Pancreatic NeoplasmsPhase 2FR-WB-TTNCT00178763
Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer
A Phase 2 study testing Heckel Infrared Radiant Heat Device, cisplatin, gemcitabine, interferon-alpha and thermochemotherapy in people with Pancreatic Neoplasms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment that includes the entire body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Heckel Infrared Radiant Heat Device, cisplatin, gemcitabine, interferon-alpha and thermochemotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jun 2013
- Phase
- Phase 2
- 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
- Candidate must have biopsy-documented locally advanced or metastatic pancreas cancer
- Must be able to successfully complete preliminary function tests
- Must have a good ECOG score
- Must have two functioning lungs
Who cannot join
- Must not have active metastasis to the brain
- Must not have poor preliminary function tests
- Must not have a low ECOG score
- Must not be taking high-dose corticosteroids
- Must be psychologically stable
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77030
Joan M Bull, M.D., 713-500-6815, Joan.M.Bull@uth.tmc.edu
Esperanza N. Fernandez, N/D, 713-500-6774, Esperanza.N.Fernandez@uth.tmc.edu
About this study
Official title: Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer
Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells can be treated wherever they are throughout the entire body. In this study, we are testing a combination of fever-range thermal therapy combined with chemotherapy to test: 1) the response of metastatic or advanced pancreas cancer to the combined modality treatment of thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the pancreas cancer; and 3) if this treatment is safe for the patient.
This study does not offer thermal therapy alone. Any patient with measurable, inoperable or metastatic pancreatic cancer may be treated; however, the they will need to undergo specific medical tests to make sure this treatment would be safe for them.
We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered, low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size; b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.
Read the detailed description
The treatment cycle begins with 6 hours of intravenous (IV) hydration followed by an infusion of the anti-cancer drug, Cisplatin. In addition, at the beginning of this treatment, you will begin low-dose Interferon-alpha injections for the entire duration of your participation in this study. The drug, Interferon-alpha, interrupts the division of cancer cells, destroys tumor blood vessels, and slows tumor growth.
Forty-eight hours after the Cisplatin infusion, you will be treated with fever-range thermal therapy (whole-body hyperthermia, or heat). When your core body temperature reaches 104oF (40oC), a 30-minute (IV) infusion of another chemotherapy drug, gemcitabine (Gemzar) is given. Cisplatin, low-dose Interferon-a and gemcitabine are the only chemotherapy drugs used in this treatment plan. No other chemotherapy drugs are allowed to be given under this treatment plan.
The fever-range whole-body heat treatment is carried out while you are lightly sedated. With this sedation, you will be awake and be able to talk during the treatment, however you will not be uncomfortable. This sedation is used to reduce any discomfort of the 6-hour heat treatment procedure yet will allow you to speak to your nurses.
Your body temperature is raised to 104oF (40oC) over a period of 60-120 minutes. When the body first reaches the target 104oF, we administer the gemcitabine chemotherapy over 60 minutes and continue to maintain the 104 oF body temperature for six hours. At the conclusion of the six hours of thermal treatment, you will be cooled to your normal body temperature, which takes about 30-45 minutes. The entire treatment lasts approximately 8 hours. After the treatment is completed, we will observe you for 2 to 12 hours to make sure you have tolerated the treatment without a problem.
You will continue the low-dose Interferon-alpha. Additionally, you will be given 5-10 days of Leukine (sargramostim) cytokine injections usually beginning 3-5 days after receiving chemotherapy to help support the immune system by helping the body create more white blood cells. White blood cells are important to help your body fight infection.
After treatment, you will need a complete blood count with platelet and differential count each week. These lab studies can be done at your own doctor's office or hospital as long as you make sure that the results are faxed to us. They can also be done in our clinic. We will see you again in approximately three to four weeks and the treatment cycle will be repeated.
