search
Back to results

Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

Primary Purpose

Malignant Pleural Effusion

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
tumor derived microparticles
cisplatin
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion focused on measuring chemotherapy, microparticle, malignant pleural effusion

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology;
  2. The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes;
  3. stable vital sign with KPS(Karnofsky Performance Status) index more than 60;
  4. 18-70 years old;
  5. normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG;
  6. agreed to participate in the study and sign an informed consent;
  7. without other severe comorbidities.

Exclusion Criteria:

  1. lactating or pregnant patients;
  2. allergy to multiple drugs;
  3. with other severe comorbidities or psychological diseases;
  4. severe infection;
  5. participation in other clinical trials within the recent three months.

Sites / Locations

  • Union Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

MTX-ATMPs

cisplatin

Arm Description

methotrexate-autologous tumor derived microparticles

Cisplatin is a traditional treatment for lung cancer

Outcomes

Primary Outcome Measures

Pleural effusions volume

Secondary Outcome Measures

Rivalta Test of pleural effusions
total protein level of pleural effusions
total karyocytes count of pleural effusions
lactic dehydrogenase level of pleural effusions
adenosine deaminase level of pleural effusions
the cytology test of pleural effusions
Karnofsky index
survival time
carcino embryonie antigen level in microgramme/L in serum
CYFRA21-1 level in ng/mL in serum
neuron specific annuals level in microgramme/L in serum
squamous cell carcinoma antigen level in ng/mL in serum
carcino embryonie antigen level in microgramme/L in pleural effusions

Full Information

First Posted
January 11, 2016
Last Updated
February 24, 2019
Sponsor
Wuhan Union Hospital, China
search

1. Study Identification

Unique Protocol Identification Number
NCT02657460
Brief Title
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
Official Title
Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.
Detailed Description
Malignant pleural effusion(MPE) as a common complication of advanced lung cancer is lack of efficient treatments. The investigators have successfully produced tumor cell-derived microparticles packaging chemotherapy drugs and confirmed that this new integrative targeted biochemotherapy treatment could effectively restrain tumor growth at cellular and animal levels.This new method could control tumor growth in vivo effectively and induced pleural adhesion in the early clinical study. So the investigators attempt to explore the anticancer effect and related immune regulation mechanism of methotrexate-autologous tumor derived microparticles (MTX-ATMPs) in MPE treatment. The tumor cells in the malignant pleural effusion are prepared by screening, then MTX-ATMPs are made. Participants enrolled are randomly assigned to experimental and control group, each of them is injected with the prepared drug once in two days until the malignant pleural effusion are disappeared or the treatment cycle has been six times. During or after the whole treatment, reactions to each treatment of the participants are carefully followed up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Effusion
Keywords
chemotherapy, microparticle, malignant pleural effusion

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
MTX-ATMPs
Arm Type
Experimental
Arm Description
methotrexate-autologous tumor derived microparticles
Arm Title
cisplatin
Arm Type
Sham Comparator
Arm Description
Cisplatin is a traditional treatment for lung cancer
Intervention Type
Biological
Intervention Name(s)
tumor derived microparticles
Intervention Description
The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
cisplatinum
Intervention Description
cisplatin is a traditional drug for lung cancer
Primary Outcome Measure Information:
Title
Pleural effusions volume
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Rivalta Test of pleural effusions
Time Frame
four weeks
Title
total protein level of pleural effusions
Time Frame
four weeks
Title
total karyocytes count of pleural effusions
Time Frame
four weeks
Title
lactic dehydrogenase level of pleural effusions
Time Frame
four weeks
Title
adenosine deaminase level of pleural effusions
Time Frame
four weeks
Title
the cytology test of pleural effusions
Time Frame
four weeks
Title
Karnofsky index
Time Frame
four weeks
Title
survival time
Time Frame
six month
Title
carcino embryonie antigen level in microgramme/L in serum
Time Frame
four weeks
Title
CYFRA21-1 level in ng/mL in serum
Time Frame
four weeks
Title
neuron specific annuals level in microgramme/L in serum
Time Frame
four weeks
Title
squamous cell carcinoma antigen level in ng/mL in serum
Time Frame
four weeks
Title
carcino embryonie antigen level in microgramme/L in pleural effusions
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The diagnosis of lung cancer and malignant pleural effusion was confirmed by pathology and / or pleural fluid cytology; The routine surgery or systemic radio/chemotherapy was ineffective, the MPE relapsed, or routine treatment therapy was given up by self-causes; stable vital sign with KPS(Karnofsky Performance Status) index more than 60; 18-70 years old; normal haematopoietic function of bone marrow, no hemorrhagic tendency, blood routine test: HGB>=100g/L, WBC>4.0*10^9/L, PLT>80*10^9/L, serum ALT, AST within 2 times upper limit of normal, BUN within 1.5 time upper limit of normal, creatinine within normal range, normal EKG; agreed to participate in the study and sign an informed consent; without other severe comorbidities. Exclusion Criteria: lactating or pregnant patients; allergy to multiple drugs; with other severe comorbidities or psychological diseases; severe infection; participation in other clinical trials within the recent three months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Wu, Master
Phone
086-13476080943
Email
wufengxiehe@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Jin, doctor
Organizational Affiliation
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Jin, doctor
Phone
+86 13554361146
Email
whuhjy@sina.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share IPD now

Learn more about this trial

Clinical Trial of Tumor Cell-derived Microparticles Packaging Chemotherapeutic Drugs to Treat Malignant Pleural Effusion

We'll reach out to this number within 24 hrs