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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01896778
First received: July 8, 2013
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Changes in tumor vascular (blood flow, blood volume) [ Time Frame: Baseline to 24-88 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 88-264 hours ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896778

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@RoswellPark.org   
Principal Investigator: Anurag K. Singh         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01896778     History of Changes
Other Study ID Numbers: I 229812  NCI-2013-01198  I 229812  P30CA016056 
Study First Received: July 8, 2013
Last Updated: March 22, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma, Hepatocellular
Head and Neck Neoplasms
Kidney Neoplasms
Lung Neoplasms
Neoplasms
Ovarian Neoplasms
Sarcoma
Adenocarcinoma
Adnexal Diseases
Breast Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Kidney Diseases
Liver Diseases
Liver Neoplasms
Lung Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on May 26, 2016