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

Paused · Phase 1

Conditions studied: Ovarian Cancer

In brief

To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.

Key facts

Study ID

NCT02093871

Run by

ThermalCore Inc

People needed

20

Starts

2013-08-01

Expected to finish

2018-06-01

Last updated by the study team

2017-07-21

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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