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Perfusion-Induced Hyperthermia for Metastatic Carcinoma | Clinical Trials | Clareo Health

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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

NCT02409108•Jonathan Kiev

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have histologically or cytologically confirmed diagnosis of Stage IIIB or Stage IV of non-small cell lung cancer and have received at least two lines of FDA-approved or National Comprehensive Cancer Network (NCCN) accepted systemic therapy and progressed through, or not tolerated, such therapy.
•* Subjects whose tumors harbor an exon 19 deletion or exon 21L858R EGFR mutation must have progressed on or had intolerance to EGFR tyrosine kinase inhibitor.
•* Subjects whose tumors harbor an AKL translocation must have progressed on or had intolerance to crizotinib (or any FDA approved ALK inhibitor).
•Eastern Cooperative Oncology Group (ECOG) performance status ≤2
•* Have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
•Must have undergone at least 2 prior regimens for treatment of recurrent or metastatic disease
•Life expectancy of greater than 3 months.
•Age ≥22 years.
•There is no restriction on the number of prior therapies allowed for this disease and prior radiation and chemotherapy is allowed, provided the subject has recovered from all grade 2 or greater toxicity prior to enrollment.
•Patient understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provide written informed consent prior to the procedure

Exclusion Criteria

•Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, or monoclonal antibodies such as bevacizumab, cetuximab or panitumumab) prior to entering the study or those who have not recovered to \< grade 2 adverse events due to agents administered more than 4 weeks earlier.
•Patients with stroke or TIA within 90 days prior to enrollment; or peripheral vascular disease requiring intervention within the 90 days prior to enrollment; or any known hemodynamically significant lesion or embolic plaque.
•Patients must have normal organ and marrow function as defined below:
•* leukocytes ≥3,000/mcL
•* absolute neutrophil count ≥1,500/mcL
•* total Bilirubin, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
•* glomerular filtration rate (GFR)\> 60 as defined by the Modification of Diet in Renal Disease (MDRD) formula
•* Thromboplastin Time (PTT) \< 35 sec)
•Patients with uncontrolled seizure disorder, spinal cord compression or carcinomatous meningitis.
•Patients with a mental disorder, psychiatric illness/social or concussion which would inhibit their ability to provide informed consent or prevent compliance with follow-up.
+9 more criteria

Locations (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Key Dates

Start Date

July 1, 2015

Primary Completion Date

April 1, 2018

Completion Date

February 16, 2019

Last Updated

April 12, 2019

Enrollment

ACTUAL participants

Conditions

Metastatic Non-Small Cell Lung CarcinomaSolid Tumor, Adult

Interventions

Exatherm-TBH system

DEVICE

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Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Perfusion-Induced Hyperthermia for Metastatic Carcinoma

Inclusion Criteria

Exclusion Criteria

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