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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| cisplatin | Active Comparator | cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rAdp53 | Drug | Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | the rate of complete response and partial response | from starting study treatment to 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuanyin Yang, MD | Contact | 86-18149098803 | yangshuanying66@163.com | |
| Wei Wang, MD | Contact | 86-13923853040 | wei.wang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xian | Shanxi | 710061 | China |
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| ID | Term |
|---|---|
| D016066 | Pleural Effusion, Malignant |
| ID | Term |
|---|---|
| D010997 | Pleural Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | Cisplatin will be administered by intra chest cavity infusion |
|
| rAdp53 plus cisplatin | Drug | Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion |
|
| adverse events | from starting study treatment to 30 days after the last treatment |
| D009369 |
| Neoplasms |
| D010996 | Pleural Effusion |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |