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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


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
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