Trials Sponsors Conditions Drugs Pricing

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

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 systemDevice

One treatment of Total Body Hyperthermia

Exatherm-TBH system

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Jonathan Kiev
Otherlead
Exatherm, Inc
Industrycollaborator

Study Sites (1)

University of Kentucky, Markey Cancer Center

Lexington, Kentucky, 40536, United States

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

Jonathan Kiev, MD
Lucille P. Markey Cancer Center at University of Kentucky
PRINCIPAL INVESTIGATOR

Enrollment

4 participants (actual enrollment reported by the registry).

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 2015

Actual (reported)

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.
+4 more criteria

Perfusion-Induced Hyperthermia for Metastatic Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (4)

Study Arms (1)

Exatherm-TBH system

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (5)

Secondary Outcomes (4)

Study Arms (1)

Exatherm-TBH system

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations