Clinical Trial using Canady Helios™ Cold Plasma Therapy for Solid Tumors
Used during surgery, Canady Helios™ Cold Plasma Therapy selectively targets cancer cells without damaging surrounding healthy tissue.
Canady Cold Atmospheric Plasma is used ‘intraoperatively’ with the standard protocol for cancer treatment including radiation and chemotherapy.
If you would like information on this Clinical Trial using Canady Helios™ Cold Plasma Therapy for Solid Tumors, please fill out and submit the form below.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study and must be willing to return for follow-up
18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with GCP guidelines and institutional policy.
Biopsy (histopathology or cytology) diagnosis of a solid tumor as defined by the WHO or by cross-sectional imaging reviewed by a board-certified radiologist.
Good performance status ( ECOG < 2), Karnofski >60%,
Patients with low or acceptable surgical risk (American society of Anesthesiology (ASA) score of 3 or less.
Patients is a candidate for surgical therapy as discussed and recommended by the institutional disease management team (DMT, Tumor Board).
At the time of enrollment:
Absolute neutrophil count (ANC) exceeds 1200/mm3, white blood cell count exceeds 4000/mm3 and platelet count is greater than 100,000/mm3
An international normalized ratio (INR) ≤ 1.5 (patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment can be withheld for operation will be eligible).
Adequate hepatic function must be met as evidenced by total serum bilirubin ≤ 1.5 mg/dl (patients with total bilirubin > 1.5 mg/dL eligible only with Gilbert’s syndrome); alkaline phosphatase < 2.5 times the upper limit of normal; and, AST less than 1.5 times upper limit of normal [alkaline phosphatase and AST cannot both exceed the upper limit of normal]
Serum renal functional parameters, BUN and creatinine are within normal limits
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Life expectancy of at least six months
An individual who meets any of the following criteria will be excluded from participation in this study:
Patients with unresectable tumors as decided by a multidisciplinary disease management team
Patients with multiple metastatic sites not amenable for surgical resection
Pregnancy or lactation
Patients with low performance status (ECOG > 2 or Karnofski < 60%)
Any one or more of the following hematological abnormalities
Hgb < 8gm/dl unable to be corrected with transfusion
Absolute Neutrophil Count < 1200/mm3
White blood cell count < 4000/mm3
Platelet count < 100,000/mm3
INR > 1.5 (except in patients who are therapeutically AST anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic treatment cannot be withheld for operation will be eligible)
History of hepatic cirrhosis or present hepatic dysfunction
Alkaline phosphatase ≥ 2.5 times the upper limit of normal
≥ 1.5 times upper limit of normal
Serum bilirubin > 1.5 mg/dl (except for patients with Gilbert’s syndrome who must have direct bilirubin ≤ 1.0 mg/dl)
Alkaline phosphatase and AST both exceed the upper limit of normal
Renal insufficiency indicated by a serum creatinine >1.5mg/dL.
Patients with high surgical risk (ASA 4-5) with significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease.
Febrile illness within 7 days before scheduled surgery
Treatment with another investigational drug or other intervention within 60 days before surgery
Patients that are unable to- or unwilling to provide a written informed consent
Patients who underwent treatment with cold plasma within a year before study entry.