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Critiquing: Dr. Michael A. Friedman, Dr. Mark G. Malkin, Dr. Mario Sznol, Robert B. Lanman, Memorial Sloan-Kettering Cancer Center, Mayo Clinic, Department of Health & Human Services (HHS), Public Health Service, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Center (NCI) at the National Institutes of Health (NIH), Stanislaw Burzynski: On the arrogance of ignorance about cancer and targeted therapies
 – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]
Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes
Dear Dr. Burzynski,
As you know, the NCI-sponsored trials of antineoplastons have been initiated and some patients have been enrolled
However, a great many more have sought access to the trial but have not been allowed to participate because of their inability to meet all the eligibility criteria
Because of this, there is strong interest on our part and that of the investigators to broaden the eligibility criteria
While we recognize the need for and value of clear eligibility criteria, we believe that the protocol now excludes some patients who would otherwise be good candidates for the trial
Specifically, we would propose the following changes in the eligibility criteria:
1. Change the allowable Karnofsky performance status from 70 to 60, as originally written in the protocol
2. Change the exclusion for size of tumor from greater than 5 cm to greater than 8 cm
3. Drop the exclusion for multifocal tumors or leptomeningeal spread
By keeping the performance status score at 60 as a requirement for entry, we believe that the protocol will still be safe for patients, and the drug will get a fair test for antitumor efficacy
We have noted that your protocols for adults (copies of which you have provided to CTEP) have similar eligibility criteria to those proposed above (ie, KPS of 60 required and no exclusion for size of tumor, multifocal tumor, or leptomeningeal spread)
We have also noted that some patients eligible for treatment on NCI-sponsored protocols appear to have been told by your staff that they could receive the antineoplastons at your institute
They have asked us the obvious question, that is, if you have enough evidence of efficacy to offer the antineoplastons as treatment to those patients, why is it that they would not be good candidates for a protocol attempting to determine and confirm the antitumor activity of the agent?
We would appreciate any help you might give us in responding to these inquiries
Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch,Cancer Therapy Evaluation Program, Division of Cancer Treatment,
National Cancer Institute
David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Samuel Broder, M.D.
Bruce Chabner, M.D.
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski  (2 pgs.)