Advanced Oral and Maxillofacial Malignant TumorsPhase 4rAd-p53NCT00902083
rAd-p53 Gene Therapy for Advanced Oral and Maxillofacial Malignant Tumors
A Phase 4 study testing p53 gene with surgery, surgery and p53 with chemotherapy in people with Advanced Oral and Maxillofacial Malignant Tumors, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Advanced Oral and Maxillofacial Malignant Tumors
- What is being tested?
- p53 gene with surgery, surgery and p53 with chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Jul 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Longjiang Li, PhD, MD, 86-28-85503389, muzili63@163.com
Longjiang Li, PhD, MD
About this study
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
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.
Read the 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.
- Being tested
- p53 gene with surgery, surgery, p53 with chemotherapy, p53 gene therapy
- Keywords
- p53 gene, Oral and Maxillofacial, gene therapy, malignant tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
p53 gene with surgeryDrug
Also called no other names
pre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times
surgeryProcedure or surgery
Also called no other names
remove tumor surgery
p53 with chemotherapyDrug
Also called no other names
p53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy
p53 gene therapyDrug
Also called no other names
p53 gene treatment: 10exp12 virus particles per 3 days for 10 times
| Study group | Role | What they receive |
|---|---|---|
| surgery plus p53 gene | Experimental | using p53 gene therapy before surgery Receives: Drug: p53 gene with surgery |
| surgery alone | Active comparator | Surgery without pre-p53 gene therapy Receives: Procedure: surgery |
| p53 plus chemotherapy | Experimental | p53 gene therapy with concurrent chemotherapy Receives: Drug: p53 with chemotherapy |
| p53 gene therapy alone | Experimental | Intra-tumor injectio of rAd-p53 gene with no concurrent treatment Receives: Drug: p53 gene therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall best response rate
Measured: 3 years
Secondary outcomes (1)
progress free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Oral and Maxillofacial Malignant TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Longjiang Li, PhD, MD, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00902083
- Sponsor's protocol ID
- rAd-p53-002
- Acronym
- rAd-p53
- Status last verified
- Feb 2010
- First submitted
- 11 May 2009
- Last updated
- 9 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00902083
- Acronym / sponsor ID
- rAd-p53 / rAd-p53-002
- Keywords
- p53 gene, Oral and Maxillofacial, gene therapy, malignant tumors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 14 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| surgery plus p53 gene | Experimental | Drug: p53 gene with surgeryusing p53 gene therapy before surgery |
| surgery alone | Active comparator | Procedure: surgerySurgery without pre-p53 gene therapy |
| p53 plus chemotherapy | Experimental | Drug: p53 with chemotherapyp53 gene therapy with concurrent chemotherapy |
| p53 gene therapy alone | Experimental | Drug: p53 gene therapyIntra-tumor injectio of rAd-p53 gene with no concurrent treatment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| p53 gene with surgeryAlso: no other namespre-surgery p53 gene treatment: 10exp12 virus particles per 3 days for 5 times | Drug | surgery plus p53 gene |
| surgeryAlso: no other namesremove tumor surgery | Procedure or surgery | surgery alone |
| p53 with chemotherapyAlso: no other namesp53 gene treatment: 10exp12 virus particles per 3 days for 10 times Chemotherapy: standard chemotherapy | Drug | p53 plus chemotherapy |
| p53 gene therapyAlso: no other namesp53 gene treatment: 10exp12 virus particles per 3 days for 10 times | Drug | p53 gene therapy alone |
Primary outcome
overall best response rate
Time frame: 3 years
1 secondary outcome
progress free survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Longjiang Li, PhD, MD principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing p53 gene with surgery, surgery and p53 with chemotherapy in people with Advanced Oral and Maxillofacial Malignant Tumors, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qing yu, MD (86-755-33065218, qingyu36@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall best response rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2012.