p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage

Neoplasms Clinical Trial

Official title:

Open-Label, Multi-Center, Randomized, Active-Controlled, Phase 4 Study of rAd-p53 Gene Therapy Combined With Chemotherapy and Radiotherapy in Treament of Head and Neck Cancer in Advanced Stage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00894153
• Other study ID #: rAd-p53-001
• Status: Recruiting
• Phase: Phase 4
• First received: May 4, 2009
• Last updated: April 6, 2012
• Start date: May 2009
• Est. completion date: June 2013

Study information

• Verified date: February 2010
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Longjiang Li, PhD
• Phone: 86-28-85503389
• Email: muzili63[@]163.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 , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .

Description:

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage (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, radiotherapy or surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Advanced stages of head and neck 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 head and neck 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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• chemotherapy plus p53
chemotherapy plus p53
• chemotherapy
chemotherapy

Radiation:
• radiotherapy
radiotherapy

Locations

Country	Name	City	State
China	Department of oral and maxillofacial surgery, Huaxi university of medical science	Chendu	Shichuan

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	Efficacy		3 years	Yes