Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion

NCT ID: NCT01854866

Last Updated: 2013-10-01

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

Brief Summary

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Malignant ascites and pleural effusion are common symptoms in patients with advanced cancer. Currently, the management of malignant ascites and pleural effusion is a considerable clinical challenge. The investigator hypothesized that tumor cell-derived microparticles packaging chemotherapeutic drugs might be a useful means to treat malignant ascites and pleural effusion. Thirty malignant ascites or pleural effusion patients will be recruited for Phase II clinical trials.

Detailed Description

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Ascites or pleural effusion were first removed from patients. The patients were then locally injected with microparticles packaging chemotherapeutic drugs 4 times a week. The therapeutic effects and side effects were recorded.

Conditions

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Malignant Pleural Effusion, Malignant Ascites

Keywords

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Pleural Effusion ascites Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug-packaging Microparticles

Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.

Group Type EXPERIMENTAL

Drug-packaging microparticles

Intervention Type OTHER

Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.

Interventions

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Drug-packaging microparticles

Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion Criteria

* Non-malignant ascites or pleural effusion
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Bo Huang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Huang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Huazhong University of Science and Technology

Locations

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Hubei Provincial Traditional Chinese Medical Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

References

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Tang K, Zhang Y, Zhang H, Xu P, Liu J, Ma J, Lv M, Li D, Katirai F, Shen GX, Zhang G, Feng ZH, Ye D, Huang B. Delivery of chemotherapeutic drugs in tumour cell-derived microparticles. Nat Commun. 2012;3:1282. doi: 10.1038/ncomms2282.

Reference Type BACKGROUND
PMID: 23250412 (View on PubMed)

Related Links

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Other Identifiers

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Soundny Biotech

Identifier Type: -

Identifier Source: org_study_id