Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor
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ClinicalTrials.gov Identifier: NCT00062205 |
Recruitment Status
:
Completed
First Posted
: June 6, 2003
Last Update Posted
: February 9, 2010
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Tracking Information | |||
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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 |
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 |
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. |
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Detailed Description | OBJECTIVES:
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. |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Masking: None (Open Label) Primary Purpose: Treatment |
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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. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Estimated Enrollment ICMJE |
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:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Sex/Gender |
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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 |
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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 |