Recombinant Adenoviral Human p53 Gene in Treatment of Malignant Pleural Effusion

SiBiono

Status and phase: Unknown; Phase 2

Conditions: Malignant Pleural Effusion

Treatments: Drug: Cisplatin; Drug: rAdp53; Drug: rAdp53 plus cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02429726

rAd-p53-H2015002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

rAdp53

Experimental group

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

Treatment:

Drug: rAdp53

cisplatin

Active Comparator group

Description:

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

Treatment:

Drug: Cisplatin

rAdp53 plus cisplatin

Experimental group

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

Treatment:

Drug: rAdp53 plus cisplatin