Back to resultsA Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer (PISH-2)
Primary Purpose
Ovarian Cancer
Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ThermalCore Hyperthermia System
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring Ovarian cancer, Therapeutic hyperthermia, HEATT, whole body hyperthermia, hyperthermia, PISH, Verthermia, Phase 1 clinical trial, stage 3 ovarian cancer, stage 4 ovarian cancer, stage III ovarian cancer, stage IV ovarian cancer, late stage ovarian cancer, Core HFC, Lilja, Vertrees, Bastidas, total body hyperthermia
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Patients with ovarian cancer/primary peritoneal cancer of any histologic subtype, including epithelial, germ cell, sex-cord stromal, or sarcoma.
- Failure of first line surgery and chemotherapy, AND at least second line chemotherapy, with or without secondary cytoreductive surgeries
- Patients must be eligible for, and be expecting treatment by, an FDA approved chemotherapy regimen commonly used for their disease as per community standard.
- Female patients, aged 18-69 years old, and must be aware of the investigational nature of this treatment, and then indicate informed consent by the IRB-approved written process.
- All patients must have a performance status (Karnofsky score) greater than 80
- Patients may have been treated with radiotherapy, or non-chemotherapy anti-neoplastics (e.g. anti-angiogenic agents like bevicizumab)
- Hematologic Parameters: WBC of > 4,000/μl with an ANC >1500/μl, and a Platelet count of >100,000/μl
- Renal Filtration: pretreatment measured or calculated creatinine clearance of > 50 ml/minute by Cockroft-Gault equation or MDRD
- Electrolytes parameters: Patients pre-treatment serum calcium be in the normal (8.5-10.5 mg/dL) range.
- Liver function parameters: Bilirubin ≤ 1.5 times upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; PT/INR ≤ 1.5 times ULN (or an in-range INR, usually between 2 and 3, if the patient is on a stable dose of therapeutic warfarin)
Exclusion Criteria:
- Patients who would be expected to receive benefit, on third recurrence, by a platinum-based regimen of chemotherapy
- Uncontrolled hypertension, defined as systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg
- Myocardial infarction or unstable angina within the past 6 months
- NYHA class II-IV congestive heart failure
- Atrial fibrillation (AF) or Supra Ventricular Tachycardia (SVT) whether controlled by drugs or not; Any other serious arrhythmia, requiring medication to control
- Currently on anticoagulation for DVT or PE.
- Peripheral vascular disease ≥ CTCAE grade 2 (at least brief [< 24 hrs] episodes of ischemia managed non-surgically and without permanent deficit)
- CNS metastases
- Lung disease, and a pulmonary function test (PFT) with FEV1 <50% expected.
- Patients who have been treated with any chemotherapy or biologic therapy within the previous 21 days.
- Subjects who are unable or unwilling to comply with the follow-up schedule and requirements or sign informed consent
Sites / Locations
- Good Samaritan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ThermalCore Hyperthermia System
Arm Description
Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days
Outcomes
Primary Outcome Measures
Organ toxicity
Patients continue to meet the entry criteria for organ toxicity defined in the trial by the time prior to next scheduled treatment at 28 days.
Secondary Outcome Measures
Time To Progression of Disease
Time To Progression (TTP, defined as the interval from treatment initiation to disease progression) for the cohort. Measurement of Time To Progression (TTP) for the cohort will be conducted using PET CT, CA-125, and physical examination. Progression is defined as radiologic progression RECIST criteria, CA-125 doubling per Gynecologic Intergroup Definition of progression of disease, or any evidence of palpable lesion growth on physical examination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02093871
Brief Title
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer
Acronym
PISH-2
Official Title
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Suspended
Study Start Date
August 2013 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ThermalCore Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.
Detailed Description
This study is a prospective, single-arm phase I trial of 20 ovarian cancer patients to be treated with PISH for 6 cycles, delivered every 28 days. This mimics chemotherapy treatments, in concordance with the fractional cell kill hypothesis of cytotoxic agents.
