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

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

City of Hope Medical Center

ClinicalTrials.gov Identifier:

NCT00062205

First received: June 5, 2003

Last updated: February 5, 2010

Last verified: February 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 5, 2003
Last Updated Date	February 5, 2010
Start Date ^ICMJE	June 2002
Primary Completion Date	June 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 25, 2007)	Response rate as measured by RECIST criteria [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00062205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 25, 2007)	Progression-free survival at 6 months [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 2
Study Design ^ICMJE	Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Sarcoma
Intervention ^ICMJE	Drug: imatinib mesylate
Study Arm (s)	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	40
Completion Date	June 2007
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
Gender	Both
Ages	16 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	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, CHNMC-IRB-02008
Has Data Monitoring Committee	Not Provided
Plan to Share Data	Not Provided
IPD Description	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
Information Provided By	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

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