rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors

Phase 4

• Conditions: Advanced Oral and Maxillofacial Malignant Tumors
• Interventions: Drug: p53 gene with surgery; Procedure: surgery; Drug: p53 with chemotherapy; Drug: p53 gene therapy

• Registration Number: NCT00902083
• 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 chemotherapy , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

Detailed Description

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant 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 chemotherapy,or surgery.

Study Timeline

• Study First Submitted: 2009-05-11
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-14
• Study Start: 2009-06
• Status Verified: 2010-02
• Last Update Submitted: 2012-04-06
• Last Update Posted: 2012-04-09
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

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

Inclusion Criteria

1. Advanced stages of Oral and Maxillofacial 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
surgery plus p53 gene	p53 gene with surgery	using p53 gene therapy before surgery
surgery alone	surgery	Surgery without pre-p53 gene therapy
p53 plus chemotherapy	p53 with chemotherapy	p53 gene therapy with concurrent chemotherapy
p53 gene therapy alone	p53 gene therapy	Intra-tumor injectio of rAd-p53 gene with no concurrent treatment

Primary Outcome Measures

Name	Time	Method
overall best 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