Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Drug: rAdp53; Drug: Cisplatin; Drug: rAdp53 plus cisplatin

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shuanyin Yang, MD; Phone Number: 86-18149098803; Email: yangshuanying66@163.com
• Study Contact Backup: Name: wei wang, MD; Phone Number: 86-13923853040; Email: wei.wang@163.com

Study Locations

• China
  • Shanxi
    • Xian, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiao Tong University
      • Contact: wei wang, MD; Phone Number: 86-13923853040; Email: wei.wang@163.com
      • Contact: shuanying yang, MD; Phone Number: 86-18149098803; Email: yangshuanying66@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen SiBiono GeneTech Co.,Ltd

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: April 24, 2015
• First Submitted That Met QC Criteria: April 24, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Estimate): April 29, 2015
• Last Update Submitted That Met QC Criteria: April 24, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: malignant pleural effusion, p53 gene therapy, cisplatin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: rAd-p53-H2015002