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

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.

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