Breast NeoplasmsPhase 2NCT00178802
Chemotherapy With Whole Body Hyperthermia to Treat Resistant Breast, Endometrial, Cervical and Ovarian Cancers
A Phase 2 study testing thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin) in people with Breast Neoplasms and Endometrial Neoplasms, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Endometrial Neoplasms, Cervix Neoplasms
- What is being tested?
- thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1996to Dec 2010
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resistant breast, endometrial, cervix, or ovarian cancer
- No active metastasis to the brain
- No more than 8 previous regimes of Doxil
- Successful completion of preliminary function tests
- Good ECOG score
Who cannot join
- Active metastasis to the brain
- 8 or more previous cycles of Doxil
- Poor completion of preliminary function tests
- Poor ECOG score
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Mild Whole Body Hyperthermia Combined With 5-Fluorouracil/Interferon-a/Liposomal Doxorubicin in Patients With Advanced Malignancy
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:
- if it improves the effect of the chemotherapy drugs,
- if it helps the body fight the cancer cells, and
- 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.
Read the 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 patient's 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 patient's 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 i.v. 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 patient's own doctor's 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 and/or 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.
- Being tested
- thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)
- Keywords
- breast cancer, endometrial cancer, cervical cancer, ovarian cancer
- Medical subject headings
- Breast Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)Other
5-fluorouracil 400 mg/m2 i.v. over 24 hours for 5 days
Doxil (liposomal doxorubicin) 40 mg/m2 over 1 hour
Fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration daily
Low-dose interferon-alpha 100,000 i.u. s.c. daily for the duration of the protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | thermochemotherapy using fever-range whole-body thermal therapy combined with continuous infusion 5-fluorouracil, Doxil, and low-dose interferon-alpha. Receives: Other: thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Measured: 5 years
Response duration
Measured: 5 years
Secondary outcomes (1)
Toxicity
Measured: 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 startJun 1996
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- 24 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
- NCT00178802
- Sponsor's protocol ID
- HSC-MS-01-111
- Other IDs
- HSC-MS-01-111
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Mild Whole Body Hyperthermia Combined With 5-Fluorouracil/Interferon-a/Liposomal Doxorubicin in Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT00178802
- Acronym / sponsor ID
- HSC-MS-01-111
- Keywords
- breast cancer, endometrial cancer, cervical cancer, ovarian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 1996
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (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 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:
- if it improves the effect of the chemotherapy drugs,
- if it helps the body fight the cancer cells, and
- 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 patient's 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 patient's 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 i.v. 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 patient's own doctor's 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 and/or 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)thermochemotherapy using fever-range whole-body thermal therapy combined with continuous infusion 5-fluorouracil, Doxil, and low-dose interferon-alpha. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Resistant breast, endometrial, cervix, or ovarian cancer
- No active metastasis to the brain
- No more than 8 previous regimes of Doxil
- Successful completion of preliminary function tests
- Good ECOG score
Key exclusion criteria (4 listed)
- Active metastasis to the brain
- 8 or more previous cycles of Doxil
- Poor completion of preliminary function tests
- Poor ECOG score
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 |
|---|---|---|
| thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)5-fluorouracil 400 mg/m2 i.v. over 24 hours for 5 days Doxil (liposomal doxorubicin) 40 mg/m2 over 1 hour Fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration daily Low-dose interferon-alpha 100,000 i.u. s.c. daily for the duration of the protocol | Other | 1 |
Primary outcome
Tumor response
Time frame: 5 years
Response duration
Time frame: 5 years
1 secondary outcome
Toxicity
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2010.
- 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 thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin) in people with Breast Neoplasms and Endometrial 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 5 inclusion and 4 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 23 Apr 2010. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 5 years). The study lists 2 primary outcomes in all. 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 23 Apr 2010.