Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178763
Status:
UNKNOWN
Last Update Posted:
2011-03-03
First Post:
2005-09-13
Brief Title:
Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2011-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FR-WB-TT
Brief 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 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 timesequence 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
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 timesequence 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 doctors 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 andor 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
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 doctors 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None