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A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer (PISH-2)

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02093871
First Posted: March 21, 2014
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ThermalCore Inc
  Purpose
To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.

Condition Intervention Phase
Ovarian Cancer Device: ThermalCore Hyperthermia System Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by ThermalCore Inc:

Primary Outcome Measures:
  • Organ toxicity [ Time Frame: 28 days ]
    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 Frame: 8 months ]
    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.


Other Outcome Measures:
  • Number of patients with unexpected serious adverse events [ Time Frame: 8 Months ]
    Determine the frequency and severity of unexpected serious adverse events


Estimated Enrollment: 20
Study Start Date: August 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ThermalCore Hyperthermia System
Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days
Device: ThermalCore Hyperthermia System
Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02093871


Locations
United States, California
Good Samaritan Hospital
San Jose, California, United States, 95124
Sponsors and Collaborators
ThermalCore Inc
Investigators
Principal Investigator: Jan Winetz, MD ThermalCore Inc
  More Information

Responsible Party: ThermalCore Inc
ClinicalTrials.gov Identifier: NCT02093871     History of Changes
Other Study ID Numbers: Thermalcore-01
First Submitted: August 14, 2013
First Posted: March 21, 2014
Last Update Posted: July 21, 2017
Last Verified: July 2017

Keywords provided by ThermalCore Inc:
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Fever
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Body Temperature Changes
Signs and Symptoms