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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Gleevec (STI571) in Therapy of Ewing's Family of Tumors and Desmoplastic Small Round Cell Tumors

Conditions
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Sarcoma

Intervention / Treatment
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* Drug: imatinib mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imatinib mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate as measured by RECIST criteria |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival at 6 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor