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

Sponsor

Roswell Park Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01896778

Collaborator

(none)

Enrollment

Location

Arms

52.7

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adult Liver Carcinoma Breast Carcinoma Colon Carcinoma Kidney Neoplasm Lung Carcinoma Malignant Head and Neck Neoplasm Malignant Neoplasm Melanoma Ovarian Neoplasm Soft Tissue Sarcoma	Procedure: Hyperthermia Treatment Other: Laboratory Biomarker Analysis	N/A

Detailed Description

PRIMARY OBJECTIVES:

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:

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 Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 4, 2013

Actual Primary Completion Date :

Feb 23, 2018

Actual Study Completion Date :

Feb 23, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm I (B-WARM for 30 minutes)

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

Procedure: Hyperthermia Treatment

Undergo B-WARM

Other Names:

Clinical Hyperthermia

Diathermy

Hyperthermia

Hyperthermia Therapy

Other: Laboratory Biomarker Analysis

Correlative studies

Experimental: Arm II (B-WARM for 2 hours)

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

Procedure: Hyperthermia Treatment

Undergo B-WARM

Other Names:

Clinical Hyperthermia

Diathermy

Hyperthermia

Hyperthermia Therapy

Other: Laboratory Biomarker Analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

Changes in tumor vascular (blood flow, blood volume) [Baseline to 24-88 hours]
The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.

Secondary Outcome Measures

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 [Up to 30 days post-treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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