As this study is for safety, only, metastatic peritoneal or ovarian cancer, of any histology (epithelial, sex-cord stromal, germ cell, or sarcoma) that has progressed after 2 cycles of chemotherapy, and is considered incurable, will be included. All patients must meet performance status and organ function entry criteria. Patients must have first undergone standard first line primary surgery and chemotherapy, and have then gone on to fail second line chemotherapy treatment, (with or without secondary cytoreductive surgeries). Patients must be candidates for, and expecting treatment by, the usual third line chemotherapy agent palliation traditionally offered by medical oncology. Patients may have received treatment beyond third-line therapy, as long as they meet entry requirements for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian cancer, Therapeutic hyperthermia, HEATT, whole body hyperthermia, hyperthermia, PISH, Verthermia, Phase 1 clinical trial, stage 3 ovarian cancer, stage 4 ovarian cancer, stage III ovarian cancer, stage IV ovarian cancer, late stage ovarian cancer, Core HFC, Lilja, Vertrees, Bastidas, total body hyperthermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ThermalCore Hyperthermia System
Arm Type
Experimental
Arm Description
Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days
Intervention Type
Device
Intervention Name(s)
ThermalCore Hyperthermia System
Intervention Description
Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days
Primary Outcome Measure Information:
Title
Organ toxicity
Description
Patients continue to meet the entry criteria for organ toxicity defined in the trial by the time prior to next scheduled treatment at 28 days.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Time To Progression of Disease
Description
Time To Progression (TTP, defined as the interval from treatment initiation to disease progression) for the cohort. Measurement of Time To Progression (TTP) for the cohort will be conducted using PET CT, CA-125, and physical examination. Progression is defined as radiologic progression RECIST criteria, CA-125 doubling per Gynecologic Intergroup Definition of progression of disease, or any evidence of palpable lesion growth on physical examination.
Time Frame
8 months
Other Pre-specified Outcome Measures:
Title
Number of patients with unexpected serious adverse events
Description
Determine the frequency and severity of unexpected serious adverse events
Time Frame
8 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Patients with ovarian cancer/primary peritoneal cancer of any histologic subtype, including epithelial, germ cell, sex-cord stromal, or sarcoma.
Failure of first line surgery and chemotherapy, AND at least second line chemotherapy, with or without secondary cytoreductive surgeries
Patients must be eligible for, and be expecting treatment by, an FDA approved chemotherapy regimen commonly used for their disease as per community standard.
Female patients, aged 18-69 years old, and must be aware of the investigational nature of this treatment, and then indicate informed consent by the IRB-approved written process.
All patients must have a performance status (Karnofsky score) greater than 80
Patients may have been treated with radiotherapy, or non-chemotherapy anti-neoplastics (e.g. anti-angiogenic agents like bevicizumab)
Hematologic Parameters: WBC of > 4,000/μl with an ANC >1500/μl, and a Platelet count of >100,000/μl
Renal Filtration: pretreatment measured or calculated creatinine clearance of > 50 ml/minute by Cockroft-Gault equation or MDRD
Electrolytes parameters: Patients pre-treatment serum calcium be in the normal (8.5-10.5 mg/dL) range.
Liver function parameters: Bilirubin ≤ 1.5 times upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; PT/INR ≤ 1.5 times ULN (or an in-range INR, usually between 2 and 3, if the patient is on a stable dose of therapeutic warfarin)
Exclusion Criteria:
Patients who would be expected to receive benefit, on third recurrence, by a platinum-based regimen of chemotherapy
Uncontrolled hypertension, defined as systolic BP > 160 mm Hg or diastolic BP > 100 mm Hg
Myocardial infarction or unstable angina within the past 6 months
NYHA class II-IV congestive heart failure
Atrial fibrillation (AF) or Supra Ventricular Tachycardia (SVT) whether controlled by drugs or not; Any other serious arrhythmia, requiring medication to control
Currently on anticoagulation for DVT or PE.
Peripheral vascular disease ≥ CTCAE grade 2 (at least brief [< 24 hrs] episodes of ischemia managed non-surgically and without permanent deficit)
CNS metastases
Lung disease, and a pulmonary function test (PFT) with FEV1 <50% expected.
Patients who have been treated with any chemotherapy or biologic therapy within the previous 21 days.
Subjects who are unable or unwilling to comply with the follow-up schedule and requirements or sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Winetz, MD
Organizational Affiliation
ThermalCore Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95124
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer
We'll reach out to this number within 24 hrs