rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

NCT ID: NCT00902122

Last Updated: 2012-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-08-31

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.

Conditions

Advanced Malignant Thyroid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.

Group Type: EXPERIMENTAL

rAd-p53 gene

Intervention Type: DRUG

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

2

surgery

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: PROCEDURE

removal of thyroid tumor

3

p53 gene therapy

Group Type: EXPERIMENTAL

p53 gene therapy

Intervention Type: DRUG

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

4

p53 gene therapy plus radioactive iodine

Group Type: ACTIVE_COMPARATOR

p53 gene therapy with radioactive iodine

Intervention Type: RADIATION

p53 gene therapy with concurrent radioactive iodine pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

Interventions

rAd-p53 gene

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

Intervention Type: DRUG

surgery

removal of thyroid tumor

Intervention Type: PROCEDURE

p53 gene therapy

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

Intervention Type: DRUG

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

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen SiBiono GeneTech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingqiang Zhu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Department Of Thyroid and breast Surgery, West China hospital, Sichuan University

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

aiqi wang, MD

Role: CONTACT

aiqi.wang@sibiono.com

86-755-33065218

Facility Contacts

Jingqiang Zhu, PhD, MD

Role: primary

zjq-wkys@163.com

86-28-81812477

Other Identifiers

rAd-p53-003

Identifier Type: -

Identifier Source: org_study_id