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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896778
• Other study ID #: I 229812
• Secondary ID: NCI-2013-01198I
• Status: Completed
• Phase: N/A
• Start date: October 4, 2013
• Est. completion date: February 23, 2018

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Liver Carcinoma
• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Carcinoma, Hepatocellular
• Colon Carcinoma
• Head and Neck Neoplasms
• Kidney Neoplasm
• Kidney Neoplasms
• Lung Carcinoma
• Malignant Head and Neck Neoplasm
• Malignant Neoplasm
• Melanoma
• Neoplasms
• Ovarian Neoplasm
• Ovarian Neoplasms
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Procedure:
• Hyperthermia Treatment
Undergo B-WARM

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in tumor vascular measures		Baseline to 88-264 hours
Secondary	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