p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage
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
1 other identifier
interventional
1,200
1 country
1
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 , with concurrent radiotherapy, or combination with surgery for treatment of head and neck malignant tumors in advanced stage .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2009
Longer than P75 for phase_4
1 active site
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
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 4, 2009
CompletedFirst Posted
Study publicly available on registry
May 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 9, 2012
February 1, 2010
3.1 years
May 4, 2009
April 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
3 years
Study Arms (3)
chemo plus p53
EXPERIMENTALchemotherapy plus p53
chemo only
ACTIVE COMPARATORchemotherapy group
radio
ACTIVE COMPARATORradiotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Advanced stages of head and neck 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 head and neck 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)
Department of oral and maxillofacial surgery, Huaxi university of medical science
Chendu, Shichuan, 610041, China
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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 4, 2009
First Posted
May 6, 2009
Study Start
May 1, 2009
Primary Completion
June 1, 2012
Study Completion
June 1, 2013
Last Updated
April 9, 2012
Record last verified: 2010-02