Viewing Study NCT02409108



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Last Modification Date: 2024-10-26 @ 11:41 AM
Study NCT ID: NCT02409108
Status: COMPLETED
Last Update Posted: 2019-04-12
First Post: 2015-03-17

Brief Title: Perfusion-Induced Hyperthermia for Metastatic Carcinoma
Sponsor: Jonathan Kiev
Organization: University of Kentucky

Study Overview

Official Title: An Early Feasibility Study of Perfusion-Induced Hyperthermia for Metastatic Non-Small Cell Lung Carcinoma and All Relapsed Malignancies for Which Curative Therapy is Not Possible
Status: COMPLETED
Status Verified Date: 2019-04
Last Known Status: None
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: The purpose of this study is to gather information on how safe the hyperthermia treatment delivered via the Exatherm-TBH the device that will heat your blood and deliver it back to you added to the best supportive care is to patients who have advanced persistent or recurrent unresectable Cancer
Detailed Description: One potential candidate for a new approach to advanced cancer therapy is hyperthermia because cancer cells are thermo-sensitive with significantly reduced heat shock protein HSP expression Moreover hyperthermia 42C causes repression of genes involved in the cell cycle and cellular growth and proliferation Upon exposure to hyperthermic conditions HSP expression is increased in normal cells However when cancer cells are exposed to hyperthermia they initially express significantly less HSPs than normal cells which sensitizes them to hyperthermia Mild hyperthermia 43C for less than two hours induces extensive double-stranded DNA fragmentation and at a later time apoptosis in murine thymocytes In cells with irreparable levels of DNA damage apoptosis is the means of elimination

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: True
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2014-089 OTHER University of Kentucky None