We always attempt to perform at least two thermo-chemotherapy cycles. After the second treatment, CT and/or MRI scans are repeated to see if your cancer is smaller. These scans, along with a physical examination and the lab studies, are used to determine if additional heat treatments will be performed. Additional treatments continue based on how well you respond to the treatment. We limit to the number of heat treatments a patient may have using these chemotherapy drugs to a total of six treatments.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Heckel Infrared Radiant Heat Device, cisplatin, gemcitabine, interferon-alpha, thermochemotherapy
- Keywords
- Cancer, Pancreatic Cancer, Pancreas, Neoplasms
- Medical subject headings
- Pancreatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heckel Infrared Radiant Heat DeviceDevice
Also called Infrared Radiant Heat Device
thermotherapy, maintain a core temperature of 40 degrees centigrade for 6 hours duration
cisplatin, gemcitabine, interferon-alphaOther
Also called Cisplatin, Gemzar, Pegasys
cisplatin 60 mg/m2 administered over 3 hours intravenously 36 hours before heat. gemcitabine 600 mg/m2 administered intravenously over 1 hour during 40 degree heat. interferon-alpha 1 million international units subcutaneously daily during protocol.
thermochemotherapyOther
Also called cisplatin, Cisplatin, gemcitabine, Gemzar, interferon-alpha, Roferon
fever-range whole-body thermal therapy to 40 degrees centigrade combined with cisplatin 60 mg/m2 + gemcitabine 600 mg/m2 + daily interferon alpha 1 million units.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All protocol subjects are treated with fever-range whole-body thermal therapy combined in an optimized schedule with cisplatin + gemcitabine + metronomic low-dose interferon-alpha Receives: Device: Heckel Infrared Radiant Heat Device; Other: cisplatin, gemcitabine, interferon-alpha; Other: thermochemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response, disease-free survival
Measured: 2 months to 5 years
Secondary outcomes (1)
Allow inoperable pancreatic cancer to be converted to operable disease
Measured: 2 months to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionJun 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Joan M Bull, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00178763
- Sponsor's protocol ID
- HSC-MS-02-117
- Acronym
- FR-WB-TT
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2005
- Last updated
- 3 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Cisplatin + Gemcitabine in Combination With Mild, Fever-Range Whole-Body Hyperthermia to Treat Patients With Advanced, Inoperable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT00178763
- Acronym / sponsor ID
- FR-WB-TT / HSC-MS-02-117
- Conditions
- Pancreatic Neoplasms
- Keywords
- Cancer, Pancreatic Cancer, Pancreas, Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 15 Sep 2005 (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.
Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells can be treated wherever they are throughout the entire body. In this study, we are testing a combination of fever-range thermal therapy combined with chemotherapy to test: 1) the response of metastatic or advanced pancreas cancer to the combined modality treatment of thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the pancreas cancer; and 3) if this treatment is safe for the patient.
This study does not offer thermal therapy alone. Any patient with measurable, inoperable or metastatic pancreatic cancer may be treated; however, the they will need to undergo specific medical tests to make sure this treatment would be safe for them.
We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered, low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size; b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.
Detailed description
The treatment cycle begins with 6 hours of intravenous (IV) hydration followed by an infusion of the anti-cancer drug, Cisplatin. In addition, at the beginning of this treatment, you will begin low-dose Interferon-alpha injections for the entire duration of your participation in this study. The drug, Interferon-alpha, interrupts the division of cancer cells, destroys tumor blood vessels, and slows tumor growth.
Forty-eight hours after the Cisplatin infusion, you will be treated with fever-range thermal therapy (whole-body hyperthermia, or heat). When your core body temperature reaches 104oF (40oC), a 30-minute (IV) infusion of another chemotherapy drug, gemcitabine (Gemzar) is given. Cisplatin, low-dose Interferon-a and gemcitabine are the only chemotherapy drugs used in this treatment plan. No other chemotherapy drugs are allowed to be given under this treatment plan.
