rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial... | NCT00902083

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

NCT00902083

Sponsor

Shenzhen SiBiono GeneTech Co.,Ltd

Status

Unknown status

Last Update Posted

Apr 9, 2012Estimated

Enrollment

600Estimated

Phase

Phase 4

Conditions

Advanced Oral and Maxillofacial Malignant Tumors

Interventions

p53 gene with surgery
surgery
p53 with chemotherapy
p53 gene therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 13, 2009

First Posted Date

May 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2012

Last Update Posted Date

Apr 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 , or combination with surgery for treatment of advanced oral and maxillofacial malignant tumors.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgery plus p53 gene	Experimental	using p53 gene therapy before surgery	Drug: p53 gene with surgery
surgery alone	Active Comparator	Surgery without pre-p53 gene therapy	Procedure: surgery
p53 plus chemotherapy	Experimental	p53 gene therapy with concurrent chemotherapy	Drug: p53 with chemotherapy
p53 gene therapy alone	Experimental	Intra-tumor injectio of rAd-p53 gene with no concurrent treatment	Drug: p53 gene therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
p53 gene with surgery	Drug	pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times	surgery plus p53 gene

Measure	Description	Time Frame
overall best response rate		3 years

Measure	Description	Time Frame
progress free survival		3 years

Eligibility Module

Eligibility 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 -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
qing yu, MD	Contact	86-755-33065218		qingyu36@hotmail.com

Overall Officials

Name	Affiliation	Role
Longjiang Li, PhD, MD	West China Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital, Sichuan University	Recruiting	Chengdu	Sichuan	610041	China

ID	Term
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D016158	Genes, p53
D013514	Surgical Procedures, Operative
D004358	Drug Therapy

Ancestor Terms

ID	Term
D016147	Genes, Tumor Suppressor
D052138	Genes, Neoplasm
D005796	Genes
D040481	Genome Components

Browse Leaves

Not provided

Browse Branches

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