A Phase 1 interventional study of ThermalCore Hyperthermia System in Ovarian Cancer, sponsored by ThermalCore Inc. Suspended at 1 site in United States. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by ThermalCore Inc · Phase 1, Interventional, and Treatment
To confirm the safety of 6 cycles of Perfusion Induced Systemic Hyperthermia (PISH) provided every 28 days in 3rd line ovarian cancer patients.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 726 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →This is the only study on the registry with ThermalCore Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Time frame: 28 days
Time To Progression of Disease
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.
Time frame: 8 months
Number of patients with unexpected serious adverse events
Determine the frequency and severity of unexpected serious adverse events
Time frame: 8 Months
This study is suspended, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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