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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by The University of Texas Health Science Center, Houston.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178802
First received: September 13, 2005
Last updated: April 22, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Endometrial Neoplasms
Cervix Neoplasms
Ovarian Neoplasms
Other: thermochemotherapy (with 5-fluorouracil/interferon-a/liposomal doxorubicin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Mild Whole Body Hyperthermia Combined With 5-Fluorouracil/Interferon-a/Liposomal Doxorubicin in Patients With Advanced Malignancy

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Tumor response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Response duration [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 1996
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178802

Locations
United States, Texas
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Joan M Bull, M.D. The University of Texas Health Science Center, Houston
  More Information

Additional Information:
No publications provided

Responsible Party: Joan M.C Bull, M.D., The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178802     History of Changes
Other Study ID Numbers: HSC-MS-01-111, HSC-MS-01-111
Study First Received: September 13, 2005
Last Updated: April 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
breast cancer
endometrial cancer
cervical cancer
ovarian cancer

Additional relevant MeSH terms:
Neoplasms
Breast Neoplasms
Ovarian Neoplasms
Fever
Endometrial Neoplasms
Uterine Cervical Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Body Temperature Changes
Signs and Symptoms
Uterine Neoplasms
Uterine Diseases
Uterine Cervical Diseases
Liposomal doxorubicin
Interferons
Doxorubicin
Fluorouracil
Interferon-alpha
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014