Hyperthermia/Thermal Therapy With Chemotherapy to Treat Inoperable or Metastatic Tumors (FR-WB-TT/che)
Primary Purpose
Neuroendocrine Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
thermochemotherapy
Cisplatin, Gemcitabine, Interferon-a
thermochemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neuroendocrine Cancer focused on measuring thermochemotherapy, fever range whole body, cisplatin, gemcitabine, daily low dose interferon alpha
Eligibility Criteria
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
Sites / Locations
- Memorial Hermann HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Thermochemotherapy
Outcomes
Primary Outcome Measures
Tumor Response by RECIST criteria (CR+PR)
Response Duration
Survival
Secondary Outcome Measures
Toxicity
Quality of Life
Full Information
NCT ID
NCT00178698
First Posted
September 13, 2005
Last Updated
March 2, 2011
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT00178698
Brief Title
Hyperthermia/Thermal Therapy With Chemotherapy to Treat Inoperable or Metastatic Tumors
Acronym
FR-WB-TT/che
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 (Small-Cell Lung Cancer, Neuroendocrine Cancer, Gastric Cancer)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2002 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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 low-dose Interferon-alpha that will continue for the entire duration of your participation in this study. The 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 hyperthermia). 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 and can talk 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 low-dose Interferon-alpha injections once weekly. Additionally, you will be given 5-10 days of 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Cancer, Small Cell Lung Cancer, Non-Small Cell Lung Cancer, Gastric Cancer
Keywords
thermochemotherapy, fever range whole body, cisplatin, gemcitabine, daily low dose interferon alpha
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Thermochemotherapy
Intervention Type
Other
Intervention Name(s)
thermochemotherapy
Other Intervention Name(s)
fever-range systemic thermal therapy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Cisplatin, Gemcitabine, Interferon-a
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
thermochemotherapy
Intervention Description
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 Information:
Title
Tumor Response by RECIST criteria (CR+PR)
Time Frame
5 years
Title
Response Duration
Time Frame
5 years
Title
Survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
5 years
Title
Quality of Life
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joan M Bull, M.D.
Phone
713-500-6820
Email
Joan.M.Bull@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Esperanza N Fernandez
Phone
713-500-6774
Email
Esperanza.N.Fernandez@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan M Bull, M.D.
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan M Bull, M.D.
Phone
713-600-6820
Email
Joan.M.Bull@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Esperanza N Fernandez
Phone
713-500-6774
Email
Esperanza.N.Fernandez@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Joan M Bull, M.D.
12. IPD Sharing Statement
Learn more about this trial
Hyperthermia/Thermal Therapy With Chemotherapy to Treat Inoperable or Metastatic Tumors
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