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

Primary Purpose

Adult Liver Carcinoma, Breast Carcinoma, Colon Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperthermia Treatment
Laboratory Biomarker Analysis
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Adult Liver Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I (B-WARM for 30 minutes)

Arm II (B-WARM for 2 hours)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in tumor vascular measures
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.

Full Information

First Posted
July 8, 2013
Last Updated
July 20, 2022
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01896778
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2013 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Liver Carcinoma, Breast Carcinoma, Colon Carcinoma, Kidney Neoplasm, Lung Carcinoma, Malignant Head and Neck Neoplasm, Malignant Neoplasm, Melanoma, Ovarian Neoplasm, Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (B-WARM for 30 minutes)
Arm Type
Experimental
Arm Description
Patients undergo B-WARM at 39 degrees C for 30 minutes.
Arm Title
Arm II (B-WARM for 2 hours)
Arm Type
Experimental
Arm Description
Patients undergo B-WARM at 39 degrees C for 2 hours.
Intervention Type
Procedure
Intervention Name(s)
Hyperthermia Treatment
Other Intervention Name(s)
Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia Therapy
Intervention Description
Undergo B-WARM
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Changes in tumor vascular (blood flow, blood volume)
Description
The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.
Time Frame
Baseline to 24-88 hours
Secondary Outcome Measure Information:
Title
Changes in tumor vascular measures
Time Frame
Baseline to 88-264 hours
Title
Incidence of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Description
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.
Time Frame
Up to 30 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anurag Singh
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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

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