Bruckner Oncology trial tests a combination of Vitamin C and low dose chemotherapy
Aims to reproduce promising safety and efficacy findings
Bruckner Oncology, a cancer treatment specialist based in Bronx, NY, US, has begun an FDA approved Phase II-III clinical trial which adds Vitamin C to chemotherapy 'core' regimens for patients with locally advanced and metastatic pancreatic cancer (APC).
Bruckner says it chose Vitamin C for study because there has never been a formal clinical trial of this frequently used vitamin, which has long been credited with improving safety and quality of life during chemotherapy. Studies have also found that Vitamin C improves the effectiveness of chemotherapy for some tumours under laboratory conditions.
The company says a successful trial could benefit the nearly 50% of patients with APC and other cancers who are currently untreated or under-treated because of concerns about safety and efficacy.
The trial will attempt to reproduce Bruckner's pilot in which Vitamin C and the concurrent cores produced a less than 1% rate of clinically significant adverse events. The pilot group had many high risk patients. During Vitamin C co-treatment, patients with pre-existing symptoms and adverse events safely tolerated treatment and many improved, the company said. Standard treatments produce 10–40% rates of clinically significant severe adverse events, in trials limited to ideal low risk patients.
Studies have found that Vitamin C improves the effectiveness of chemotherapy for some tumours under laboratory conditions
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). Such patients, often untreated elsewhere, are eligible for safe treatment with cores including the elderly, the previously 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 that they may provide one of the safest treatment strategies for important anti-cancer drug classes. These regimens 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 either to double or triple the chances of achieving favourable anti-cancer drug interactions, reverse drug resistance and opportunities for Vitamin C to have an impact on anti-tumour efficacy compared with standard regimens.
The novel trial design allows every patient the early use of Vitamin C and to continue taking it without interruption when there is evidence of benefit.
Bruckner cautions 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. It may not be suitable for combination with some (other) drugs, nor provide effective protection for standard regimens that produce high rates of severe adverse events.
The trial is supported by a grant from The Marcus Foundation.
