Clinical Trial: Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open-label Trial of Imatinib Mesylate in Patients With Refractory Desmoplastic Small Round Cell Tumors (DSRCT) Expressing PDGF-R
Brief 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
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Overall tumor response rates [ Time Frame: Assessed every 3 months ]
Original Primary Outcome: objective response rates
Current Secondary Outcome:
- Explore how Imatinib cooperated with other treatment modatilities [ Time Frame: Survival data was collected until death ]Recorded survival after treatment and other associated treatment modalities.
- Safety and tolerability [ Time Frame: Safety data collected until patients were no longer in study ]
- Conversion rate to surgical resectability [ Time Frame: After best tumor response. ]Assessed actual resectability rate after therapy compared to resectability before therapy.
- Mutational analysis of molecular targets of imatinib (at any time during the study) [ Time Frame: At any time during the study ]
Original Secondary Outcome:
- overall survival
- Safety and tolerability
- conversion rate to surgical respectability
- Mutational analysis of molecular targets of imatinib (at any time during the study)
Information By: Novartis
Dates:
Date Received: January 2, 2007
Date Started: August 2005
Date Completion:
Last Updated: December 23, 2010
Last Verified: December 2010