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

Advanced Oral and Maxillofacial Malignant Tumors Clinical Trial

— rAd-p53  

Official title:

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00902083
• Other study ID #: rAd-p53-002
• Status: Recruiting
• Phase: Phase 4
• First received: May 11, 2009
• Last updated: April 6, 2012
• Start date: June 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2010
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: qing yu, MD
• Phone: 86-755-33065218
• Email: qingyu36[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Oral and Maxillofacial Malignant Tumors
• Neoplasms

Intervention

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

Procedure:
• surgery
remove tumor surgery

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

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall best response rate		3 years	Yes
Secondary	progress free survival		3 years	No