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

Roswell Park Comprehensive Cancer Center

Status: Completed

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

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Hyperthermia Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01896778

I 229812 (Other Identifier)

NCI-2013-01198 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Arm I (B-WARM for 30 minutes)

Experimental group

Description:

Patients undergo B-WARM at 39 degrees C for 30 minutes.

Treatment:

Procedure: Hyperthermia Treatment

Other: Laboratory Biomarker Analysis

Arm II (B-WARM for 2 hours)

Experimental group

Description:

Patients undergo B-WARM at 39 degrees C for 2 hours.

Treatment:

Procedure: Hyperthermia Treatment

Other: Laboratory Biomarker Analysis