Recruiting
Phase 2

Thermo-Chemotherapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT00178698

Conditions

Neuroendocrine Cancer

Small Cell Lung Cancer

Non-Small Cell Lung Cancer

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

thermochemotherapy

Cisplatin, Gemcitabine, Interferon-a

thermochemotherapy

Study Details

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.

Conditions

Neuroendocrine Cancer

Small Cell Lung Cancer

Non-Small Cell Lung Cancer

Gastric Cancer

Study ID

NCT00178698

Start date

Jul, 2002

Status verified date

Mar, 2011

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

- 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

Exclusion Criteria:

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 1

Thermochemotherapy

Interventions

thermochemotherapy

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

Cisplatin, Gemcitabine, Interferon-a

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

thermochemotherapy

After hydration and anti-emetics, cisplatin 60 mg/m2 i.v. is given over 4 hours on day 1. Also on day 1, begin daily low-dose interferon-alpha 1 million international units s.c. On day 3, 36 hours after cisplatin infusion, induce fever-range whole-body thermal therapy to 40 oC (104 oF) for a duration of 6 hrs. When the target temperature of 40 oC is reached, gemcitabine 600 mg/m2 is administered i.v. over 60 minutes, and the temperature is maintained at plateau for a total of 6 hours. The cycle is repeated at 21 to 28 day intervals.

Primary outcome measure

  • Tumor Response by RECIST criteria (CR+PR) [ Time Frame: 5 years ]
  • Response Duration [ Time Frame: 5 years ]
  • Survival [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Joan M Bull, M.D.

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

Esperanza N Fernandez

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

Locations

Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Joan M Bull, M.D.

713-600-6820Joan.M.Bull@uth.tmc.edu

Esperanza N Fernandez

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

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

  • thermochemotherapy
  • fever range whole body
  • cisplatin
  • gemcitabine
  • daily low dose interferon alpha

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.