Nanotechnology in Cancer Research: A Phase 1 Clinical Trial of TNF-Bound Colloidal Gold

2.50
Hdl Handle:
http://hdl.handle.net/10755/164838
Category:
Abstract
Type:
Presentation
Title:
Nanotechnology in Cancer Research: A Phase 1 Clinical Trial of TNF-Bound Colloidal Gold
Author(s):
Walker, Melissa; Seidel, Geoff; Tamarkim, Lawrence; Paciotti, Giulio; Haynes, Ryan
Author Details:
Melissa Walker, RN
Abstract:
Research Study: The emergence of targeted therapy using nanotechnology has made its way into clinical trials. The goal of using nanotechnology in cancer treatment is to target malignant cells, while preserving healthy cells, virtually eliminating toxicities while maximizing anti-tumor effects. In the 1980's Tumor Necrosis Factor (TNF) was given to patients; however Dose Limiting Toxicities (DLT) such as hypotension and death were noted. In the 1990Æs, research using TNF was revived for Isolated Limb Perfusion. Recently the concept of having a 'drug delivery' system to deliver the TNF to the targeted tumor tissue has been studied. In pre-clinical testing, TNF-bound colloidal gold trafficked preferentially to tumor tissue while demonstrating anti-tumor effects. This abstract highlights testing of TNF-bound colloidal gold (CYT-6091) in humans. The primary objective of the Phase 1 clinical trial was to evaluate the maximum tolerated dose (MTD) of CYT-6091 in patients with advanced solid organ malignancies. Secondary objectives included: evaluating disease response, and trafficking of gold nanoparticles to tumor tissue. Traditional Phase 1 study design was used: dose escalation with doses ranging from 50-600mcg/m2. The patients were dosed on day 0 and 14. Adverse events were monitored throughout the trial. Blood was drawn for pharmacokinetic studies, chemistry panels, and blood counts at specified time intervals. Biopsies were taken from tumor and healthy tissue 24 hours after the first injection of CYT-6091 for evaluation of gold content using Electron Microscopy. Twenty-nine patients, (eleven males, eighteen females) were dosed with CYT-6091. During the trial, no DLT occurred indicating that TNF-bound colloidal gold is tolerated at doses 3-times greater than TNF. Most common adverse events included: lymphopenia and electrolyte imbalances. All adverse events were reversible within several days. Twenty-eight patients were evaluated for a response using the Response Evaluation Criteria for Solid Tumors (RECIST). One patient had a partial response and three patients had stable disease. Gold nanoparticles were present in greater quantities in tumor tissue confirming the affinity to tumor tissue. The breakthrough of nanotechnology will revolutionize cancer therapies. It is vital nurses understand how this cutting-edge technology will directly impact Oncology patients.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2009
Conference Name:
34th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
San Antonio, Texas, USA
Sponsors:
Funding Source: CytImmune Sciences Incorporated.
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleNanotechnology in Cancer Research: A Phase 1 Clinical Trial of TNF-Bound Colloidal Golden_GB
dc.contributor.authorWalker, Melissaen_US
dc.contributor.authorSeidel, Geoffen_US
dc.contributor.authorTamarkim, Lawrenceen_US
dc.contributor.authorPaciotti, Giulioen_US
dc.contributor.authorHaynes, Ryanen_US
dc.author.detailsMelissa Walker, RNen_US
dc.identifier.urihttp://hdl.handle.net/10755/164838-
dc.description.abstractResearch Study: The emergence of targeted therapy using nanotechnology has made its way into clinical trials. The goal of using nanotechnology in cancer treatment is to target malignant cells, while preserving healthy cells, virtually eliminating toxicities while maximizing anti-tumor effects. In the 1980's Tumor Necrosis Factor (TNF) was given to patients; however Dose Limiting Toxicities (DLT) such as hypotension and death were noted. In the 1990Æs, research using TNF was revived for Isolated Limb Perfusion. Recently the concept of having a 'drug delivery' system to deliver the TNF to the targeted tumor tissue has been studied. In pre-clinical testing, TNF-bound colloidal gold trafficked preferentially to tumor tissue while demonstrating anti-tumor effects. This abstract highlights testing of TNF-bound colloidal gold (CYT-6091) in humans. The primary objective of the Phase 1 clinical trial was to evaluate the maximum tolerated dose (MTD) of CYT-6091 in patients with advanced solid organ malignancies. Secondary objectives included: evaluating disease response, and trafficking of gold nanoparticles to tumor tissue. Traditional Phase 1 study design was used: dose escalation with doses ranging from 50-600mcg/m2. The patients were dosed on day 0 and 14. Adverse events were monitored throughout the trial. Blood was drawn for pharmacokinetic studies, chemistry panels, and blood counts at specified time intervals. Biopsies were taken from tumor and healthy tissue 24 hours after the first injection of CYT-6091 for evaluation of gold content using Electron Microscopy. Twenty-nine patients, (eleven males, eighteen females) were dosed with CYT-6091. During the trial, no DLT occurred indicating that TNF-bound colloidal gold is tolerated at doses 3-times greater than TNF. Most common adverse events included: lymphopenia and electrolyte imbalances. All adverse events were reversible within several days. Twenty-eight patients were evaluated for a response using the Response Evaluation Criteria for Solid Tumors (RECIST). One patient had a partial response and three patients had stable disease. Gold nanoparticles were present in greater quantities in tumor tissue confirming the affinity to tumor tissue. The breakthrough of nanotechnology will revolutionize cancer therapies. It is vital nurses understand how this cutting-edge technology will directly impact Oncology patients.en_GB
dc.date.available2011-10-27T12:07:55Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:07:55Z-
dc.conference.date2009en_US
dc.conference.name34th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationSan Antonio, Texas, USAen_US
dc.description.sponsorshipFunding Source: CytImmune Sciences Incorporated.-
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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