rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shenzhen SiBiono GeneTech Co.,Ltd
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier:
NCT00902122
First received: May 12, 2009
Last updated: April 6, 2012
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Malignant Thyroid Tumors |
Drug: rAd-p53 gene Procedure: surgery Drug: p53 gene therapy Radiation: p53 gene therapy with radioactive iodine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Shenzhen SiBiono GeneTech Co.,Ltd:
Primary Outcome Measures:
- Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progress-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 600 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
surgery
|
Procedure: surgery
removal of thyroid tumor
|
|
Experimental: 3
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Advanced stages of thyroid malignant tumors (stage III and VI)
- At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
- Histologically confirmed Oral and Maxillofacial malignant tumors
- No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
- Age: 18-85 years old
- Expected to survive more 12 weeks
- ECOG:0-2
- Neutrophils≥1.5×109/L,Platelet≥ 80×109/L, Hb≥80g/L, bilitubin≤2mg/dl,ALT and AST ≤2×institutional upper limit of normal, Cr ≤1.5×institutional upper limit of normal,coagulation tests (PTT and INR) within normal range
- Subject provided signed informed consent -
Exclusion Criteria:
- Hypersensitive to study drug
- Tumor(s) locate very close to important blood vessels and nerves, which affect injection
- With a coagulation and bleeding disorder
- With uncontrolled, intercurrent illness including but limited to symptomatic neurological illness, symptomatic congestive heart failure, unstable angina pectoris, significant pulmonary disease or hypoxia, or psychiatric illness
- Local infection close to injection site or systemic infection
- Pregnant or lactating
- Principle investigator consider not suitable
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902122
Contacts
| Contact: aiqi wang, MD | 86-755-33065218 | aiqi.wang@sibiono.com |
Locations
| China, Sichuan | |
| West China Hospital, Sichuan University | Recruiting |
| Chengdu, Sichuan, China, 610002 | |
| Contact: Jingqiang Zhu, PhD, MD 86-28-81812477 zjq-wkys@163.com | |
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
Investigators
| Principal Investigator: | Jingqiang Zhu, MD,PhD | Department Of Thyroid and breast Surgery, West China hospital, Sichuan University |
More Information
No publications provided
| Responsible Party: | Shenzhen SiBiono GeneTech Co.,Ltd |
| ClinicalTrials.gov Identifier: | NCT00902122 History of Changes |
| Other Study ID Numbers: | rAd-p53-003 |
| Study First Received: | May 12, 2009 |
| Last Updated: | April 6, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
|
p53 gene thyroid gene therapy malignant tumors |
Additional relevant MeSH terms:
|
Li-Fraumeni Syndrome Thyroid Neoplasms Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Endocrine System Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders |
Metabolic Diseases Iodine Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013