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

NCT02093871 | Suspended Phase 1 DMC

• 1 other identifier: Thermalcore-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (1)

• Time To Progression of Disease

  8 months

Other Outcomes (1)

• Number of patients with unexpected serious adverse events

  8 Months

Study Arms (1)

ThermalCore Hyperthermia System

EXPERIMENTAL

Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days

Device: ThermalCore Hyperthermia System

Interventions

ThermalCore Hyperthermia System DEVICE

Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days

ThermalCore Hyperthermia System

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ThermalCore Inc: lead

Study Sites (1)

Good Samaritan Hospital

San Jose, California, 95124, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Hyperthermia

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Jan Winetz, MD

  ThermalCore Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: March 21, 2014
• Study Start: August 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

US (1)