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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Shenzhen SiBiono GeneTech Co.,Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier:
NCT00894153
First received: May 4, 2009
Last updated: April 6, 2012
Last verified: February 2010
  Purpose

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 Intervention Phase
Neoplasms
Drug: chemotherapy plus p53
Drug: chemotherapy
Radiation: radiotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shenzhen SiBiono GeneTech Co.,Ltd:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: May 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT00894153     History of Changes
Other Study ID Numbers: rAd-p53-001
Study First Received: May 4, 2009
Last Updated: April 6, 2012
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms
Li-Fraumeni Syndrome
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 21, 2014