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

April 6, 2012 updated by: Shenzhen SiBiono GeneTech Co.,Ltd

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shichuan
      • Chendu, Shichuan, China, 610041
        • Recruiting
        • Department of oral and maxillofacial surgery, Huaxi university of medical science
        • Contact:
          • Longjiang Li, Ph.D., M.D
          • Phone Number: 028-85503389
        • Principal Investigator:
          • longjiang Li, M.D., Ph. D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: chemo plus p53
chemotherapy plus p53
Drug: chemotherapy plus p53
chemotherapy plus p53
ACTIVE_COMPARATOR: chemo only
chemotherapy group
Drug: chemotherapy
chemotherapy
ACTIVE_COMPARATOR: radio
radiotherapy
Radiation: radiotherapy
radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 5, 2009

First Posted (ESTIMATE)

May 6, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2012

Last Update Submitted That Met QC Criteria

April 6, 2012

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • rAd-p53-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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