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

Primary Purpose

Advanced Head and Neck Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rAd-p53
radiation
Cisplatin
Sponsored by
Shenzhen SiBiono GeneTech Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Head and Neck Cancer focused on measuring p53, gene therapy, head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jiangsu cancer hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

rAd-p53 plus radiation and chemotherapy

radiation and chemotherapy

Arm Description

rAd-p53 tumor injection combined with radio- and chemo-therapy.

radiation combined with chemotherapy

Outcomes

Primary Outcome Measures

progression-free survival
Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.

Secondary Outcome Measures

Adverse events
Adverse events
overall survival
Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.

Full Information

First Posted
April 20, 2015
Last Updated
April 23, 2015
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02429037
Brief Title
P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Head and Neck Cancer
Keywords
p53, gene therapy, head and neck cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rAd-p53 plus radiation and chemotherapy
Arm Type
Experimental
Arm Description
rAd-p53 tumor injection combined with radio- and chemo-therapy.
Arm Title
radiation and chemotherapy
Arm Type
Active Comparator
Arm Description
radiation combined with chemotherapy
Intervention Type
Drug
Intervention Name(s)
rAd-p53
Other Intervention Name(s)
p53 gene therapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
radiation
Intervention Description
radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
chemotherapy: cisplatin
Intervention Description
Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15
Primary Outcome Measure Information:
Title
progression-free survival
Description
Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.
Time Frame
three years after starting treatment
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events
Time Frame
from starting study treatment until 30 days after the last study treatment
Title
overall survival
Description
Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.
Time Frame
three years after starting study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histopathologically diagnosed head and neck cancer; unresectable, locally advanced; 18 years or older; with an Eastern Cooperative Oncology Group (ECOG) score of 0-2; with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form. Exclusion Criteria: Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L; have serious heart, lung function abnormalities or severe diabetes patients; active infection; severe atherosclerosis; AIDS patients; serious thrombotic or embolic events within 6 months; renal insufficiency requiring hemodialysis or peritoneal dialysis; pregnant or lactating women; mental disorder or disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xia He, MD, PhD
Phone
86-13601458518
Email
13601458515@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Wu, MD, PhD
Phone
86-13923853040
Email
595864485@qq.com
Facility Information:
Facility Name
Jiangsu cancer hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia He, MD, PhD
Phone
86-13601458518
Email
13601458515@qq.com
First Name & Middle Initial & Last Name & Degree
Jianfeng Wu, MD, PhD
Phone
86-13923753040
Email
595864485@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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