Sarcoma
Conditions
Keywords
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate as measured by RECIST criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival at 6 months | — |
Countries
United States