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

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

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 -