NCT00902122

rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Radioactive Iodine , or Combination With Surgery in Subjects With Advanced Malignant Thyroid 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 radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

Detailed description

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with with concurrent radioactive iodine, or combination with surgery for treatment of advanced malignant thyroid 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 radioactive iodine,or surgery.

Conditions

• Advanced Malignant Thyroid Tumors

Interventions

Type	Name	Description
DRUG	rAd-p53 gene	pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
PROCEDURE	surgery	removal of thyroid tumor
DRUG	p53 gene therapy	p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
RADIATION	p53 gene therapy with radioactive iodine	p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-05-14
• Last updated: 2012-04-09

Locations

1 site across 1 country: China