P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

Advanced Head and Neck Cancer Clinical Trial

Official title:

Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02429037
• Other study ID #: rAd-p53-J1002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 20, 2015
• Last updated: April 23, 2015
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2015
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Xia He, MD, PhD
• Phone: 86-13601458518
• Email: 13601458515[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

Description:

To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. histopathologically diagnosed head and neck cancer;

2. unresectable, locally advanced;

3. 18 years or older;

4. with an Eastern Cooperative Oncology Group (ECOG) score of 0-2;

5. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.

Exclusion Criteria:

1. Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;

2. have serious heart, lung function abnormalities or severe diabetes patients;

3. active infection;

4. severe atherosclerosis;

5. AIDS patients;

6. serious thrombotic or embolic events within 6 months;

7. renal insufficiency requiring hemodialysis or peritoneal dialysis;

8. pregnant or lactating women;

9. mental disorder or disease.

Study Design

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

Related Conditions & MeSH terms

• Advanced Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• rAd-p53
multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle.

Radiation:
• radiation
radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

Drug:
• Cisplatin
Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15

Locations

Country	Name	City	State
China	Jiangsu cancer hospital	Nanjing	Jiangsu

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	progression-free survival	Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.	three years after starting treatment	No
Secondary	Adverse events	Adverse events	from starting study treatment until 30 days after the last study treatment	Yes
Secondary	overall survival	Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.	three years after starting study treatment	No