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

This study is currently recruiting participants.
Verified September 2017 by Roswell Park Cancer Institute
Sponsor:
ClinicalTrials.gov Identifier:
NCT01896778
First Posted: July 11, 2013
Last Update Posted: September 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
July 8, 2013
July 11, 2013
September 28, 2017
October 4, 2013
April 11, 2018   (Final data collection date for primary outcome measure)
Changes in tumor vascular (blood flow, blood volume) [ Time Frame: Baseline to 24-88 hours ]
The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.
Changes in tumor vascular (blood flow, blood volume) [ Time Frame: Baseline to 24-88 hours ]
The primary analysis will be implemented using an analysis-of-covariance (ANCOVA) model for both blood flow and blood volume.
Complete list of historical versions of study NCT01896778 on ClinicalTrials.gov Archive Site
  • Changes in tumor vascular measures [ Time Frame: 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 [ Time Frame: 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.
Changes in tumor vascular measures [ Time Frame: Baseline to 88-264 hours ]
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • 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
    Undergo B-WARM
    Other Names:
    • Clinical Hyperthermia
    • Diathermy
    • Hyperthermia
    • Hyperthermia Therapy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Experimental: Arm I (B-WARM for 30 minutes)
    Patients undergo B-WARM at 39 degrees C for 30 minutes.
    Interventions:
    • Procedure: Hyperthermia Treatment
    • Other: Laboratory Biomarker Analysis
  • Experimental: Arm II (B-WARM for 2 hours)
    Patients undergo B-WARM at 39 degrees C for 2 hours.
    Interventions:
    • Procedure: Hyperthermia Treatment
    • Other: Laboratory Biomarker Analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
April 11, 2019
April 11, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
United States
 
 
NCT01896778
I 229812
NCI-2013-01198 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
I 229812 ( Other Identifier: Roswell Park Cancer Institute )
P30CA016056 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
Roswell Park Cancer Institute
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP