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

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Soft Tissue Sarcoma; Breast Carcinoma; Lung Carcinoma; Malignant Neoplasm; Colon Carcinoma; Ovarian Neoplasm; Malignant Head and Neck Neoplasm; Adult Liver Carcinoma; Kidney Neoplasm
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Procedure: Hyperthermia Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2013
• Primary Completion (Actual): February 23, 2018
• Study Completion (Actual): February 23, 2018

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Breast Diseases; Liver Diseases; Liver Neoplasms; Neoplasms; Sarcoma; Kidney Neoplasms; Breast Neoplasms; Head and Neck Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Ovarian Neoplasms
• Other Study ID Numbers: I 229812 (Other Identifier: Roswell Park Cancer Institute); NCI-2013-01198 (Registry Identifier: CTRP (Clinical Trial Reporting Program))