NCT02409108

Perfusion-Induced Hyperthermia for Metastatic Carcinoma

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Jonathan Kiev · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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 (42°C) 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 (43°C 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.

Conditions

• Metastatic Non-Small Cell Lung Carcinoma
• Solid Tumor, Adult

Interventions

Type	Name	Description
DEVICE	Exatherm-TBH system	One treatment of Total Body Hyperthermia

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-04-01
• Completion: 2019-02-16
• First posted: 2015-04-06
• Last updated: 2019-04-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study