The fever-range whole-body heat treatment is carried out while you are lightly sedated. With this sedation, you will be awake and be able to talk during the treatment, however you will not be uncomfortable. This sedation is used to reduce any discomfort of the 6-hour heat treatment procedure yet will allow you to speak to your nurses.
Your body temperature is raised to 104oF (40oC) over a period of 60-120 minutes. When the body first reaches the target 104oF, we administer the gemcitabine chemotherapy over 60 minutes and continue to maintain the 104 oF body temperature for six hours. At the conclusion of the six hours of thermal treatment, you will be cooled to your normal body temperature, which takes about 30-45 minutes. The entire treatment lasts approximately 8 hours. After the treatment is completed, we will observe you for 2 to 12 hours to make sure you have tolerated the treatment without a problem.
You will continue the low-dose Interferon-alpha. Additionally, you will be given 5-10 days of Leukine (sargramostim) cytokine injections usually beginning 3-5 days after receiving chemotherapy to help support the immune system by helping the body create more white blood cells. White blood cells are important to help your body fight infection.
After treatment, you will need a complete blood count with platelet and differential count each week. These lab studies can be done at your own doctor's office or hospital as long as you make sure that the results are faxed to us. They can also be done in our clinic. We will see you again in approximately three to four weeks and the treatment cycle will be repeated.
We always attempt to perform at least two thermo-chemotherapy cycles. After the second treatment, CT and/or MRI scans are repeated to see if your cancer is smaller. These scans, along with a physical examination and the lab studies, are used to determine if additional heat treatments will be performed. Additional treatments continue based on how well you respond to the treatment. We limit to the number of heat treatments a patient may have using these chemotherapy drugs to a total of six treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Heckel Infrared Radiant Heat Device, Other: cisplatin, gemcitabine, interferon-alpha, Other: thermochemotherapyAll protocol subjects are treated with fever-range whole-body thermal therapy combined in an optimized schedule with cisplatin + gemcitabine + metronomic low-dose interferon-alpha |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidate must have biopsy-documented locally advanced or metastatic pancreas cancer
- Must be able to successfully complete preliminary function tests
- Must have a good ECOG score
- Must have two functioning lungs
Key exclusion criteria (5 listed)
- Must not have active metastasis to the brain
- Must not have poor preliminary function tests
- Must not have a low ECOG score
- Must not be taking high-dose corticosteroids
- Must be psychologically stable
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 |
|---|---|---|
| Heckel Infrared Radiant Heat DeviceAlso: Infrared Radiant Heat Devicethermotherapy, maintain a core temperature of 40 degrees centigrade for 6 hours duration | Device | 1 |
| cisplatin, gemcitabine, interferon-alphaAlso: Cisplatin, Gemzar, Pegasyscisplatin 60 mg/m2 administered over 3 hours intravenously 36 hours before heat. gemcitabine 600 mg/m2 administered intravenously over 1 hour during 40 degree heat. interferon-alpha 1 million international units subcutaneously daily during protocol. | Other | 1 |
| thermochemotherapyAlso: cisplatin, Cisplatin, gemcitabine, Gemzar, interferon-alpha, Roferonfever-range whole-body thermal therapy to 40 degrees centigrade combined with cisplatin 60 mg/m2 + gemcitabine 600 mg/m2 + daily interferon alpha 1 million units. | Other | 1 |
Primary outcome
Tumor response, disease-free survival
Time frame: 2 months to 5 years
1 secondary outcome
Allow inoperable pancreatic cancer to be converted to operable disease
Time frame: 2 months to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
- Related InfoLink provided by the sponsor.
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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.
Joan M Bull, M.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heckel Infrared Radiant Heat Device, cisplatin, gemcitabine, interferon-alpha and thermochemotherapy in people with Pancreatic Neoplasms, run by The University of Texas Health Science Center, Houston 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Mar 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joan M Bull, M.D. (713-500-6820, Joan.M.Bull@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response, disease-free survival (time frame: 2 months to 5 years). 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 3 Mar 2011.