Clinical Trial: Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Trial of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma

Brief Summary: Bortezomib will enhance the activity of dacarbazine against melanoma and soft tissue sarcoma. Weekly administration of the combination will prove to be feasible and tolerable at an appropriate dose.

Detailed Summary:

The primary objective is to determine recommended phase II doses for the combination dacarbazine and bortezomib administered weekly.

Secondary objectives are to determine the maximum tolerated dose combination and to observe anti-tumor activity in terms of response rate(s), duration of response, time to progression, and time on treatment (a measure of both antitumor activity and treatment tolerance).

Sponsor: Virginia Commonwealth University

Current Primary Outcome: Safety as measured by serious adverse events [ Time Frame: 4 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Virginia Commonwealth University

Dates:
Date Received: December 18, 2007
Date Started: September 2004
Date Completion:
Last Updated: August 17, 2016
Last Verified: August 2016