Malignant Pleural EffusionPhase 2NCT02429726
Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion
A Phase 2 study testing rAdp53, Cisplatin and rAdp53 plus cisplatin in people with Malignant Pleural Effusion, run by Shenzhen SiBiono GeneTech Co.,Ltd at 1 site in China.
Trial summary
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Effusion
- What is being tested?
- rAdp53, Cisplatin and rAdp53 plus cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Jun 2017
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histopathologically diagnosed original cancer with malignant pleural effusion;
- 18 years or older;
- with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
- signed the informed consent form
Who cannot join
- Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- have serious heart, lung function abnormalities or severe diabetes patients;
- active infection;
- severe atherosclerosis;
- AIDS patients;
- serious thrombotic or embolic events within 6 months;
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- renal insufficiency requiring hemodialysis or peritoneal dialysis;
- pregnant or lactating women;
- mental disorder or disease.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiao Tong University
Xian, Shanxi, 710061
wei wang, MD, 86-13923853040, wei.wang@163.com
shuanying yang, MD, 86-18149098803, yangshuanying66@163.com
About this study
Official title: Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study.
Read the detailed description
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. Study design: phase 2, double blinded, randomized, active controlled.Ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rAd-p53, cisplatin, and rAd-p53 combined with cisplatin. The study endpoints are objective response rate, Karnofsky score, effusion-free survival, and safety.
- Conditions
- Malignant Pleural Effusion
- Being tested
- rAdp53, Cisplatin, rAdp53 plus cisplatin
- Keywords
- malignant pleural effusion, p53 gene therapy, cisplatin
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rAdp53Drug
Also called recombinant adenoviral p53 human gene
Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
CisplatinDrug
Cisplatin will be administered by intra chest cavity infusion
rAdp53 plus cisplatinDrug
Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion
| Study group | Role | What they receive |
|---|---|---|
| rAdp53 | Experimental | 2 x 10^12 viral particles of rAdp53 gene are given in 40 ml of saline by intra-cavity infusion at day of 7, 15 and 21 Receives: Drug: rAdp53 |
| cisplatin | Active comparator | cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21 Receives: Drug: Cisplatin |
| rAdp53 plus cisplatin | Experimental | 2 x 10^12 viral particles of rAdp53 gene and cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21 Receives: Drug: rAdp53 plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
the rate of complete response and partial response
Measured: from starting study treatment to 3 months
Secondary outcomes (3)
effusion-free survival
effusion-free survival
Measured: from starting study treatment to 2 years
Karnofsky Performance Status
Measured: from starting study treatment to 2 years
adverse events
Measured: from starting study treatment to 30 days after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural EffusionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429726
- Sponsor's protocol ID
- rAd-p53-H2015002
- Status last verified
- Apr 2015
- First submitted
- 24 Apr 2015
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study
- ClinicalTrials.gov ID
- NCT02429726
- Acronym / sponsor ID
- rAd-p53-H2015002
- Conditions
- Malignant Pleural Effusion
- Keywords
- malignant pleural effusion, p53 gene therapy, cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shenzhen SiBiono GeneTech Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Apr 2015 (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.
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. This is a phase 2, double blinded, randomized, active controlled study.
Detailed description
Objective of this study is to investigate of efficacy and safety of recombinant adenoviral human p53 Gene (rAd-p53) in treatment of malignant pleural effusion, compared to cisplatin. Study design: phase 2, double blinded, randomized, active controlled.Ninety patients with malignant pleural effusion, who meet the study inclusion criteria and none of exclusion criteria, will be randomized into 3 treatment groups: rAd-p53, cisplatin, and rAd-p53 combined with cisplatin. The study endpoints are objective response rate, Karnofsky score, effusion-free survival, and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rAdp53 | Experimental | Drug: rAdp532 x 10^12 viral particles of rAdp53 gene are given in 40 ml of saline by intra-cavity infusion at day of 7, 15 and 21 |
| cisplatin | Active comparator | Drug: Cisplatincisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21 |
| rAdp53 plus cisplatin | Experimental | Drug: rAdp53 plus cisplatin2 x 10^12 viral particles of rAdp53 gene and cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histopathologically diagnosed original cancer with malignant pleural effusion;
- 18 years or older;
- with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
- signed the informed consent form
Key exclusion criteria (9 listed)
- Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
- have serious heart, lung function abnormalities or severe diabetes patients;
- active infection;
- severe atherosclerosis;
- AIDS patients;
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 |
|---|---|---|
| rAdp53Also: recombinant adenoviral p53 human geneRecombinant adenoviral p53 human gene will be administered by intra chest cavity infusion | Drug | rAdp53 |
| CisplatinCisplatin will be administered by intra chest cavity infusion | Drug | cisplatin |
| rAdp53 plus cisplatinRecombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion | Drug | rAdp53 plus cisplatin |
Primary outcome
objective response rate
Time frame: from starting study treatment to 3 months
the rate of complete response and partial response
3 secondary outcomes
effusion-free survival
Time frame: from starting study treatment to 2 years
Karnofsky Performance Status
Time frame: from starting study treatment to 2 years
adverse events
Time frame: from starting study treatment to 30 days after the last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rAdp53, Cisplatin and rAdp53 plus cisplatin in people with Malignant Pleural Effusion, 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 4 inclusion and 9 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 29 Apr 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shuanyin Yang, MD (86-18149098803, yangshuanying66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: from starting study treatment to 3 months). 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 29 Apr 2015.