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

NCT ID: NCT00894153

Last Updated: 2012-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2013-06-30

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 , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .

Detailed 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.

Conditions

Neoplasms

Study Design

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

Study Groups

chemo plus p53

chemotherapy plus p53

Group Type: EXPERIMENTAL

chemotherapy plus p53

Intervention Type: DRUG

chemotherapy plus p53

chemo only

chemotherapy group

Group Type: ACTIVE_COMPARATOR

chemotherapy

Intervention Type: DRUG

chemotherapy

radio

radiotherapy

Group Type: ACTIVE_COMPARATOR

radiotherapy

Intervention Type: RADIATION

radiotherapy

Interventions

chemotherapy plus p53

chemotherapy plus p53

Intervention Type: DRUG

chemotherapy

chemotherapy

Intervention Type: DRUG

radiotherapy

radiotherapy

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenzhen SiBiono GeneTech Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of oral and maxillofacial surgery, Huaxi university of medical science

Chendu, Shichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Longjiang Li, PhD

Role: CONTACT

muzili63@163.com

86-28-85503389

Facility Contacts

Longjiang Li, Ph.D., M.D

Role: primary

028-85503389

Other Identifiers

rAd-p53-001

Identifier Type: -

Identifier Source: org_study_id