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

July 19, 2017 updated by: ThermalCore Inc
To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95124
        • Good Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with unexpected serious adverse events
Time Frame: 8 Months
Determine the frequency and severity of unexpected serious adverse events
8 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ThermalCore Inc

Investigators

  • Principal Investigator: Jan Winetz, MD, ThermalCore Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

March 20, 2014

First Posted (Estimate)

March 21, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thermalcore-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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