Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Recombinant Adenoviral Human p53 Gene With or Without Cisplatin in Treatment of Malignant Pleural - a Phase 2, Double Blinded, Randomized, Active Controlled Study

Conditions
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Malignant Pleural Effusion

Intervention / Treatment
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* Drug: rAdp53
* Drug: Cisplatin
* Drug: rAdp53 plus cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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; renal insufficiency requiring hemodialysis or peritoneal dialysis; pregnant or lactating women; mental disorder or disease.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rAdp53<br>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 | Drug: rAdp53<br>* Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion<br>* Other names: recombinant adenoviral p53 human gene;|
| Active Comparator: cisplatin<br>cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21 | Drug: Cisplatin<br>* Cisplatin will be administered by intra chest cavity infusion<br>|
| Experimental: rAdp53 plus cisplatin<br>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 | Drug: rAdp53 plus cisplatin<br>* Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate | the rate of complete response and partial response | from starting study treatment to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effusion-free survival | effusion-free survival | from starting study treatment to 2 years | 
| Karnofsky Performance Status |  | from starting study treatment to 2 years | 
| adverse events |  | from starting study treatment to 30 days after the last treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant pleural effusion, p53 gene therapy, cisplatin