Viewing Study NCT01854866


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Study NCT ID: NCT01854866
Status: UNKNOWN
Last Update Posted: 2013-10-01
First Post: 2013-04-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Safety and Effectiveness Study of Tumor Cell-derived Microparticles to Treat Malignant Ascites and Pleural Effusion
Sponsor: Huazhong University of Science and Technology
Organization:

Study Overview

Official Title: Phase II Study of Tumor Cell-derived Microparticles Used as Vectors of Chemotherapeutic Drugs to Treat Malignant Ascites and Pleural Effusion
Status: UNKNOWN
Status Verified Date: 2013-09
Last Known Status: ENROLLING_BY_INVITATION
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: