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

Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02429037
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
43
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: rAd-p53 plus radiation and chemotherapy

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

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.
Other Names:
  • p53 gene therapy

    • 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
    Other Names:
  • chemotherapy: cisplatin

    		•
    Active Comparator: radiation and chemotherapy

    radiation combined with chemotherapy

    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
    Other Names:
  • chemotherapy: cisplatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [three years after starting treatment]

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

    Secondary Outcome Measures

    1. Adverse events [from starting study treatment until 30 days after the last study treatment]

      Adverse events

    2. overall survival [three years after starting study treatment]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jiangsu cancer hospital Nanjing Jiangsu China 210000

    Sponsors and Collaborators

    • Shenzhen SiBiono GeneTech Co.,Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shenzhen SiBiono GeneTech Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT02429037
    Other Study ID Numbers:
    • rAd-p53-J1002
    First Posted:
    Apr 29, 2015
    Last Update Posted:
    Apr 29, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd
    p53
    gene therapy
    head and neck cancer
    Additional relevant MeSH terms:
    Head and Neck Neoplasms
    Cisplatin

    Study Results

    No Results Posted as of Apr 29, 2015