Cytarabine in Treating Young Patients With Recurrent or Refractory Ewing's Sarcoma

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00470275
• Other study ID #: AEWS0621
• Secondary ID: CDR0000542650COG
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2007
• Last updated: October 9, 2014
• Start date: May 2007
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well cytarabine works in treating young patients with recurrent or refractory Ewing's sarcoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2013
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma, Ewing

Intervention

Drug:
• cytarabine
Given IV

Locations

Country	Name	City	State
Australia	Princess Margaret Hospital for Children	Perth	Western Australia
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario
Canada	Hopital Sainte Justine	Montreal	Quebec
Canada	Montreal Children's Hospital at McGill University Health Center	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec
Canada	Hospital for Sick Children	Toronto	Ontario
Puerto Rico	San Jorge Children's Hospital	Santurce
United States	Akron Children's Hospital	Akron	Ohio
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana
United States	Texas Tech University Health Sciences Center School of Medicine - Amarillo	Amarillo	Texas
United States	C.S. Mott Children's Hospital at University of Michigan Medical Center	Ann Arbor	Michigan
United States	Alvin and Lois Lapidus Cancer Institute at Sinai Hospital	Baltimore	Maryland
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	West Virginia University Health Sciences Center - Charleston	Charleston	West Virginia
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Children's Memorial Hospital - Chicago	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Palmetto Health South Carolina Cancer Center	Columbia	South Carolina
United States	Columbus Children's Hospital	Columbus	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Children's Medical Center - Dayton	Dayton	Ohio
United States	Southern California Permanente Medical Group	Downey	California
United States	Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center	Farmington	Connecticut
United States	Hurley Medical Center	Flint	Michigan
United States	Lee Cancer Care of Lee Memorial Health System	Fort Myers	Florida
United States	Cook Children's Medical Center - Fort Worth	Fort Worth	Texas
United States	Butterworth Hospital at Spectrum Health	Grand Rapids	Michigan
United States	Greenville Hospital Cancer Center	Greenville	South Carolina
United States	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Cancer Research Center of Hawaii	Honolulu	Hawaii
United States	Baylor University Medical Center - Houston	Houston	Texas
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Indiana University Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	University of Mississippi Cancer Clinic	Jackson	Mississippi
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	East Tennessee Children's Hospital	Knoxville	Tennessee
United States	Sunrise Hospital and Medical Center	Las Vegas	Nevada
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Children's Hospital Central California	Madera	California
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin
United States	Midwest Children's Cancer Center	Milwaukee	Wisconsin
United States	Overlook Hospital	Morristown	New Jersey
United States	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	New York	New York
United States	NYU Cancer Institute at New York University Medical Center	New York	New York
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Children's Hospital of Orange County	Orange	California
United States	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	Oregon
United States	Rhode Island Hospital Comprehensive Cancer Center	Providence	Rhode Island
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Methodist Children's Hospital of South Texas	San Antonio	Texas
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Children's Hospital and Regional Medical Center - Seattle	Seattle	Washington
United States	Simmons Cooper Cancer Institute	Springfield	Illinois
United States	Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis	St. Louis	Missouri
United States	All Children's Hospital	St. Petersburg	Florida
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	St. Joseph's Cancer Institute at St. Joseph's Hospital	Tampa	Florida
United States	Arizona Cancer Center at University of Arizona Health Sciences Center	Tucson	Arizona
United States	Lombardi Comprehensive Cancer Center at Georgetown University Medical Center	Washington	District of Columbia
United States	Kaplan Cancer Center at St. Mary's Medical Center	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Puerto Rico, 

References & Publications (1)

DuBois SG, Krailo MD, Lessnick SL, Smith R, Chen Z, Marina N, Grier HE, Stegmaier K; Children's Oncology Group. Phase II study of intermediate-dose cytarabine in patients with relapsed or refractory Ewing sarcoma: a report from the Children's Oncology Gro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	Any patient who is enrolled and receives at least one dose of cytarabine will be considered evaluable for response if (1) the patient demonstrates progressive disease while on protocol therapy or (2) the patient is observed on protocol therapy for at least one cycle. Patients who achieve a complete or partial response according to the RECIST (Response Evaluation Criteria In Solid Tumors) criteria will be considered responders for the study design. All other patients who are evaluable for response will be considered non-responders for the study.	the first six cycles of study chemotherapy (126 days)	No