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
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...