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Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Primary Purpose

Malignant Pleural Effusion

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
rAdp53
Cisplatin
rAdp53 plus cisplatin
Sponsored by
Shenzhen SiBiono GeneTech Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring malignant pleural effusion, p53 gene therapy, cisplatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Xi'an Jiao Tong University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

rAdp53

cisplatin

rAdp53 plus cisplatin

Arm Description

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 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21

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

Outcomes

Primary Outcome Measures

objective response rate
the rate of complete response and partial response

Secondary Outcome Measures

effusion-free survival
effusion-free survival
Karnofsky Performance Status
adverse events

Full Information

First Posted
April 24, 2015
Last Updated
April 24, 2015
Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02429726
Brief Title
Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen SiBiono GeneTech Co.,Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
Keywords
malignant pleural effusion, p53 gene therapy, cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rAdp53
Arm Type
Experimental
Arm Description
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
Arm Title
cisplatin
Arm Type
Active Comparator
Arm Description
cisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
Arm Title
rAdp53 plus cisplatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
rAdp53
Other Intervention Name(s)
recombinant adenoviral p53 human gene
Intervention Description
Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin will be administered by intra chest cavity infusion
Intervention Type
Drug
Intervention Name(s)
rAdp53 plus cisplatin
Intervention Description
Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion
Primary Outcome Measure Information:
Title
objective response rate
Description
the rate of complete response and partial response
Time Frame
from starting study treatment to 3 months
Secondary Outcome Measure Information:
Title
effusion-free survival
Description
effusion-free survival
Time Frame
from starting study treatment to 2 years
Title
Karnofsky Performance Status
Time Frame
from starting study treatment to 2 years
Title
adverse events
Time Frame
from starting study treatment to 30 days after the last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuanyin Yang, MD
Phone
86-18149098803
Email
yangshuanying66@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Wang, MD
Phone
86-13923853040
Email
wei.wang@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Xi'an Jiao Tong University
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei wang, MD
Phone
86-13923853040
Email
wei.wang@163.com
First Name & Middle Initial & Last Name & Degree
shuanying yang, MD
Phone
86-18149098803
Email
yangshuanying66@163.com

12. IPD Sharing Statement

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Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

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