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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 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]
Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch, CTEP, DCT, National Cancer Institute
Dear Dr. Sznol,
I am glad to learn from your letter of 3/23/1994 that some patients have already been enrolled in the NCI-sponsored trials of Antineoplastons and there is a strong interest of the NCI and the Investigators to broaden the study
While I think that, ultimately, Antineoplastons would prove useful in the treatment of more advanced cases of malignant brain tumors, I think that to expand the trials now through admission of such difficult cases is premature
The 1st stage of the studies which are currently in progress should be completed in order to have the most accurate preliminary evaluation of anticancer activity
I sincerely hope that the Investigators conducting the study will report good results in the treatment of at least some of the initial 15 patients involved in stage I
However, if the reverse is true, then it won’t make any sense to conduct trials in very advanced cases if less advanced cases do not respond
I would expect that there would be a significant difference in response between the patients admitted under current acceptance criteria and the expanded eligibility criteria proposed in your letter of 3/23/1994
Therefore, I think that such patients should be involved in a separate trial for large and multifocal tumors, and treated and evaluated according to a modified protocol
David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe, R.N.
Samuel Broder, M.D.
Bruce Chabner, M.D.
1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol  (2 pgs.)