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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
4
One treatment of Total Body Hyperthermia
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States
Safety as measured by adverse events
Incidence of adverse events as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0. Adverse event data and corresponding toxicity grades during treatment will be summarized in the form of tables. Incidence tables will be generated to summarize incidence of patients reporting at least one episode of each specific adverse event, incidence of adverse events causing withdrawal and incidence of serious adverse event. The total number of episodes for each event reported (Frequency Table), the severity and attribution to study therapy of each episode reported (Severity Table and Attribution Table) will also be displayed. Safety data will be summarized for the overall treated group and the overall concurrent control group. Reversibility of the adverse events and toxicities will also be summarized.
Time frame: Up to 12 weeks after treatment
Exatherm-TBH device functionality
Device functionality will be documented and summarized using descriptive statistics and presented in the form of tables
Time frame: Time frame: day 1
Safety as measured by serious adverse events
Incidence of serious adverse events associated with hyperthermic treatment as graded by the NCI CTCAE v. 4.0. Summarized in the form of tables. Listings of adverse events by patients will include the time to onset, the duration of each event, the severity of each event, and the relationship of the event to study therapy, whether it was a serious event, and whether it caused withdrawal.
Time frame: Up to 12 weeks after treatment
Quality of Life
Assess changes in quality of life as documented by the EQ-DL-3L. QOL and neurocognitive testing will be summarized using descriptive statistics including mean, median and variation levels of QOL score
Time frame: Baseline and up to 1 year after treatment
Complication rates associated with hyperthermic treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Complication rates will be documented and summarized using descriptive statistics and presented in the form of tables
Time frame: Up to 12 weeks post-treatment
Response rate
Assess clinical benefit rate as documented by CR+PR+SD.
Time frame: Up to 12 weeks after treatment
Time to treatment failure
Documentation of disease progression presented with Kaplan Meier curve.
Time frame: Up to 12 weeks after treatment
Progression free survival
Progression free survival following hyperthermic therapy presented with Kaplan Meier curve
Time frame: Baseline up to 1 year
Death
Documentation of time of death presented with Kaplan Meier curve
Time frame: Baseline up to 1 year