Recruiting
Phase 2

Hyperthermia with Chemotherapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00178763

Conditions

Pancreatic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Heckel Infrared Radiant Heat Device

cisplatin, gemcitabine, interferon-alpha

thermochemotherapy

Study Details

Brief summary:

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.

Conditions

Pancreatic Neoplasms

Study ID

NCT00178763

Start date

Sep, 2003

Status verified date

Mar, 2011

Completion date

Jun, 2013

Anticipated

Primary completion date

Jun, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

All protocol subjects are treated with fever-range whole-body thermal therapy combined in an optimized schedule with cisplatin + gemcitabine + metronomic low-dose interferon-alpha

Interventions

Heckel Infrared Radiant Heat Device

thermotherapy, maintain a core temperature of 40 degrees centigrade for 6 hours duration

cisplatin, gemcitabine, interferon-alpha

cisplatin 60 mg/m2 administered over 3 hours intravenously 36 hours before heat. gemcitabine 600 mg/m2 administered intravenously over 1 hour during 40 degree heat. interferon-alpha 1 million international units subcutaneously daily during protocol.

thermochemotherapy

fever-range whole-body thermal therapy to 40 degrees centigrade combined with cisplatin 60 mg/m2 + gemcitabine 600 mg/m2 + daily interferon alpha 1 million units.

Primary outcome measure

  • Tumor response, disease-free survival [ Time Frame: 2 months to 5 years ]

Central Contacts and Locations

Central contacts

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Joan M. Bull, M.D.

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Mar 3, 2011

Last verified

Mar, 2011

Keywords

  • Cancer
  • Pancreatic Cancer
  • Pancreas
  • Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2011-03-03.