Perfusion-Induced Hyperthermia for Metastatic Carcinoma

NCT02409108 | Completed DMC FDA Device

• 2 other identifiers: MCC-14-0929-F3R2014-089
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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: 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.

  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

  Baseline and up to 1 year after treatment

• Complication rates associated with hyperthermic treatment

  Complication rates will be documented and summarized using descriptive statistics and presented in the form of tables

  Up to 12 weeks post-treatment

Secondary Outcomes (4)

• Response rate

  Up to 12 weeks after treatment

• Time to treatment failure

  Up to 12 weeks after treatment

• Progression free survival

  Baseline up to 1 year

• Death

  Baseline up to 1 year

Study Arms (1)

Exatherm-TBH system

EXPERIMENTAL

One treatment of Total Body Hyperthermia

Device: Exatherm-TBH system

Interventions

Exatherm-TBH system DEVICE

One treatment of Total Body Hyperthermia

Exatherm-TBH system

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Patients with high risk of cardiovascular event such as severe uncontrolled hypertension (\>170/110 systemic blood pressure on therapy), or pulmonary hypertension (greater than .5 systolic blood pressure
• ST elevation myocardial infarction within 30 days prior to enrollment; unstable angina or significant, untreated arrhythmias within 30 days prior to enrollment.
• Patients with moderate to severe heart failure, New York Heart Association (NYHA) class III or IV, liver dysfunction with total bilirubin \>2. 5 upper limit of normal, or serum creatinine \>2.5 mg/dL or any form of dialysis; within 30 days prior to enrollment.
• Patients with a major surgical procedure or other investigational agents within 30 days before study enrollment.
• Patients with known, untreated or progressive brain metastases will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

Sponsors & Collaborators

• Jonathan Kiev: lead
• Exatherm, Inc: collaborator

Study Sites (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jonathan Kiev, MD

  Lucille P. Markey Cancer Center at University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2015
• First Posted: April 6, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: February 16, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)