rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
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|ClinicalTrials.gov Identifier: NCT00902122|
Recruitment Status : Unknown
Verified February 2010 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was: Recruiting
First Posted : May 14, 2009
Last Update Posted : April 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Thyroid Tumors||Drug: rAd-p53 gene Procedure: surgery Drug: p53 gene therapy Radiation: p53 gene therapy with radioactive iodine||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
Drug: rAd-p53 gene
pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
Active Comparator: 2
removal of thyroid tumor
p53 gene therapy
Drug: p53 gene therapy
p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
Active Comparator: 4
p53 gene therapy plus radioactive iodine
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
- Overall Response Rate [ Time Frame: 3 years ]
- Progress-free survival [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902122
|Contact: aiqi wang, MDfirstname.lastname@example.org|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, 610002|
|Contact: Jingqiang Zhu, PhD, MD 86-28-81812477 email@example.com|
|Principal Investigator:||Jingqiang Zhu, MD,PhD||Department Of Thyroid and breast Surgery, West China hospital, Sichuan University|