Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178698
Status:
UNKNOWN
Last Update Posted:
2011-03-03
First Post:
2005-09-13
Brief Title:
HyperthermiaThermal Therapy With Chemotherapy to Treat Inoperable or Metastatic Tumors
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
A Phase II Clinical Trial of Cisplatin Gemcitabine HCl GEM Low-Dose Metronomic Interferon-a IFN-a Combined With Fever-Range Whole-Body Thermal Therapy FR-WB-TT in Patients With Metastaticor Locally Advanced Malignancies Small-Cell Lung Cancer Neuroendocrine Cancer Gastric 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-TTche
Brief Summary:
Thermal therapy hyperthermia or heat increases chemotherapy cancer cell kill By itself thermal therapy can also kill cancer cells Whole body thermal therapy is a systemic treatment whole-body fever-range thermal therapy can safely treat cancer cells wherever they are throughout the entire body In this study we are testing the combination of fever-range heat treatment and chemotherapy to test 1 The response of three types of cancer small-cell lung neuroendocrine cancer lung cancer and gastric cancer to the thermo-chemotherapy improves cancer response compared to the effect of only chemotherapy drugs in current use 2 whether the thermo-chemotherapy treatment helps the persons own body fight the cancer cells and 3 whether this treatment is safe and comfortable for the patient This study does not offer heat treatment alone Any patient with inoperable or metastatic small cell lung cancer neuroendocrine cancer any organ gastric cancer or lung cancer can be treated with the Phase II protocol therapy however the patient will need to undergo selected medical tests to make sure this treatment would be safe for them
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 that will continue for the entire duration of your participation in this study The low-dose Interferon-alpha interrupts the division of cancer cells kills blood vessels feeding the cancer and slows tumor growth and as well boosts the bodys immunity against the cancer
Thirty-six hours after the cisplatin infusion you will be treated with fever-range thermal therapy whole-body hyperthermia The fever-range whole-body thermal therapy enhances the effect of chemotherapy drugs against the cancer and is thought to also boost your own immune response against the cancer When the core body temperature reaches 104oF 40oC a 30-minute IV infusion of another chemotherapy drug gemcitabine Gemzar is given Cisplatin low-dose interferon-alpha and gemcitabine are the only chemotherapy drugs used in this treatment protocol No other chemotherapy drugs are allowed to be given under this treatment plan
The fever-range whole-body heat treatment is performed while you are lightly sedated With this type of sedation you are awake and can talk during the treatment but you are not uncomfortable This type of sedation method is used to reduce any discomfort of the 6-hour heat treatment procedure yet allows you to talk to the nurses
Your body temperature is raised to 104oF 40oC over a period of 60-120 minutes When your body first reaches the target 104oF we administer the gemcitabine chemotherapy over 60 minutes and continue to maintain the 104oF body temperature for six hours At the conclusion of the six hours of thermochemotherapy you will be cooled off 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
You will continue the low-dose Interferon-alpha injections once weekly Additionally you will be given 5-10 days of Leukine sargramostim GM-CSF injections beginning 3-5 days after receiving chemotherapy to help support your immune system by helping your body create more white blood cells which are important in helping 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 your response to the treatment There is no limit to the number of heat treatments a patient may have
Thirty-six hours after the cisplatin infusion you will be treated with fever-range thermal therapy whole-body hyperthermia The fever-range whole-body thermal therapy enhances the effect of chemotherapy drugs against the cancer and is thought to also boost your own immune response against the cancer When the core body temperature reaches 104oF 40oC a 30-minute IV infusion of another chemotherapy drug gemcitabine Gemzar is given Cisplatin low-dose interferon-alpha and gemcitabine are the only chemotherapy drugs used in this treatment protocol No other chemotherapy drugs are allowed to be given under this treatment plan
The fever-range whole-body heat treatment is performed while you are lightly sedated With this type of sedation you are awake and can talk during the treatment but you are not uncomfortable This type of sedation method is used to reduce any discomfort of the 6-hour heat treatment procedure yet allows you to talk to the nurses
Your body temperature is raised to 104oF 40oC over a period of 60-120 minutes When your body first reaches the target 104oF we administer the gemcitabine chemotherapy over 60 minutes and continue to maintain the 104oF body temperature for six hours At the conclusion of the six hours of thermochemotherapy you will be cooled off 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
You will continue the low-dose Interferon-alpha injections once weekly Additionally you will be given 5-10 days of Leukine sargramostim GM-CSF injections beginning 3-5 days after receiving chemotherapy to help support your immune system by helping your body create more white blood cells which are important in helping 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 your response to the treatment There is no limit to the number of heat treatments a patient may have
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