Clinical Trial: Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Phase II Study of Brentuximab Vedotin and Bevacizumab in Men With Refractory CD-30 Positive Germ Cell Tumors
Brief Summary: This is a multi-center phase II study of brentuximab vedotin in combination with bevacizumab for the treatment of refractory CD-30+ germ cell tumors (GCT) after disease progression on imaging and/or tumor marker progression documented by serially rising alpha-fetoprotein (AFP) or beta human chorionic gonadotropin (bHCG) measured on at least 2 consecutive visits and determined by treating physician to be clinically significant. Patients unable to receive 2nd line of platinum-based chemotherapy due to toxicity or refusal would also be eligible.
Detailed Summary:
Sponsor: Masonic Cancer Center, University of Minnesota
Current Primary Outcome: Disease response rate as defined by the RECIST 1.1 criteria, integrated with tumor marker response. [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Progression free survival [ Time Frame: 1 year ]
- Overall survival [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: Masonic Cancer Center, University of Minnesota
Dates:
Date Received: December 1, 2016
Date Started: March 29, 2017
Date Completion: February 2021
Last Updated: May 1, 2017
Last Verified: May 2017
