NCT00902083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 9, 2012

Status Verified

February 1, 2010

Enrollment Period

3.1 years

First QC Date

May 11, 2009

Last Update Submit

April 6, 2012

Conditions

Advanced Oral and Maxillofacial Malignant Tumors

Keywords

p53 geneOral and Maxillofacialgene therapymalignant tumors

Outcome Measures

Primary Outcomes (1)

  • overall best response rate

    3 years

Secondary Outcomes (1)

  • progress free survival

    3 years

Study Arms (4)

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

p53 gene with surgeryDRUG

pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times

Also known as: no other names
surgery plus p53 gene
surgeryPROCEDURE

remove tumor surgery

Also known as: no other names
surgery alone
p53 with chemotherapyDRUG

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy

Also known as: no other names
p53 plus chemotherapy
p53 gene therapyDRUG

p53 gene treatment: 10exp12 virus particles per 3 days for 10 times

Also known as: no other names
p53 gene therapy alone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Genes, p53Surgical Procedures, OperativeDrug Therapy

Intervention Hierarchy (Ancestors)

Genes, Tumor SuppressorGenes, NeoplasmGenesGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGenes, RecessiveTherapeutics

Study Officials

  • Longjiang Li, PhD, MD

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

qing yu, MD

CONTACT

86-755-33065218qingyu36@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 14, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 9, 2012

Record last verified: 2010-02

Locations

CN(1)