Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Phase 2

• Conditions: Malignant Pleural Effusion
• Interventions: Drug: rAdp53; Drug: Cisplatin; Drug: rAdp53 plus cisplatin

• Registration Number: NCT02429726
• Lead Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Brief 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.

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 Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-24
• Study First Submitted QC: 2015-04-24
• Last Update Submitted: 2015-04-24
• Study First Posted: 2015-04-29
• Last Update Posted: 2015-04-29
• Study Start: 2015-06
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. histopathologically diagnosed original cancer with malignant pleural effusion;
2. 18 years or older;
3. with normal tests of hemogram, blood coagulation, liver and kidney function; 6.signed the informed consent form.
4. signed the informed consent form

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Exclusion Criteria

1. Serious blood coagulation disorder, bleeding tendency, platelet < 6 * 1000000000/L;
2. have serious heart, lung function abnormalities or severe diabetes patients;
3. active infection;
4. severe atherosclerosis;
5. AIDS patients;
6. serious thrombotic or embolic events within 6 months;
7. renal insufficiency requiring hemodialysis or peritoneal dialysis;
8. pregnant or lactating women;
9. mental disorder or disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rAdp53	rAdp53	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	Cisplatin	cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
rAdp53 plus cisplatin	rAdp53 plus cisplatin	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

Primary Outcome Measures

Name	Time	Method
objective response rate	from starting study treatment to 3 months	the rate of complete response and partial response

Secondary Outcome Measures

Name	Time	Method
effusion-free survival	from starting study treatment to 2 years	effusion-free survival
adverse events	from starting study treatment to 30 days after the last treatment
Karnofsky Performance Status	from starting study treatment to 2 years

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiao Tong University; 🇨🇳 Xian, Shanxi, China