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

NCT ID: NCT00902083

Last Updated: 2012-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-07-31

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 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.

Conditions

Advanced Oral and Maxillofacial Malignant Tumors

Study Design

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

Study Groups

surgery plus p53 gene

using p53 gene therapy before surgery

Group Type: EXPERIMENTAL

p53 gene with surgery

Intervention Type: DRUG

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

surgery alone

Surgery without pre-p53 gene therapy

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: PROCEDURE

remove tumor surgery

p53 plus chemotherapy

p53 gene therapy with concurrent chemotherapy

Group Type: EXPERIMENTAL

p53 with chemotherapy

Intervention Type: DRUG

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

p53 gene therapy alone

Intra-tumor injectio of rAd-p53 gene with no concurrent treatment

Group Type: EXPERIMENTAL

p53 gene therapy

Intervention Type: DRUG

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

Interventions

p53 gene with surgery

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

Intervention Type: DRUG

surgery

remove tumor surgery

Intervention Type: PROCEDURE

p53 with chemotherapy

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

Intervention Type: DRUG

p53 gene therapy

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

Intervention Type: DRUG

Other Intervention Names

no other names; no other names; no other names; no other names

Eligibility Criteria

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 -

• 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

Longjiang Li, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

qing yu, MD

Role: CONTACT

qingyu36@hotmail.com

86-755-33065218

Facility Contacts

Longjiang Li, PhD, MD

Role: primary

muzili63@163.com

86-28-85503389

Other Identifiers

rAd-p53-002

Identifier Type: -

Identifier Source: org_study_id