Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Roswell Park Cancer Institute
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
