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

History of Changes

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:

Genetics Home Reference related topics: Li-Fraumeni syndrome

MedlinePlus related topics: Cancer

U.S. FDA Resources

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:

Advanced stages of Oral and Maxillofacial malignant tumors (stage III and VI)
At least one target tumor can be injected with study drug, the largest diameter greater than 2 cm
Histologically confirmed Oral and Maxillofacial malignant tumors
No prior chemotherapy, radiotherapy or biological tumor therapy in 2 weeks
Age: 18-85 years old
Expected to survive more 12 weeks
ECOG:0-2
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
Subject provided signed informed consent

Exclusion Criteria:

Hypersensitive to study drug
Tumor(s) locate very close to important blood vessels and nerves, which affect injection
With a coagulation and bleeding disorder
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
Local infection close to injection site or systemic infection
Pregnant or lactating
Principle investigator consider not suitable -

Contacts and Locations

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
Li-Fraumeni Syndrome
Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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