Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
NCT ID: NCT01896778
Last Updated: 2022-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
9 participants
INTERVENTIONAL
2013-10-04
2018-02-23
Brief Summary
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Detailed Description
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I. To determine the feasibility and efficacy of 2 different Body Warming to Alter (Thermo) Regulation and the Microenvironment (B-WARM) regimens on altering tumor blood flow in patients with a variety of malignancies.
SECONDARY OBJECTIVES:
I. To determine if duration and thermal dose of B-WARM changes duration and extent of tumor blood flow changes in patients with a variety of malignancies.
OUTLINE: Patients are randomized to 1of 2 arms.
ARM I: Patients undergo B-WARM at 39 degrees Celsius (C) for 30 minutes.
ARM II: Patients undergo B-WARM at 39 degrees C for 2 hours.
After completion of study, patients are followed up at 30 days.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Arm I (B-WARM for 30 minutes)
Patients undergo B-WARM at 39 degrees C for 30 minutes.
Hyperthermia Treatment
Undergo B-WARM
Laboratory Biomarker Analysis
Correlative studies
Arm II (B-WARM for 2 hours)
Patients undergo B-WARM at 39 degrees C for 2 hours.
Hyperthermia Treatment
Undergo B-WARM
Laboratory Biomarker Analysis
Correlative studies
Interventions
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Hyperthermia Treatment
Undergo B-WARM
Laboratory Biomarker Analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have measurable disease (1.0 cm or greater) by computed tomography (CT) scan
* Have an estimated glomerular filtration rate (eGFR) (using the Cockcroft-Gault equation) of more than 60 mL/min
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment
* Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
* History of any condition deemed by the principal investigator to be a contraindication to B-WARM therapy (e.g., skin reaction, dysregulation of thermoregulation, etc)
* All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc)
* Pregnant or nursing female patients
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive B-WARM
* Received an investigational agent within 30 days prior to enrollment
* Received any systemic therapy within 21 days prior to planned B-WARM therapy
* Patients may be enrolled on study but at least 21 days should elapse prior to date of B-WARM therapy
* Patients should not have either CT scanning or B-WARM if they have a fever at the time
* Fever should be worked up and treated as appropriate
* Patients should be afebrile for 24 hours prior to scanning or B-WARM therapy
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Anurag Singh
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2013-01198
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 229812
Identifier Type: OTHER
Identifier Source: secondary_id
I 229812
Identifier Type: -
Identifier Source: org_study_id
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