Back to resultsrAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
Primary Purpose
Advanced Malignant Thyroid Tumors
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rAd-p53 gene
surgery
p53 gene therapy
p53 gene therapy with radioactive iodine
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Malignant Thyroid Tumors focused on measuring p53 gene, thyroid, gene therapy, malignant tumors
Eligibility Criteria
Inclusion Criteria:
- Advanced stages of thyroid malignant tumors (stage III and VI)
- At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
- Histologically confirmed Oral and Maxillofacial malignant tumors
- No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
- Age: 18-85 years old
- Expected to survive more 12 weeks
- ECOG:0-2
- 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
- Subject provided signed informed consent -
Exclusion Criteria:
- Hypersensitive to study drug
- Tumor(s) locate very close to important blood vessels and nerves, which affect injection
- With a coagulation and bleeding disorder
- 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
- Local infection close to injection site or systemic infection
- Pregnant or lactating
- Principle investigator consider not suitable
Sites / Locations
- West China Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
surgery
p53 gene therapy
p53 gene therapy plus radioactive iodine
Outcomes
Primary Outcome Measures
Overall Response Rate
Secondary Outcome Measures
Progress-free survival
Full Information
NCT ID
NCT00902122
First Posted
May 12, 2009
Last Updated
April 6, 2012
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00902122
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Thyroid Tumors
Keywords
p53 gene, thyroid, gene therapy, malignant tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
Arm Title
2
Arm Type
Active Comparator
Arm Description
surgery
Arm Title
3
Arm Type
Experimental
Arm Description
p53 gene therapy
Arm Title
4
Arm Type
Active Comparator
Arm Description
p53 gene therapy plus radioactive iodine
Intervention Type
Drug
Intervention Name(s)
rAd-p53 gene
Intervention Description
pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
Intervention Type
Procedure
Intervention Name(s)
surgery
Intervention Description
removal of thyroid tumor
Intervention Type
Drug
Intervention Name(s)
p53 gene therapy
Intervention Description
p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
Intervention Type
Radiation
Intervention Name(s)
p53 gene therapy with radioactive iodine
Intervention Description
p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progress-free survival
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced stages of thyroid malignant tumors (stage III and VI)
At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
Histologically confirmed Oral and Maxillofacial malignant tumors
No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
Age: 18-85 years old
Expected to survive more 12 weeks
ECOG:0-2
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
Subject provided signed informed consent -
Exclusion Criteria:
Hypersensitive to study drug
Tumor(s) locate very close to important blood vessels and nerves, which affect injection
With a coagulation and bleeding disorder
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
Local infection close to injection site or systemic infection
Pregnant or lactating
Principle investigator consider not suitable
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
aiqi wang, MD
Phone
86-755-33065218
Email
aiqi.wang@sibiono.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingqiang Zhu, MD,PhD
Organizational Affiliation
Department Of Thyroid and breast Surgery, West China hospital, Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingqiang Zhu, PhD, MD
Phone
86-28-81812477
Email
zjq-wkys@163.com
12. IPD Sharing Statement
Learn more about this trial
rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors
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