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Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer

NCT00178763 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2011-03-03

No results posted yet for this study

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

Interventions

DEVICE

Heckel Infrared Radiant Heat Device

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

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Joan M Bull, M.D. · The University of Texas Health Science Center, Houston

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2012-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00178763 on ClinicalTrials.gov