rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors

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:
NCT00902083
First received: May 11, 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 , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.


Condition Intervention Phase
Advanced Oral and Maxillofacial Malignant Tumors
Drug: p53 gene with surgery
Procedure: surgery
Drug: p53 with chemotherapy
Drug: p53 gene therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 Mono-Therapy, With Concurrent Chemotherapy, or Combination With Surgery in Subjects With Advanced Oral and Maxillofacial Malignant Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • overall best response rate [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • progress free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: surgery plus p53 gene
using p53 gene therapy before surgery
Drug: p53 gene with surgery
pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
Other Name: no other names
Active Comparator: surgery alone
Surgery without pre-p53 gene therapy
Procedure: surgery
remove tumor surgery
Other Name: no other names
Experimental: p53 plus chemotherapy
p53 gene therapy with concurrent chemotherapy
Drug: p53 with chemotherapy
p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy
Other Name: no other names
Experimental: p53 gene therapy alone
Intra-tumor injectio of rAd-p53 gene with no concurrent treatment
Drug: p53 gene therapy
p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
Other Name: no other names

Detailed Description:

Primary objectives of this study is to determine the efficacy profiles of rAd-p53 intra-tumor injection alone, with concurrent chemotherapy, or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors(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,or surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Advanced stages of Oral and Maxillofacial 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 Oral and Maxillofacial 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: NCT00902083

Contacts
Contact: qing yu, MD 86-755-33065218 qingyu36@hotmail.com

Locations
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Longjiang Li, PhD, MD    86-28-85503389    muzili63@163.com   
Principal Investigator: Longjiang Li, PhD, MD         
Sponsors and Collaborators
Shenzhen SiBiono GeneTech Co.,Ltd
Investigators
Principal Investigator: Longjiang Li, PhD, MD West China Hospital
  More Information

No publications provided

Responsible Party: Shenzhen SiBiono GeneTech Co.,Ltd
ClinicalTrials.gov Identifier: NCT00902083     History of Changes
Other Study ID Numbers: rAd-p53-002
Study First Received: May 11, 2009
Last Updated: April 6, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Shenzhen SiBiono GeneTech Co.,Ltd:
p53 gene
Oral and Maxillofacial
gene therapy
malignant tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014