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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00178698 |
Thermal therapy/hyperthermia (heat) can increase cancer kill by chemotherapy treatments. By itself, thermal therapy can also kill cancer cells. 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 see 1) if it improves cancer response compared to the effect of only chemotherapy drugs in current use, 2) if the thermochemotherapy helps the person's own body fight the cancer cells, and 3) if this treatment is safe and comfortable for the patient. This study does not offer heat treatment alone. Any patient with inoperable or metastatic neuroendocrine cancer (any organ), gastric cancer, or lung cancer, including small cell 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.
Condition | Intervention | Phase |
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Neuroendocrine Cancer Small Cell Lung Cancer Non-Small Cell Lung Cancer Gastric Cancer |
Other: thermochemotherapy Drug: Cisplatin, Gemcitabine, Interferon-a |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A PHASE II CLINICAL TRIAL OF CISPLATIN + GEMCITABINE HCl (GEM) + LOW-DOSE METRONOMIC INTERFERON-a (IFN-a) COMBINED WITH FEVER-RANGE WHOLE-BODY THERMAL THERAPY (FR-WB-TT) IN PATIENTS WITH METASTATIC/OR LOCALLY ADVANCED MALIGNANCIES |
Estimated Enrollment: | 36 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Thermochemotherapy
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Other: 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
Drug: 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
Other: 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.
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Once accepted for this study, you will need to have a central venous line (CV line or port) inserted if you do not already have one. (The line placement may be done by your own doctor, or we will be happy to help you with this procedure).
The treatment cycle begins with 6 hours of intravenous (IV) hydration followed by an infusion of the anti-cancer drug, Cisplatin. In addition, at the beginning of this treatment, you will begin daily low-dose Interferon-alpha that will continue for the entire duration of your participation in this study. The daily low-dose Interferon-alpha, interrupts the division of cancer cells, kills blood vessels feeding the cancer, and slows tumor growth, and as well boosts the body's immunity against the cancer.
Thirty-six hours after the cisplatin infusion, you will be treated with fever-range thermal therapy (whole-body heat). The fever-range whole-body thermal therapy enhances the effect of chemotherapy drugs against the cancer, and is thought to also boost your own immune response against the cancer. When the core body temperature reaches 104oF (40oC), a 30-minute (IV) infusion of another chemotherapy drug, gemcitabine (Gemzar) is given. Cisplatin, low-dose interferon-alpha and gemcitabine are the only chemotherapy drugs used in this treatment protocol. No other chemotherapy drugs are allowed to be given under this treatment plan.
The fever-range whole-body heat treatment is performed while you are lightly sedated. With this type of sedation, you are awake during the treatment but you are not uncomfortable. This type of sedation method is used to reduce any discomfort of the 6-hour heat treatment procedure yet allows you to talk to the nurses.
Your body temperature is raised to 104oF (40oC) over a period of 60-120 minutes. When your body first reaches the target 104oF, we administer the gemcitabine chemotherapy over 60 minutes and continue to maintain the 104oF body temperature for six hours. At the conclusion of the six hours of thermochemotherapy, you will be cooled off to your normal body temperature, which takes about 30-45 minutes. The entire treatment lasts approximately 8 hours. After the treatment is completed, we will observe you for 2 to 12 hours to make sure you have tolerated the treatment.
You will continue the daily low-dose Interferon-alpha. Additionally, you will be given daily Leukine (sargramostim, GM-CSF) injections beginning 3-5 days after receiving chemotherapy to help support your immune system by helping your body create more white blood cells, which are important in helping your body fight infection.
After treatment, you will need a complete blood count with platelet and differential count each week. These lab studies can be done at your own doctor's office or hospital as long as you make sure that the results are faxed to us. They can also be done in our clinic. We will see you again in approximately three to four weeks and the treatment cycle will be repeated.
We always attempt to perform at least two thermo-chemotherapy cycles. After the second treatment, CT and/or MRI scans are repeated to see if your cancer is smaller. These scans, along with a physical examination and the lab studies, are used to determine if additional heat treatments will be performed. Additional treatments continue based on how well your response to the treatment. There is no limit to the number of heat treatments a patient may have.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Joan M Bull, M.D. | 713-500-6820 | Joan.M.Bull@uth.tmc.edu |
Contact: Esperanza N Fernandez | 713-500-6774 | Esperanza.N.Fernandez@uth.tmc.edu |
United States, Texas | |
Memorial Hermann Hospital | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Joan M Bull, M.D. 713-600-6820 Joan.M.Bull@uth.tmc.edu | |
Contact: Esperanza N Fernandez 713-500-6774 Esperanza.N.Fernandez@uth.tmc.edu | |
Principal Investigator: Joan M Bull, M.D. |
Principal Investigator: | Joan M Bull, M.D. | The University of Texas Health Science Center, Houston |
Responsible Party: | The University of Texas Health Science Center, Houston ( Joan M.C Bull, M.D. ) |
Study ID Numbers: | HSC-MS-04-259 |
Study First Received: | September 13, 2005 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00178698 |
Health Authority: | United States: Institutional Review Board |
thermochemotherapy fever range whole body cisplatin gemcitabine daily low dose interferon alpha |
Thoracic Neoplasms Carcinoma, Neuroendocrine Gastrointestinal Diseases Fever Stomach Diseases Cisplatin Respiratory Tract Diseases Lung Neoplasms Stomach Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasm Metastasis Neuroepithelioma Gemcitabine Interferon-alpha Non-small cell lung cancer |
Digestive System Neoplasms Interferons Stomach cancer Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Digestive System Diseases Lung Diseases Gastrointestinal Neoplasms Interferon Alfa-2a Adenocarcinoma Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue |
Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses |