This randomized pilot clinical trial studies body warming in improving blood flow and oxygen delivery to tumors in patients with cancer. Heating tumor cells to several degrees above normal body temperature may kill tumor cells.
PRIMARY OBJECTIVES: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
9
Undergo B-WARM
Correlative studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Changes in tumor vascular (blood flow, blood volume)
The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.
Time frame: Baseline to 24-88 hours
Changes in tumor vascular measures
Time frame: Baseline to 88-264 hours
Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
The frequency of toxicities will be tabulated by grade across all dose levels and cycles. The frequency of toxicities will also be tabulated for the dose estimated to be the maximum tolerated dose.
Time frame: Up to 30 days post-treatment
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