rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
Conditions
Advanced Malignant Thyroid Tumors
Conditions: official terms
Thyroid Diseases - Thyroid Neoplasms
Conditions: Keywords
p53 gene, thyroid, gene therapy, malignant tumors
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: rAd-p53 gene Type: Drug
Name: surgery Type: Procedure
Name: p53 gene therapy Type: Drug
Name: p53 gene therapy with radioactive iodine Type: Radiation
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
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
Location
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Status: Recruiting
Contact: Jingqiang Zhu, PhD, MD - 86-28-81812477 - zjq-wkys@163.com
Start Date
May 2009
Completion Date
August 2012
Sponsors
Shenzhen SiBiono GeneTech Co.,Ltd
Source
Shenzhen SiBiono GeneTech Co.,Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page