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 ]

An imaging technique (CT scan or MRI) determined tumor response according to RECIST criteria.


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