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
Sponsor:
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

May 12, 2009
April 6, 2012
May 2009
August 2012   (final data collection date for primary outcome measure)
Overall Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00902122 on ClinicalTrials.gov Archive Site
Progress-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Malignant Thyroid Tumors
  • 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
  • Experimental: 1
    Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
    Intervention: Drug: rAd-p53 gene
  • Active Comparator: 2
    surgery
    Intervention: Procedure: surgery
  • Experimental: 3
    p53 gene therapy
    Intervention: Drug: p53 gene therapy
  • Active Comparator: 4
    p53 gene therapy plus radioactive iodine
    Intervention: Radiation: p53 gene therapy with radioactive iodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact: aiqi wang, MD 86-755-33065218 aiqi.wang@sibiono.com
China
 
NCT00902122
rAd-p53-003
No
Shenzhen SiBiono GeneTech Co.,Ltd
Shenzhen SiBiono GeneTech Co.,Ltd
Not Provided
Principal Investigator: Jingqiang Zhu, MD,PhD Department Of Thyroid and breast Surgery, West China hospital, Sichuan University
Shenzhen SiBiono GeneTech Co.,Ltd
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP