Welcome!

News Feed Item

A new trial tests a combination of Vitamin C and "core" low dose, chemotherapy to reproduce promising safety and efficacy findings

NEW YORK, Aug. 21, 2014 /PRNewswire/ -- Bruckner Oncology has initiated an FDA approved Phase II-III clinical trial which adds Vitamin C to chemotherapy "core" regimens (GFLIO and GFLIO-D)  for patients with locally advanced and metastatic pancreatic cancer (APC).

Vitamin C was selected for study because there has never been a formal clinical trial of this frequently used, off label vitamin which has long been credited with improving safety and quality of life during chemotherapy. Also, many investigators found Vitamin C improved the effectiveness of specific chemotherapy for specific (not all) tumors under laboratory conditions. A successful test could benefit the nearly 50% of patients with APC and other cancers who now go untreated or undertreated because of safety and efficacy concerns.

SAFETY: The trial will attempt to reproduce the practice's pilot trial in which Vitamin C and the concurrent cores produced a less than one percent rate of clinically significant adverse events. The pilot group had many high risk patients. During Vitamin C co-treatment patients with preexisting symptoms and adverse events safely tolerated treatment and many improved. Standard treatments produce 10%-40% rates of clinically significant severe adverse events, in trials limited to ideal low risk patients.

SURVIVAL: The trial's secondary objective is to reproduce ten years of APC development experience with the cores. Median survival for prior patients with advanced pancreatic cancer including high risk patients, was 16 - 24 months (ASCO 2008, 2012, and 2013), high risk patients, often untreated elsewhere, are eligible for safe treatment with cores including the elderly, the prior treated and those with a poor 2-3 performance status (ASCO 2008). Current standard regimens in trials limited to ideal low risk patients produce MSTs of less than 12 months.

The core regimens were selected as the control because past experience suggests they may provide one of the safest treatment strategies for important anti-cancer drug classes.  There are potential lessons applicable to other cancers because the cores also appear to improve the performance of these drugs for other gastrointestinal, ovarian and uterine cancers (ASCO 2006, 2012, AACR 2014).

The core by its novel design attempts to either double or triple the chances to achieve favorable anti-cancer drug interactions, reverse drug resistance and chances for Vitamin C to impact anti-tumor efficacy compared to standard regimens.
The novel trial design allows every patient the early use of Vitamin C and to continue Vitamin C without interruption when there is evidence of benefit.

The investigators caution that this information should not be taken as a general recommendation for use of Vitamin C. Management of Vitamin C requires special monitoring and maintenance of dosage. Vitamin C may not be suitable for combination with some (other) drugs, nor be an effective protectant for standard regimens which produce high rates of severe adverse events. The trial is supported by a grant from The Marcus Foundation.

Contact: [email protected]  

Howard W. Bruckner MD, Medical Director
MZB Foundation for Cancer Research, Medical Director
718-732-4050

SOURCE Bruckner Oncology

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
All clouds are not equal. To succeed in a DevOps context, organizations should plan to develop/deploy apps across a choice of on-premise and public clouds simultaneously depending on the business needs. This is where the concept of the Lean Cloud comes in - resting on the idea that you often need to relocate your app modules over their life cycles for both innovation and operational efficiency in the cloud. In his session at @DevOpsSummit at19th Cloud Expo, Valentin (Val) Bercovici, CTO of Soli...
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for ...
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effici...
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
"MathFreeOn.com is a line coding platform for engineers and scientists. When they want to solve an engineering problem and they have to use software - they have to pay a lot of money for licenses - but with MathFreeOn you don't have to pay a lot of money. Just go to our site and write the code and you can check the result right away," explained Simon Lee, CMO of MathFreeOn, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Cla...
In his session at 19th Cloud Expo, Claude Remillard, Principal Program Manager in Developer Division at Microsoft, contrasted how his team used config as code and immutable patterns for continuous delivery of microservices and apps to the cloud. He showed how the immutable patterns helps developers do away with most of the complexity of config as code-enabling scenarios such as rollback, zero downtime upgrades with far greater simplicity. He also demoed building immutable pipelines in the cloud ...
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...