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Metastatic Non-Small Cell Lung CarcinomaNCT02409108

Perfusion-Induced Hyperthermia for Metastatic Carcinoma

A study testing Exatherm-TBH system in people with Metastatic Non-Small Cell Lung Carcinoma and Solid Tumor, Adult, run by Jonathan Kiev at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Exatherm-TBH system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
Jul 2015to 16 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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.
  • Pregnant women are excluded from this study
  • Patients with documented contraindication to anticoagulation therapy such as heparin induced thrombocytopenia or a documented coagulopathy or hematologic disorder that would contraindicated undergoing treatment and use of the associated anticoagulant agents required during treatment.
  • Patients with documented active bacterial, viral or fungal infection, untreated systematic peptic ulcer disease, uncontrolled diabetes mellitus or serious concurrent medical disease that could limit survival to less than 3 months.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for harm when exposed to hyperthermia, as well as negative interactions of these medications with hyperthermia.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kentucky, Markey Cancer Center

    Lexington, Kentucky, 40536

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Exatherm-TBH system
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exatherm-TBH systemDevice

    One treatment of Total Body Hyperthermia

Study groups in NCT02409108
Study groupRoleWhat they receive
Exatherm-TBH systemExperimentalOne treatment of Total Body Hyperthermia
Receives: Device: Exatherm-TBH system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 12 weeks after treatment

  2. Exatherm-TBH device functionality

    Device functionality will be documented and summarized using descriptive statistics and presented in the form of tables

    Measured: Time frame: day 1

  3. 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.

    Measured: Up to 12 weeks after treatment

  4. 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

    Measured: Baseline and up to 1 year after treatment

  5. Complication rates associated with hyperthermic treatment

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

    Measured: Up to 12 weeks post-treatment

Secondary outcomes (4)

  1. Response rate

    Assess clinical benefit rate as documented by CR+PR+SD.

    Measured: Up to 12 weeks after treatment

  2. Time to treatment failure

    Documentation of disease progression presented with Kaplan Meier curve.

    Measured: Up to 12 weeks after treatment

  3. Progression free survival

    Progression free survival following hyperthermic therapy presented with Kaplan Meier curve

    Measured: Baseline up to 1 year

  4. Death

    Documentation of time of death presented with Kaplan Meier curve

    Measured: Baseline up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionApr 2018
  4. Study completion16 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02409108
Sponsor's protocol ID
MCC-14-0929-F3R
Other IDs
2014-089
Status last verified
Apr 2019
First submitted
17 Mar 2015
Last updated
12 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exatherm-TBH system in people with Metastatic Non-Small Cell Lung Carcinoma and Solid Tumor, Adult, run by Jonathan Kiev at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety as measured by adverse events (time frame: Up to 12 weeks after treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02409108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.

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