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

The study is to investigate the anticancer effect and the related immunological mechanism of MTX-ATMPs in the treatment of malignant pleural effusion.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Biological: tumor derived microparticles; Drug: cisplatin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Feng Wu, Master; Phone Number: 086-13476080943; Email: wufengxiehe@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
      • Contact: Yang Jin, doctor; Phone Number: +86 13554361146; Email: whuhjy@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MTX-ATMPs; methotrexate-autologous tumor derived microparticles	Biological: tumor derived microparticles; The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
SHAM_COMPARATOR: cisplatin; Cisplatin is a traditional treatment for lung cancer	Drug: cisplatin; cisplatin is a traditional drug for lung cancer; Other Names: cisplatinum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pleural effusions volume	four weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Principal Investigator: Yang Jin, doctor, Union Hospital, Tongji Medical College, Huazhong University of Science & Technology

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (ESTIMATE): January 15, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 24, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: chemotherapy; malignant pleural effusion; microparticle
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: v1.4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share IPD now