rAd-p53 Gene Therapy for Advanced Malignant Thyroid Tumors

Phase 4

• Conditions: Advanced Malignant Thyroid Tumors
• Interventions: Drug: rAd-p53 gene; Procedure: surgery; Drug: p53 gene therapy; Radiation: p53 gene therapy with radioactive iodine

• Registration Number: NCT00902122
• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-12
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Status Verified: 2010-02
• Last Update Submitted: 2012-04-06
• Last Update Posted: 2012-04-09
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	rAd-p53 gene	Five times of p53 gene intratumoral injection are given before surgery,then radical surgery will be conducted.
2	surgery	surgery
3	p53 gene therapy	p53 gene therapy
4	p53 gene therapy with radioactive iodine	p53 gene therapy plus radioactive iodine

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	3 years

Secondary Outcome Measures

Name	Time	Method
Progress-free survival	3 years

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China