ 8.0 g/dL (red blood cell transfusions allowed)

- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age and < 2.0 mg/dL

- ALT ≤ 2.5 times ULN

- Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR creatinine meeting the
following criteria:

- ≤ 0.4 mg/dL (1 month to < 6 months of age)

- ≤ 0.5 mg/dL (6 months to < 1 year of age)

- ≤ 0.6 mg/dL (1 to < 2 years of age)

- ≤ 0.8 mg/dL (2 to < 6 years of age)

- ≤ 1.0 mg/dL (6 to < 10 years of age)

- ≤ 1.2 mg/dL (10 to < 13 years of age)

- ≤ 1.4 mg/dL (≥ 13 years of age) (female)

- ≤ 1.5 mg/dL (13 to < 16 years of age) (male)

- ≤ 1.7 mg/dL (≥ 16 years of age) (male)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection, including systemic fungal infections requiring ongoing
antifungal therapy

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from all prior tumor-directed therapy

- At least 7 days since prior biologic therapy or immunotherapy

- At least 1 week since prior hematopoietic growth factors (2 weeks for pegfilgrastim)

- At least 2 weeks since prior myelosuppressive chemotherapy

- At least 2 weeks since prior local palliative (small-port) radiotherapy

- At least 6 weeks since prior substantial bone marrow radiotherapy

- At least 6 months since prior radiotherapy to ≥ 50% of the pelvis

- At least 6 months since prior autologous stem cell transplantation

- No prior allogeneic stem cell transplantation

- No prior cytarabine

- No other concurrent investigational agents, including chemotherapy, immunotherapy, or
biologic therapy

- No other concurrent anticancer chemotherapy or immunomodulating agents

- Concurrent corticosteroids allowed

- No concurrent intrathecal chemotherapy

- Concurrent radiotherapy to localized painful lesions allowed provided at least one
measurable lesion is not irradiated (no irradiated lesion may be used to assess tumor
response)

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Kimberly Stegmaier, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000542650

NCT ID:

NCT00470275

Start Date:

May 2007

Completion Date:

Related Keywords:

  • Sarcoma
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Hurley Medical CenterFlint, Michigan  48503
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Hospital of Orange CountyOrange, California  92668
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Children's Medical Center - DaytonDayton, Ohio  45404
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
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
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Akron Children's HospitalAkron, Ohio  44308-1062
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Columbus Children's HospitalColumbus, Ohio  43205-2696
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Greenville Hospital Cancer CenterGreenville, South Carolina  29605
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint LouisSt Louis, Missouri  63110