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rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd

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 radioactive iodine , or combination with surgery for treatment of advanced malignant thyroid tumors.

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : May 2009
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
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

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Progress-free survival [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Advanced stages of thyroid malignant tumors (stage III and VI)
  2. At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
  3. Histologically confirmed Oral and Maxillofacial malignant tumors
  4. No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
  5. Age: 18-85 years old
  6. Expected to survive more 12 weeks
  7. ECOG:0-2
  8. 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
  9. Subject provided signed informed consent -

Exclusion Criteria:

  1. Hypersensitive to study drug
  2. Tumor(s) locate very close to important blood vessels and nerves, which affect injection
  3. With a coagulation and bleeding disorder
  4. 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
  5. Local infection close to injection site or systemic infection
  6. Pregnant or lactating
  7. Principle investigator consider not suitable

Information from the National Library of Medicine

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 identifier (NCT number): NCT00902122

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Contact: aiqi wang, MD 86-755-33065218

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China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610002
Contact: Jingqiang Zhu, PhD, MD    86-28-81812477   
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
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Principal Investigator: Jingqiang Zhu, MD,PhD Department Of Thyroid and breast Surgery, West China hospital, Sichuan University

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Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd Identifier: NCT00902122     History of Changes
Other Study ID Numbers: rAd-p53-003
First Posted: May 14, 2009    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: February 2010
Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53 gene
gene therapy
malignant tumors
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Growth Substances
Physiological Effects of Drugs