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

Primary Purpose

Malignant Pleural Effusion,, Malignant Ascites

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Drug-packaging microparticles

About this trial

This is an interventional treatment trial for Malignant Pleural Effusion, focused on measuring Pleural Effusion, ascites, Malignant

Eligibility Criteria

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

Inclusion Criteria:

Clinical diagnosis of malignant ascites or malignant pleural effusion

Exclusion Criteria:

Non-malignant ascites or pleural effusion

Sites / Locations

Hubei Provincial Traditional Chinese Medical Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug-packaging Microparticles

Arm Description

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

Outcomes

Primary Outcome Measures

Volume of Ascites or Pleural Effusion

Secondary Outcome Measures

Full Information

NCT ID

NCT01854866

First Posted

April 12, 2013

Last Updated

September 28, 2013

Sponsor

Huazhong University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT01854866

Brief Title

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

Official Title

Phase II Study of Tumor Cell-derived Microparticles Used as Vectors of Chemotherapeutic Drugs to Treat Malignant Ascites and Pleural Effusion

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Pleural Effusion,, Malignant Ascites

Keywords

Pleural Effusion, ascites, Malignant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug-packaging Microparticles

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Drug-packaging microparticles

Intervention Description

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

Primary Outcome Measure Information:

Title

Volume of Ascites or Pleural Effusion

Time Frame

10 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical diagnosis of malignant ascites or malignant pleural effusion Exclusion Criteria: Non-malignant ascites or pleural effusion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bo Huang, Ph.D

Organizational Affiliation

Huazhong University of Science and Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hubei Provincial Traditional Chinese Medical Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430070

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

23250412

Citation

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.

Results Reference

background

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/23250412

Description

Related information

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

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