Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

NCT02429037

Advanced Head and Neck Cancer

UNKNOWN PHASE2

Surgery Combined With rAd-p53 Gene in Treatment Advanced Non-small-cell Carcinoma

NCT01574729

Non-small Cell Lung Cancer

UNKNOWN PHASE2

Oncolytic Adenovirus(H101) Combined With PD-1 Inhibitors in Patients With Advanced Malignant Pleural Mesothelioma

NCT06031636

Malignant Pleural Mesothelioma, Advanced

RECRUITING

p53 Gene Therapy for Head and Neck Malignant Tumors in Advanced Stage

NCT00894153

Neoplasms

UNKNOWN PHASE4

A Phase Ⅲ Clinical Study of Combined Cisplatin Versus Placebo Combined With Intracavitary Cisplatin Injection in the Treatment of Malignant Pleural Effusions

NCT04914598

Malignant Pleural Effusion

ACTIVE_NOT_RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malignant Pleural Effusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

rAdp53

Intervention Type DRUG

Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion

cisplatin

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

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

Cisplatin will be administered by intra chest cavity infusion

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

Group Type EXPERIMENTAL

rAdp53 plus cisplatin

Intervention Type DRUG

Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

rAdp53

Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion

Intervention Type DRUG

Cisplatin

Cisplatin will be administered by intra chest cavity infusion

Intervention Type DRUG

rAdp53 plus cisplatin

Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

recombinant adenoviral p53 human gene

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No