NCT01854866

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 1, 2013

Status Verified

September 1, 2013

Enrollment Period

10 months

First QC Date

April 12, 2013

Last Update Submit

September 28, 2013

Conditions

Malignant Pleural Effusion,Malignant Ascites

Keywords

Pleural EffusionascitesMalignant

Outcome Measures

Primary Outcomes (1)

  • Volume of Ascites or Pleural Effusion

    10 months

Study Arms (1)

Drug-packaging Microparticles

EXPERIMENTAL

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

Other: Drug-packaging microparticles

Interventions

Drug-packaging microparticlesOTHER

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

Drug-packaging Microparticles

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of malignant ascites or malignant pleural effusion

You may not qualify if:

  • Non-malignant ascites or pleural effusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hubei Provincial Traditional Chinese Medical Hospital

Wuhan, Hubei, 430070, China

Location

Related Publications (1)

  • 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.

    PMID: 23250412BACKGROUND

Related Links

MeSH Terms

Conditions

Pleural Effusion, MalignantPleural EffusionAscites

Condition Hierarchy (Ancestors)

Pleural NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsPleural DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bo Huang, Ph.D

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 12, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

October 1, 2013

Record last verified: 2013-09

Locations

CN(1)