Trial record 17 of 123 for:    oxygen therapy OR supplemental oxygen | Open Studies | NIH, U.S. Fed

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 April 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborators:
Braun Foundation
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01896778
First received: July 8, 2013
Last updated: April 14, 2014
Last verified: April 2014
  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 Primary Liver Cancer
Breast Cancer
Colon Cancer
Head and Neck Cancer
Kidney Tumor
Lung Cancer
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 (ANCOVA) 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 ]

Estimated Enrollment: 90
Study Start Date: October 2013
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (B-WARM at 38 degrees C)
Patients undergo B-WARM at 38 degrees C for 2 hours.
Procedure: hyperthermia treatment
Undergo B-WARM at 38 degrees C
Other Name: hyperthermia
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (B-WARM at 39 degrees C)
Patients undergo B-WARM at 39 degrees C for 2 hours.
Procedure: hyperthermia treatment
Undergo B-WARM at 39 degrees C
Other Name: hyperthermia
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility and efficacy of 2 different 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.

II. To determine if there is a correlation between computed tomography (CT) scans and optical/thermal imaging in terms of changes in blood flow and volume before and after therapy.

OUTLINE: Patients are randomized to 1of 2 arms.

ARM I: Patients undergo B-WARM at 38 degrees Celsius (C) for 2 hours.

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

After completion of study, patients are followed up at 30 minutes, 40-88 hours, 88-264 hours, and 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 by 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
Braun Foundation
Investigators
Principal Investigator: Anurag Singh Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01896778     History of Changes
Other Study ID Numbers: I 229812, NCI-2013-01198, P30CA016056
Study First Received: July 8, 2013
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Colonic Neoplasms
Head and Neck Neoplasms
Kidney Neoplasms
Liver Neoplasms
Lung Neoplasms
Melanoma
Ovarian Neoplasms
Sarcoma
Neoplasms by Site
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Liver Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014