Recurrent Malignant Solid Neoplasm, Stage IV Bladder Cancer, Stage IV Breast Cancer, Stage IV Colon Cancer, Stage IV Colorectal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Gastric Cancer, Stage IV Liver Cancer, Stage IV Lung Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Cancer, Stage IV Pancreatic Cancer, Stage IV Prostate Cancer, Stage IV Rectal Cancer, Stage IV Renal Cell Cancer, Stage IV Small Intestinal Cancer
Conditions
Brief summary
The study designed is to evaluate the safety of Canady Helios™ Cold Plasma Scalpel (CHCPS) in patients with solid tumors with carcinomatosis scheduled to undergo surgical resection for cytoreduction. Patients with stage 4 resectable tumors as decided by a multidisciplinary disease management team may be included if the metastatic disease is non-synchronous (e.g. recurrent colorectal carcinoma with hepatic metastasis amenable for surgical resection).. Plasma is an ionized gas typically generated in high-temperature laboratory conditions. Plasma coagulators are currently used routinely as surgical tools with multiple applications that create temperatures between 37° C to 43°C and cause thermal injury. Earlier studies demonstrated the non-aggressive nature of cold plasma. As evidence accumulates, it is becoming clear that low-temperature cold plasma has an increasing role in biomedical applications.
Interventions
DEVICECanady Helios Cold Plasma Scalpel
Device used to distribute cold plasma energy at the resected tumor margins.
Sponsors
Jerome Canady, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Solid tumors undergoing surgical treatment with carcinomatosis scheduled to undergo surgical resection for cytoreduction. Patients with stage 4 resectable tumors as decided by a multidisciplinary disease management team may be included if the metastatic disease is non-synchronous (e.g. recurrent colorectal carcinoma with hepatic metastasis amenable for surgical resection). * 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 Good Clinical Practice (GCP) guidelines and institutional policy. * Biopsy (histopathology or cytology) diagnosis of a solid tumor as defined by the World Health Organization (WHO) or by cross-sectional imaging reviewed by a board-certified radiologist. * Good performance status (ECOG \< 2), Karnofsky \>60%, * Patients with low or acceptable surgical risk (American society of Anesthesiology (ASA) score of 3 or less. * Patient 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 ≤ 3.0 mg/dl ; alkaline phosphatase \< 2.5 times the upper limit of normal; and, aspartate aminotransferase (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, blood urea nitrogen (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
Exclusion criteria
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 Karnofsky \< 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 \> 3.0 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complications Due To Cold Plasma Application | Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations. | Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary Arm After the gross solid tumor is removed, cold plasma is sprayed in the area of the resected tumor margins.
Canady Helios Cold Plasma Scalpel: Device used to distribute cold plasma energy at the resected tumor margins.
Post-operatively, patients will be started back on Adjuvant chemotherapy, radiation, or immuno-therapy as per medical oncology and multi-disciplinary team. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Primary Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 59 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment Israel | 5 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
| Tumor Type Metastatic Angiosarcoma of the right breast to the contralateral left breast and axilla | 1 Participants |
| Tumor Type Metastatic Cholangiocarcinoma to the left elbow/distal humerus | 1 Participants |
| Tumor Type Metastatic Desmoplastic Small Round Cell Sarcoma (DSRCS) of left inguinal lymph node and testicle | 1 Participants |
| Tumor Type Metastatic Non-Small Cell Lung Carcinoma (NSCLC) to right hip | 1 Participants |
| Tumor Type Metastatic Pleomorphic Sarcoma to the left distal femur | 1 Participants |
| Tumor Type Metastatic Pleomorphic Spindle Cell Sarcoma to the humerus | 1 Participants |
| Tumor Type Metastatic Recurrent Adenoid Cystic Carcinoma of the neck | 1 Participants |
| Tumor Type Metastatic Recurrent Anal Squamous Carcinoma to the Liver (HPV Related) | 1 Participants |
| Tumor Type Metastatic Recurrent Breast Carcinoma to the right hip | 1 Participants |
| Tumor Type Metastatic Recurrent Chordoma to the right gluteal posterior thigh | 1 Participants |
| Tumor Type Metastatic Recurrent Colon Cancer | 1 Participants |
| Tumor Type Metastatic Recurrent Colon Cancer to the retroperitoneum | 1 Participants |
| Tumor Type Metastatic Recurrent Melanoma to the left pelvis | 1 Participants |
| Tumor Type Metastatic Recurrent Mesothelioma to the abdominal wall | 1 Participants |
| Tumor Type Metastatic Recurrent Myxofibrosarcoma to the chest wall | 1 Participants |
| Tumor Type Metastatic Recurrent Non-Small cell lung Adenocarcinoma to the left/hip/upper end of femur | 1 Participants |
| Tumor Type Metastatic Recurrent Non-Small Cell Lung Carcinoma (NSCLC) to the left hemipelvis | 1 Participants |
| Tumor Type Metastatic Recurrent Ovarian Cancer | 1 Participants |
| Tumor Type Metastatic Recurrent Squamous Cell Carcinoma to the left hand and left axillary lymph node | 1 Participants |
| Tumor Type Metastatic Renal Cell Carcinoma to the left clavicle | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With Complications Due To Cold Plasma Application
Adverse events (CTCAE event version 4.03 to 5.0) within 30 days after Canady Helios Cold Plasma Scalpel treatment.
Time frame: Immediate after application of cold plasma, followed by 3 months, 6 months, 12 months and 15 month observations.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Arm | Number of Participants With Complications Due To Cold Plasma Application | Number of participants with complications secondary to cold plasma application | 0 Participants |
| Primary Arm | Number of Participants With Complications Due To Cold Plasma Application | Number of patients receiving cold plasma application. | 20 Participants |