Expired Study
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Duarte, California 91010


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00062205


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Duarte, California 91010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 13, 2017

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