Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer

Status unconfirmed · Phase 2

Conditions studied: Pancreatic Neoplasms

In brief

Thermal therapy (hyperthermia, or heat) enhances the chemotherapy anti-tumor kill. Thermal therapy by itself also kills cancer cells. Whole-body thermotherapy is a systemic treatment that includes the entire body. By using fever-range whole-body thermal therapy, cancer cells can be treated wherever they are throughout the entire body. In this study, we are testing a combination of fever-range thermal therapy combined with chemotherapy to test: 1) the response of metastatic or advanced pancreas cancer to the combined modality treatment of thermotherapy and selected chemotherapy; 2) whether it helps the body immunity fight the pancreas cancer; and 3) if this treatment is safe for the patient. This study does not offer thermal therapy alone. Any patient with measurable, inoperable or metastatic pancreatic cancer may be treated; however, the they will need to undergo specific medical tests to make sure this treatment would be safe for them. We hypothesize that a combined-modality therapy using fever-range whole-body hyperthermia (FR-WBH; temperature = 40 o C; duration = 6 h), administered in an optimized time/sequence schedule with cisplatin, gemcitabine HCl (gemcitabine), and metronomically administered, low-dose interferon-alpha (IFN-alpha) to patients with inoperable or metastatic pancreas cancer, will, without inducing intolerable toxicity: a.) decrease the pancreatic cancer size; b.) improve quality of life; c.) enhance the immune response against the cancer; d.) increase survival; and e.) allow inoperable pancreatic cancer to be converted to operable disease.

Key facts

Study ID

NCT00178763

Run by

The University of Texas Health Science Center, Houston

People needed

36

Starts

2003-09-01

Expected to finish

2013-06-01

Last updated by the study team

2011-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Candidate must have biopsy-documented locally advanced or metastatic pancreas cancer
• Must be able to successfully complete preliminary function tests
• Must have a good ECOG score
• Must have two functioning lungs

You may not qualify if…

• Must not have active metastasis to the brain
• Must not have poor preliminary function tests
• Must not have a low ECOG score
• Must not be taking high-dose corticosteroids
• Must be psychologically stable

Where it is running

• Memorial Hermann Hospital — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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