Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedApril 29, 2015
April 1, 2015
2 years
April 24, 2015
April 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
objective response rate
the rate of complete response and partial response
from starting study treatment to 3 months
Secondary Outcomes (3)
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
Study Arms (3)
rAdp53
EXPERIMENTAL2 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 COMPARATORcisplatin 40 mg in 40 ml of saline are given by intra-cavity infusion at day of 7, 15 and 21
rAdp53 plus cisplatin
EXPERIMENTAL2 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
Interventions
Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion
Eligibility Criteria
You may qualify if:
- histopathologically diagnosed original cancer with malignant pleural effusion;
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xi'an Jiao Tong University
Xian, Shanxi, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2015
First Posted
April 29, 2015
Study Start
June 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
April 29, 2015
Record last verified: 2015-04