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

October 9, 2014 updated by: Children's Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Princess Margaret Hospital for Children
  • Canada
      • Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Québec
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Center
      • Montreal, Quebec, Canada, H3T 1C5
        • Hopital Sainte Justine
  • Puerto Rico
      • Santurce, Puerto Rico, 00912
        • San Jorge Children's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724-5024
        • Arizona Cancer Center at University of Arizona Health Sciences Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Downey, California, United States, 90242-2814
        • Southern California Permanente Medical Group
      • Madera, California, United States, 93638-8762
        • Children's Hospital Central California
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Connecticut
      • Farmington, Connecticut, United States, 06360-2875
        • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Lee Cancer Care of Lee Memorial Health System
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Cancer Institute at St. Joseph's Hospital
      • West Palm Beach, Florida, United States, 33407
        • Kaplan Cancer Center at St. Mary's Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Cancer Research Center of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital - Chicago
      • Springfield, Illinois, United States, 62794-9677
        • Simmons Cooper Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Louisiana
      • Alexandria, Louisiana, United States, 71315-3198
        • Tulane Cancer Center Office of Clinical Research
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0286
        • C.S. Mott Children's Hospital at University of Michigan Medical Center
      • Flint, Michigan, United States, 48503
        • Hurley Medical Center
      • Grand Rapids, Michigan, United States, 49503-2560
        • Butterworth Hospital at Spectrum Health
    • Mississippi
      • Jackson, Mississippi, United States, 39216-4505
        • University of Mississippi Cancer Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • St. Louis, Missouri, United States, 63110
        • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
    • Nevada
      • Las Vegas, Nevada, United States, 89109-2306
        • Sunrise Hospital and Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center Cancer Center
      • Morristown, New Jersey, United States, 07962
        • Overlook Hospital
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-5636
        • University of New Mexico Cancer Center
    • New York
      • New York, New York, United States, 10016
        • NYU Cancer Institute at New York University Medical Center
      • New York, New York, United States, 10032
        • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
      • Stony Brook, New York, United States, 11794-9446
        • Stony Brook University Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • Charlotte, North Carolina, United States, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
    • Ohio
      • Akron, Ohio, United States, 44308-1062
        • Akron Children's Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5000
        • Rainbow Babies and Children's Hospital
      • Columbus, Ohio, United States, 43205-2696
        • Columbus Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • Children's Medical Center - Dayton
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma University Cancer Institute
    • Oregon
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Cancer Institute at Milton S. Hershey Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital Comprehensive Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, United States, 29605
        • Greenville Hospital Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37901
        • East Tennessee Children's Hospital
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Tech University Health Sciences Center School of Medicine - Amarillo
      • Dallas, Texas, United States, 75390
        • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center - Fort Worth
      • Houston, Texas, United States, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Houston, Texas, United States, 77030-2399
        • Baylor University Medical Center - Houston
      • San Antonio, Texas, United States, 78229-3993
        • Methodist Children's Hospital of South Texas
    • Utah
      • Salt Lake City, Utah, United States, 84113-1100
        • Primary Children's Medical Center
    • Virginia
      • Norfolk, Virginia, United States, 23507-1971
        • Children's Hospital of The King's Daughters
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center - Seattle
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • West Virginia University Health Sciences Center - Charleston
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center
      • Milwaukee, Wisconsin, United States, 53226
        • Midwest Children's Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cytarbine
Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
Drug: cytarabine
Given IV
Other Names:
  • Ara-C
  • Cytosar
  • cytosine arabinoside
  • NSC #063878

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response
Time Frame: the first six cycles of study chemotherapy (126 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Kimberly Stegmaier, MD, Dana-Farber Cancer Institute
  • Principal Investigator: Holcombe E. Grier, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 3, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 7, 2007

Study Record Updates

Last Update Posted (Estimate)

October 20, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEWS0621
  • CDR0000542650 (Other Identifier: Clinical Trials.gov)
  • COG-AEWS0621 (Other Identifier: Children's Oncology Group)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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