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
  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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014