Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study

Conditions
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Adult Liver Carcinoma, Breast Carcinoma, Colon Carcinoma, Kidney Neoplasm, Lung Carcinoma, Malignant Head and Neck Neoplasm, Malignant Neoplasm, Melanoma, Ovarian Neoplasm, Soft Tissue Sarcoma

Intervention / Treatment
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* Procedure: Hyperthermia Treatment
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a variety of malignancies (i.e., melanoma, sarcoma, colon, head and neck, renal, breast, lung, ovary, liver) 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 prior myocardial infarction or arrhythmia 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (B-WARM for 30 minutes)<br>Patients undergo B-WARM at 39 degrees C for 30 minutes. | Procedure: Hyperthermia Treatment<br>* Undergo B-WARM<br>* Other names: Hyperthermia Therapy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|
| Experimental: Arm II (B-WARM for 2 hours)<br>Patients undergo B-WARM at 39 degrees C for 2 hours. | Procedure: Hyperthermia Treatment<br>* Undergo B-WARM<br>* Other names: Hyperthermia Therapy;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 24-88 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in tumor vascular measures |  | 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. | Up to 30 days post-treatment |