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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00894153
Recruitment Status : Unknown
Verified February 2010 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : May 6, 2009
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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 .

Condition or disease Intervention/treatment Phase
Neoplasms Drug: chemotherapy plus p53 Drug: chemotherapy Radiation: radiotherapy Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00894153


Contacts
Contact: Longjiang Li, PhD 86-28-85503389 muzili63@163.com

Locations
China, Shichuan
Department of oral and maxillofacial surgery, Huaxi university of medical science Recruiting
Chendu, Shichuan, China, 610041
Contact: Longjiang Li, Ph.D. , M.D    028-85503389      
Principal Investigator: longjiang Li, M.D., Ph. D.         
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
More Information

Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT00894153     History of Changes
Other Study ID Numbers: rAd-p53-001
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: April 9, 2012
Last Verified: February 2010

Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53 gene
head and neck malignent tumors
gene therapy