Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R
1. Patients > 16 years of age.
2. Histologically documented diagnosis of DSRCT, unresponsive or in no complete
remission after any conventional multimodality approach.
3. Immunohistochemical documentation of activated PDGF-R expression by tumor
4. At least one measurable site of disease
5. Performance status 0,1, 2 or 3 (Eastern Cooperative Oncology Group)
6. Adequate end organ function
1. Patient has received any other investigational agents within 28 days of first day of
study drug dosing, unless the disease is rapidly progressing.
2. Patient is < 5 years free of another primary malignancy
3. Patient with congestive heart failure or myocardial infarction within 6 months of
4. Female patients who are pregnant or breast-feeding.
5. Severe and/or uncontrolled medical disease
6. Known brain metastasis.
7. Chronic active hepatitis or cirrhosis
8. Known diagnosis of human immunodeficiency virus (HIV) infection.
9. Chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly
10. Previous radiotherapy to > 25 % of the bone marrow
11. Major surgery within 2 weeks prior to study entry.
Other protocol defined inclusion/exclusion criteria may apply.