rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

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”

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.

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • p53 gene therapy before surgery
• Active Comparator: 2
  • surgery
• Experimental: 3
  • p53 gene therapy
• Active Comparator: 4
  • p53 gene therapy plus radioactive iodine

Primary Measures

• Overall Response Rate
  • Time Frame: 3 years
    Safety Issue?: No

Secondary Measures

• Progress-free survival
  • Time Frame: 3 years
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Shenzhen SiBiono GeneTech Co.,Ltd Industry

Overall Clinical Trial Officials and Contacts

Jingqiang Zhu, MD,PhD Principal Investigator Department Of Thyroid and breast Surgery, West China hospital, Sichuan University  

Overall Contact: aiqi wang, MD 86-755-33065218 aiqi.wang@sibiono.com

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00902122

Study ID Number: rAd-p53-003

ClinicalTrials.gov Identifier: NCT00902122

Health Authority: China: State Food and Drug Administration