Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00178802
Status:
UNKNOWN
Last Update Posted:
2010-04-23
First Post:
2005-09-13
Brief Title:
Chemotherapy With Whole Body Hyperthermia to Treat Resistant Breast Endometrial Cervical and Ovarian Cancers
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Phase II Study of Mild Whole Body Hyperthermia Combined With 5-FluorouracilInterferon-aLiposomal Doxorubicin in Patients With Advanced Malignancy
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
Thermal therapy hyperthermia of heat can increase the effect of chemotherapy treatments By itself thermal therapy can also kill cancer cells By using thermal therapy to treat the whole body the investigators can treat cancer cells wherever they are throughout the entire body In this study the investigators are testing the combination of thermal therapy combined with chemotherapy to see
1 if it improves the effect of the chemotherapy drugs
2 if it helps the body fight the cancer cells and
3 if this treatment is safe for the patient
This study does not offer heat treatment alone Any patient with advanced or metastatic breast or endometrial cancer resistant to standard treatment may be treated with the phase II protocol therapy however the patient will need to undergo some medical tests to make sure this treatment would be safe for them
1 if it improves the effect of the chemotherapy drugs
2 if it helps the body fight the cancer cells and
3 if this treatment is safe for the patient
This study does not offer heat treatment alone Any patient with advanced or metastatic breast or endometrial cancer resistant to standard treatment may be treated with the phase II protocol therapy however the patient will need to undergo some medical tests to make sure this treatment would be safe for them
Detailed Description:
Once a patient has been accepted for this study the patient will need to have a Central Venous line CV line or port if they do not already have one this may be placed by the patients own doctor or it can be done here
The treatment cycle begins with a continuous 24-hour intravenous infusion of 5-Fluorouracil 5-FU over a period of 5 days This regimen will end 24 hours prior to the scheduled heat treatment In addition at the beginning of the treatment the patient will begin daily low-dose Interferon-alpha injections for the duration of their participation in this study The drug Interferon-alpha is given to stimulate the immune system and to decrease tumor microvasculature Interferon-alpha also interrupts the division of cancer cells and slows tumor growth
The fever-range whole-body heat treatment is performed while the patient is under light conscious sedation With this type of sedation the patient is awake during the treatment but not uncomfortable This type of sedation method is used to reduce the discomfort of the 6-hour heat treatment procedure yet allows the patient to respond to verbal commands
The patients body temperature is elevated to 40oC 104oF over a period of 60-90 minutes When the body reaches the target 40 oC we will maintain that body temperature for six hours At the conclusion of the six hours of heat treatment the patient will be cooled to their normal body temperature over 30-45 minutes The Doxil chemotherapy will then be infused iv over a period of 2 hours
The entire procedure lasts approximately 8-10 hours After the treatment is completed we observe the patient for 2 to 12 hours to make sure the treatment has been well tolerated
The patient will continue the daily low-dose Interferon-alpha injections Additionally the patient will be given daily 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 which are important in helping your body fight infection
After treatment the patient will need a complete blood count with platelet and differential count each week These lab studies can be done at the patients own doctors office as long as the results are faxed to us They can also be done in our clinic The treatment cycle will be repeated every 28 days
We always attempt to perform at least two thermochemotherapy cycles After the second treatment CT andor MRI scans are repeated to see if the tumor has changed 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 a patient responds to the treatment There is no limit to the number of heat treatments a patient may have
The treatment cycle begins with a continuous 24-hour intravenous infusion of 5-Fluorouracil 5-FU over a period of 5 days This regimen will end 24 hours prior to the scheduled heat treatment In addition at the beginning of the treatment the patient will begin daily low-dose Interferon-alpha injections for the duration of their participation in this study The drug Interferon-alpha is given to stimulate the immune system and to decrease tumor microvasculature Interferon-alpha also interrupts the division of cancer cells and slows tumor growth
The fever-range whole-body heat treatment is performed while the patient is under light conscious sedation With this type of sedation the patient is awake during the treatment but not uncomfortable This type of sedation method is used to reduce the discomfort of the 6-hour heat treatment procedure yet allows the patient to respond to verbal commands
The patients body temperature is elevated to 40oC 104oF over a period of 60-90 minutes When the body reaches the target 40 oC we will maintain that body temperature for six hours At the conclusion of the six hours of heat treatment the patient will be cooled to their normal body temperature over 30-45 minutes The Doxil chemotherapy will then be infused iv over a period of 2 hours
The entire procedure lasts approximately 8-10 hours After the treatment is completed we observe the patient for 2 to 12 hours to make sure the treatment has been well tolerated
The patient will continue the daily low-dose Interferon-alpha injections Additionally the patient will be given daily 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 which are important in helping your body fight infection
After treatment the patient will need a complete blood count with platelet and differential count each week These lab studies can be done at the patients own doctors office as long as the results are faxed to us They can also be done in our clinic The treatment cycle will be repeated every 28 days
We always attempt to perform at least two thermochemotherapy cycles After the second treatment CT andor MRI scans are repeated to see if the tumor has changed 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 a patient responds 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HSC-MS-01-111 | None | None | None |