Clinical trial NCT01896778: Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
Official title: Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Liver Carcinoma
Breast Carcinoma
Colon Carcinoma
Kidney Neoplasm
Lung Carcinoma
Malignant Head and Neck Neoplasm
Malignant Neoplasm
Melanoma
Ovarian Neoplasm
Soft Tissue Sarcoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in tumor vascular (blood flow, blood volume)
timeFrame: Baseline to 24-88 hours
Secondary outcomes:
measure: Changes in tumor vascular measures
timeFrame: Baseline to 88-264 hours
measure: Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
timeFrame: Up to 30 days post-treatment
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag Singh
role: PRINCIPAL_INVESTIGATOR
References: