Clinical trial NCT02657460: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Malignant Pleural Effusion
Keywords: chemotherapy
microparticle
malignant pleural effusion
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pleural effusions volume
timeFrame: four weeks
Secondary outcomes:
measure: Rivalta Test of pleural effusions
timeFrame: four weeks
measure: total protein level of pleural effusions
timeFrame: four weeks
measure: total karyocytes count of pleural effusions
timeFrame: four weeks
measure: lactic dehydrogenase level of pleural effusions
timeFrame: four weeks
measure: adenosine deaminase level of pleural effusions
timeFrame: four weeks
measure: the cytology test of pleural effusions
timeFrame: four weeks
measure: Karnofsky index
timeFrame: four weeks
measure: survival time
timeFrame: six month
measure: carcino embryonie antigen level in microgramme/L in serum
timeFrame: four weeks
measure: CYFRA21-1 level in ng/mL in serum
timeFrame: four weeks
measure: neuron specific annuals level in microgramme/L in serum
timeFrame: four weeks
measure: squamous cell carcinoma antigen level in ng/mL in serum
timeFrame: four weeks
measure: carcino embryonie antigen level in microgramme/L in pleural effusions
timeFrame: four weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
Study officials:
affiliation: Union Hospital, Tongji Medical College, Huazhong University of Science & Technology
name: Yang Jin, doctor
role: PRINCIPAL_INVESTIGATOR
References: