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Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00062205
Recruitment Status : Completed
First Posted : June 6, 2003
Last Update Posted : February 9, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
City of Hope Medical Center

Tracking Information
First Submitted Date  ICMJE June 5, 2003
First Posted Date  ICMJE June 6, 2003
Last Update Posted Date February 9, 2010
Study Start Date  ICMJE June 2002
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Response rate as measured by RECIST criteria
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2007)
Progression-free survival at 6 months
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor
Official Title  ICMJE Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors
Brief Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.

Detailed Description

OBJECTIVES:

  • Determine the effectiveness of imatinib mesylate in patients with recurrent Ewing's family of tumors or desmoplastic small round-cell tumor.
  • Determine the toxic effects of this drug in these patients.
  • Determine the duration of disease-free and overall survival of patients treated with this drug.

OUTLINE: This is an open-label study.

Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcoma
Intervention  ICMJE Drug: imatinib mesylate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 20, 2007)
40
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of Ewing's family of tumors OR desmoplastic small round-cell tumor
  • Must have immunohistochemical evidence of expression of greater than 2+/4+ for either Kit (CD117) or platelet-derived growth factor receptor -a or -b
  • No symptomatic brain metastases

    • Asymptomatic brain metastases are allowed provided patient is not on concurrent anticonvulsants or corticosteroids

PATIENT CHARACTERISTICS:

Age

  • Over 16

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 9 g/dL

Hepatic

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT less than 2.5 times ULN
  • No chronic active hepatitis
  • No cirrhosis
  • No other acute or known chronic liver disease

Renal

  • Creatinine less than 1.5 times ULN

Cardiovascular

  • No concurrent poorly controlled or severe cardiovascular disease

Pulmonary

  • No concurrent poorly controlled or severe pulmonary disease

Other

  • HIV negative
  • No concurrent poorly controlled or severe central nervous system disease
  • No other concurrent poorly controlled or severe nonmalignant disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • At least 3 weeks since prior chemotherapy

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • At least 3 weeks since prior radiotherapy

Surgery

  • More than 2 weeks since prior major surgery

Other

  • More than 28 days since prior investigational agents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00062205
Other Study ID Numbers  ICMJE CDR0000304551
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-IRB-02008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Warren Chow MD, City of Hope Medical Center
Study Sponsor  ICMJE City of Hope Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE Not Provided
PRS Account City of Hope Medical Center
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP