Chemotherapy With Whole Body Hyperthermia to Treat Resistant Breast, Endometrial, Cervical and Ovarian Cancers

April 22, 2010 updated by: The University of Texas Health Science Center, Houston

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:

  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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Active metastasis to the brain
  • 8 or more previous cycles of Doxil
  • Poor completion of preliminary function tests
  • Poor ECOG score

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
thermochemotherapy using fever-range whole-body thermal therapy combined with continuous infusion 5-fluorouracil, Doxil, and low-dose interferon-alpha.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response duration
Time Frame: 5 years
5 years
Tumor response
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Joan M Bull, M.D., The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2010

Last Update Submitted That Met QC Criteria

April 22, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-01-111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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