Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, non-comparative study conducted to investigate the activity and safety of imatinib mesylate in refractory desmoplastic small round cell tumors expressing PDGF-R. Patients will be treated up to 12 months, or to disease progression. Tumor will be evaluated according to Recist criteria

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

Inclusion criteria:

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

Exclusion criteria:

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 study

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 progressing.

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.