Adult Liver CarcinomaNCT01896778
Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer
A study testing Hyperthermia Treatment and Laboratory Biomarker Analysis in people with Adult Liver Carcinoma and Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Liver Carcinoma, Breast Carcinoma, Colon Carcinoma
- What is being tested?
- Hyperthermia Treatment and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2013to 23 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Adult Liver Carcinoma, Breast Carcinoma, Colon Carcinoma, Kidney Neoplasm, Lung Carcinoma, Malignant Head and Neck Neoplasm
- Being tested
- Hyperthermia Treatment, Laboratory Biomarker Analysis
- Medical subject headings
- Carcinoma, Hepatocellular, Breast Neoplasms, Colonic Neoplasms, Kidney Neoplasms, Lung Neoplasms, Head and Neck Neoplasms, Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermia TreatmentProcedure or surgery
Also called Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia Therapy
Undergo B-WARM
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (B-WARM for 30 minutes) | Experimental | Patients undergo B-WARM at 39 degrees C for 30 minutes. Receives: Procedure: Hyperthermia Treatment; Other: Laboratory Biomarker Analysis |
| Arm II (B-WARM for 2 hours) | Experimental | Patients undergo B-WARM at 39 degrees C for 2 hours. Receives: Procedure: Hyperthermia Treatment; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in tumor vascular (blood flow, blood volume)
The primary analysis will be implemented using an analysis-of-covariance model for both blood flow and blood volume.
Measured: Baseline to 24-88 hours
Secondary outcomes (2)
Changes in tumor vascular measures
Measured: 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
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.
Measured: Up to 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study start4 Oct 2013
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Liver CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anurag Singh, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896778
- Sponsor's protocol ID
- I 229812
- Other IDs
- NCI-2013-01198, I 229812
- Status last verified
- Jul 2022
- First submitted
- 8 Jul 2013
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Warming to Alter [Thermo] Regulation and the Microenvironment [B-WARM] Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT01896778
- Acronym / sponsor ID
- I 229812
- Conditions
- Adult Liver Carcinoma, Breast Carcinoma, Colon Carcinoma, Kidney Neoplasm, Lung Carcinoma, Malignant Head and Neck Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 4 Oct 2013 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (B-WARM for 30 minutes) | Experimental | Procedure: Hyperthermia Treatment, Other: Laboratory Biomarker AnalysisPatients undergo B-WARM at 39 degrees C for 30 minutes. |
| Arm II (B-WARM for 2 hours) | Experimental | Procedure: Hyperthermia Treatment, Other: Laboratory Biomarker AnalysisPatients undergo B-WARM at 39 degrees C for 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperthermia TreatmentAlso: Clinical Hyperthermia, Diathermy, Hyperthermia, Hyperthermia TherapyUndergo B-WARM | Procedure or surgery | Arm I (B-WARM for 30 minutes), Arm II (B-WARM for 2 hours) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (B-WARM for 30 minutes), Arm II (B-WARM for 2 hours) |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anurag Singh principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperthermia Treatment and Laboratory Biomarker Analysis in people with Adult Liver Carcinoma and Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in tumor vascular (blood flow, blood volume) (time frame: Baseline to 24-88 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.