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

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	Complete list of historical versions of study NCT00062205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 20, 2007)	Progression-free survival at 6 months
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: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Sarcoma
Intervention ICMJE	Drug: imatinib mesylate
Study Arms	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	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	Sexes Eligible for Study: All
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 ( U.S. NIH Grant/Contract ); CHNMC-IRB-02008
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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