Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer

NCT00178763 | Unknown Phase 2 DMC

• 1 other identifier: HSC-MS-02-117
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Cancer; Pancreatic Cancer; Pancreas; Neoplasms

Outcome Measures

Primary Outcomes (1)

• Tumor response, disease-free survival

  2 months to 5 years

Secondary Outcomes (1)

• Allow inoperable pancreatic cancer to be converted to operable disease

  2 months to 5 years

Study Arms (1)

1

EXPERIMENTAL

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

Device: Heckel Infrared Radiant Heat Device; Other: cisplatin, gemcitabine, interferon-alpha; Other: thermochemotherapy

Interventions

Heckel Infrared Radiant Heat Device DEVICE

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

Also known as: Infrared Radiant Heat Device

1

cisplatin, gemcitabine, interferon-alpha OTHER

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.

Also known as: Cisplatin, Gemzar, Pegasys

1

thermochemotherapy OTHER

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.

Also known as: cisplatin, Cisplatin, gemcitabine, Gemzar, interferon-alpha, Roferon

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Interventions

Cisplatin; Gemcitabine; Interferon-alpha; peginterferon alfa-2a; Interferon alpha-2

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Joan M Bull, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan M Bull, M.D.

CONTACT

713-500-6820; Joan.M.Bull@uth.tmc.edu

Esperanza N. Fernandez

CONTACT

713-500-6774; Esperanza.N.Fernandez@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2003
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 3, 2011

Record last verified: 2011-03

Locations

US (1)