Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Malignant Pleural Effusion Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02429726
• Other study ID #: rAd-p53-H2015002
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 24, 2015
• Last updated: April 24, 2015
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2015
• Source: Shenzhen SiBiono GeneTech Co.,Ltd
• Contact: Shuanyin Yang, MD
• Phone: 86-18149098803
• Email: yangshuanying66[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Effusion
• Pleural Effusion
• Pleural Effusion, Malignant

Intervention

Drug:
• rAdp53
Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
• Cisplatin
Cisplatin will be administered by intra chest cavity infusion
• rAdp53 plus cisplatin
Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiao Tong University	Xian	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen SiBiono GeneTech Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	the rate of complete response and partial response	from starting study treatment to 3 months	No
Secondary	effusion-free survival	effusion-free survival	from starting study treatment to 2 years	No
Secondary	Karnofsky Performance Status		from starting study treatment to 2 years	No
Secondary	adverse events		from starting study treatment to 30 days after the last treatment	Yes