Clinical Trial: rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects

Brief Summary: This is multicenter, open-label, randomized, active-controled, phase IV study of local direct intra-tumor injection of rAd-p53 monotherapy, with concurrent chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

Detailed Summary:

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors(stage III or IV) including target lesion complete response rate (LCR) and overall target lesion response rate (OLR), response duration (RD), and progress-free survival (PFS).

The secondary objectives of this study is to investigate overall response rate (OPCR) and overall complete response rate (OCR), overall survival (OS), ECOG, and safety of rAd-p53 monotherapy and combined with chemotherapy,or surgery.

Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Current Primary Outcome: overall best response rate [ Time Frame: 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: progress free survival [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: Shenzhen SiBiono GeneTech Co.,Ltd

Dates:
Date Received: May 11, 2009
Date Started: June 2009
Date Completion: July 2012
Last Updated: April 6, 2012
Last Verified: February 2010