NCT00902083

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

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 With Advanced Oral and Maxillofacial Malignant Tumors

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Advanced Oral and Maxillofacial Malignant Tumors

Interventions

Type	Name	Description
DRUG	p53 gene with surgery	pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
PROCEDURE	surgery	remove tumor surgery
DRUG	p53 with chemotherapy	p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy
DRUG	p53 gene therapy	p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

Timeline

• Start date: 2009-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-05-14
• Last updated: 2012-04-09

Locations

1 site across 1 country: China