Clinical trial · Interventional
A Phase 1 Trial of Perfusion Induced Systemic Hyperthermia (PISH) Over Multiple Cycles for Terminal Ovarian Cancer
NCT02093871CI-TRIAL-00028736PISH-2suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ThermalCore Hyperthermia System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ThermalCore Hyperthermia System
- description
- Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days
- interventionNames
- Device: ThermalCore Hyperthermia System
Primary outcomes (1)
- measure
- Organ toxicity
- timeFrame
- 28 days
- 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.
Secondary outcomes (1)
- measure
- Time To Progression of Disease
- timeFrame
- 8 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.