The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer
Local regional recurrence (LRR) remains the primary cause of treatment failure in solid tumors despite advancements in cancer therapies. Canady Helios Cold Plasma (CHCP) is a novel Cold Atmospheric Plasma device that generates an Electromagnetic Field and Reactive Oxygen and Nitrogen Species to indu...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-07-01
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| Series: | Cancers |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2072-6694/15/14/3688 |
| _version_ | 1797589894508314624 |
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| author | Jerome Canady Saravana R. K. Murthy Taisen Zhuang Steven Gitelis Aviram Nissan Lawan Ly Olivia Z. Jones Xiaoqian Cheng Mohammad Adileh Alan T. Blank Matthew W. Colman Keith Millikan Cristina O’Donoghue Kerstin M. Stenson Karen Ohara Gal Schtrechman Michael Keidar Giacomo Basadonna |
| author_facet | Jerome Canady Saravana R. K. Murthy Taisen Zhuang Steven Gitelis Aviram Nissan Lawan Ly Olivia Z. Jones Xiaoqian Cheng Mohammad Adileh Alan T. Blank Matthew W. Colman Keith Millikan Cristina O’Donoghue Kerstin M. Stenson Karen Ohara Gal Schtrechman Michael Keidar Giacomo Basadonna |
| author_sort | Jerome Canady |
| collection | DOAJ |
| description | Local regional recurrence (LRR) remains the primary cause of treatment failure in solid tumors despite advancements in cancer therapies. Canady Helios Cold Plasma (CHCP) is a novel Cold Atmospheric Plasma device that generates an Electromagnetic Field and Reactive Oxygen and Nitrogen Species to induce cancer cell death. In the first FDA-approved Phase I trial (March 2020–April 2021), 20 patients with stage IV or recurrent solid tumors underwent surgical resection combined with intra-operative CHCP treatment. Safety was the primary endpoint; secondary endpoints were non-LRR, survival, cancer cell death, and the preservation of surrounding healthy tissue. CHCP did not impact intraoperative physiological data (<i>p</i> > 0.05) or cause any related adverse events. Overall response rates at 26 months for R0 and R0 with microscopic positive margin (R0-MPM) patients were 69% (95% CI, 19–40%) and 100% (95% CI, 100–100.0%), respectively. Survival rates for R0 (n = 7), R0-MPM (n = 5), R1 (n = 6), and R2 (n = 2) patients at 28 months were 86%, 40%, 67%, and 0%, respectively. The cumulative overall survival rate was 24% at 31 months (n = 20, 95% CI, 5.3–100.0). CHCP treatment combined with surgery is safe, selective towards cancer, and demonstrates exceptional LRR control in R0 and R0-MPM patients. (Clinical Trials identifier: NCT04267575). |
| first_indexed | 2024-03-11T01:12:37Z |
| format | Article |
| id | doaj.art-628e24fdd1fc48669c9a77d9afe81778 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-11T01:12:37Z |
| publishDate | 2023-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-628e24fdd1fc48669c9a77d9afe817782023-11-18T18:42:43ZengMDPI AGCancers2072-66942023-07-011514368810.3390/cancers15143688The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for CancerJerome Canady0Saravana R. K. Murthy1Taisen Zhuang2Steven Gitelis3Aviram Nissan4Lawan Ly5Olivia Z. Jones6Xiaoqian Cheng7Mohammad Adileh8Alan T. Blank9Matthew W. Colman10Keith Millikan11Cristina O’Donoghue12Kerstin M. Stenson13Karen Ohara14Gal Schtrechman15Michael Keidar16Giacomo Basadonna17Department of Translational Research, Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Takoma Park, MD 20912, USADepartment of Translational Research, Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Takoma Park, MD 20912, USADepartment of Translational Research, Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Takoma Park, MD 20912, USADepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgical Oncology/General Surgery, Chaim Sheba Medical Center, Ramat Gan 52621, IsraelDepartment of Translational Research, Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Takoma Park, MD 20912, USADepartment of Translational Research, Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Takoma Park, MD 20912, USADepartment of Translational Research, Jerome Canady Research Institute for Advanced Biological and Technological Sciences, Takoma Park, MD 20912, USADepartment of Surgical Oncology/General Surgery, Chaim Sheba Medical Center, Ramat Gan 52621, IsraelDepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USADepartment of Surgical Oncology/General Surgery, Chaim Sheba Medical Center, Ramat Gan 52621, IsraelDepartment of Mechanical and Aerospace Engineering, The George Washington University, Washington, DC 20052, USADepartment of Surgery, University of Massachusetts Chan Medical School, Worcester, MA 01854, USALocal regional recurrence (LRR) remains the primary cause of treatment failure in solid tumors despite advancements in cancer therapies. Canady Helios Cold Plasma (CHCP) is a novel Cold Atmospheric Plasma device that generates an Electromagnetic Field and Reactive Oxygen and Nitrogen Species to induce cancer cell death. In the first FDA-approved Phase I trial (March 2020–April 2021), 20 patients with stage IV or recurrent solid tumors underwent surgical resection combined with intra-operative CHCP treatment. Safety was the primary endpoint; secondary endpoints were non-LRR, survival, cancer cell death, and the preservation of surrounding healthy tissue. CHCP did not impact intraoperative physiological data (<i>p</i> > 0.05) or cause any related adverse events. Overall response rates at 26 months for R0 and R0 with microscopic positive margin (R0-MPM) patients were 69% (95% CI, 19–40%) and 100% (95% CI, 100–100.0%), respectively. Survival rates for R0 (n = 7), R0-MPM (n = 5), R1 (n = 6), and R2 (n = 2) patients at 28 months were 86%, 40%, 67%, and 0%, respectively. The cumulative overall survival rate was 24% at 31 months (n = 20, 95% CI, 5.3–100.0). CHCP treatment combined with surgery is safe, selective towards cancer, and demonstrates exceptional LRR control in R0 and R0-MPM patients. (Clinical Trials identifier: NCT04267575).https://www.mdpi.com/2072-6694/15/14/3688cancer treatmentsurgical margin treatmentlocal regional recurrencecold atmospheric plasmasolid tumorsbreast cancer |
| spellingShingle | Jerome Canady Saravana R. K. Murthy Taisen Zhuang Steven Gitelis Aviram Nissan Lawan Ly Olivia Z. Jones Xiaoqian Cheng Mohammad Adileh Alan T. Blank Matthew W. Colman Keith Millikan Cristina O’Donoghue Kerstin M. Stenson Karen Ohara Gal Schtrechman Michael Keidar Giacomo Basadonna The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer Cancers cancer treatment surgical margin treatment local regional recurrence cold atmospheric plasma solid tumors breast cancer |
| title | The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer |
| title_full | The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer |
| title_fullStr | The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer |
| title_full_unstemmed | The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer |
| title_short | The First Cold Atmospheric Plasma Phase I Clinical Trial for the Treatment of Advanced Solid Tumors: A Novel Treatment Arm for Cancer |
| title_sort | first cold atmospheric plasma phase i clinical trial for the treatment of advanced solid tumors a novel treatment arm for cancer |
| topic | cancer treatment surgical margin treatment local regional recurrence cold atmospheric plasma solid tumors breast cancer |
| url | https://www.mdpi.com/2072-6694/15/14/3688 |
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