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

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ClinicalTrials.gov Identifier: NCT01896778
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : February 27, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Description
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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 Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 4, 2013
Actual Primary Completion Date : February 23, 2018
Actual Study Completion Date : February 23, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in tumor vascular measures [ Time Frame: Baseline to 88-264 hours ]
  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896778


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Anurag Singh Roswell Park Cancer Institute
More Information
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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01896778     History of Changes
Other Study ID Numbers: 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 )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Carcinoma
Sarcoma
Breast Neoplasms
Head and Neck Neoplasms
Ovarian Neoplasms
Kidney Neoplasms
Carcinoma, Hepatocellular
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases