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NCT Number: NCT01896778

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

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.

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Key information

Conditions

Adult Liver Carcinoma Adenocarcinoma Adnexal Diseases Breast Carcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Hepatocellular Colon Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasm Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Carcinoma Lung Diseases Lung Neoplasms Male Urogenital Diseases Malignant Head and Neck Neoplasm Malignant Neoplasm Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Ovarian Diseases Ovarian Neoplasm Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Soft Tissue Sarcoma Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperthermia Treatment

Procedure

Undergo B-WARM

Other names: Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia Therapy

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 11, 2013
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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