Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2003 |
| End Date: | June 2013 |
| Contact: | Joan M Bull, M.D. |
| Email: | Joan.M.Bull@uth.tmc.edu |
| Phone: | 713-500-6820 |
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.
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.
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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