NCT00178698

Brief Summary

Thermal therapy (hyperthermia, or heat) increases chemotherapy cancer cell kill. By itself, thermal therapy can also kill cancer cells. Whole body thermal therapy is a systemic treatment; whole-body fever-range thermal therapy can safely treat cancer cells wherever they are throughout the entire body. In this study, we are testing the combination of fever-range heat treatment and chemotherapy to test 1) The response of three types of cancer (small-cell lung, neuroendocrine cancer, lung cancer, and gastric cancer) to the thermo-chemotherapy improves cancer response compared to the effect of only chemotherapy drugs in current use; 2) whether the thermo-chemotherapy treatment helps the person's own body fight the cancer cells; and 3) whether this treatment is safe and comfortable for the patient. This study does not offer heat treatment alone. Any patient with inoperable or metastatic small cell lung cancer, neuroendocrine cancer (any organ), gastric cancer, or lung cancer, can be treated with the Phase II protocol therapy; however, the patient will need to undergo selected medical tests to make sure this treatment would be safe for them.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 3, 2011

Status Verified

March 1, 2011

Enrollment Period

10.9 years

First QC Date

September 13, 2005

Last Update Submit

March 2, 2011

Conditions

Neuroendocrine CancerSmall Cell Lung CancerNon-Small Cell Lung CancerGastric Cancer

Keywords

thermochemotherapyfever range whole bodycisplatingemcitabinedaily low dose interferon alpha

Outcome Measures

Primary Outcomes (3)

  • Tumor Response by RECIST criteria (CR+PR)

    5 years

  • Response Duration

    5 years

  • Survival

    5 years

Secondary Outcomes (2)

  • Toxicity

    5 years

  • Quality of Life

    5 years

Study Arms (1)

1

OTHER

Thermochemotherapy

Other: thermochemotherapyDrug: Cisplatin, Gemcitabine, Interferon-a

Interventions

thermochemotherapyOTHER

cisplatin 60 mg/m2 i.v. over 4 hours on day 1 gemcitabine 600 mg/m2 i.v. over 60 minutes on day 3 interferon-alpha 1 million international units s.c. daily for protocol duration

Also known as: fever-range systemic thermal therapy
1
Cisplatin, Gemcitabine, Interferon-aDRUG

cisplatin 60 mg/m2 i.v. over 4 hours gemcitabine 600 mg/m2 i.v. over 1 hour interferon-alpha 100,000 i.u. s.c.daily fever-range whole-body thermal therapy to 40 oC (104 oF) for 6 hours duration

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Any patient with inoperable or metastatic small-cell lung cancer, neuroendocrine cancer (any organ), gastric cancer, of lung cancer are eligible for protocol treatment.
  • However the patient:
  • Must not have metastasis to the brain
  • Must be able to achieve positive results on preliminary tests
  • Must have a good ECOG performance status

You may not qualify if:

  • Metastasis to the brain
  • Poor results on preliminary physiological tests
  • a Poor ECOG performance status score

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, NeuroendocrineSmall Cell Lung CarcinomaCarcinoma, Non-Small-Cell LungStomach Neoplasms

Interventions

CisplatinGemcitabineInterferon-alpha

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological 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

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

Esperanza N Fernandez

CONTACT

713-500-6774Esperanza.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

July 1, 2002

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

March 3, 2011

Record last verified: 2011-03

Locations

US(1)