[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]

This page is linked to:
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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
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[12] – 1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [2 Pgs.]
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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

SRB/cf

cc:

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.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski
1994 (4/19/1994) – Burzynski to Dr. Mario Sznol [20] (2 pgs.)
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]

This page is linked to:
=====================================
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
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https://stanislawrajmundburzynski.wordpress.com/2013/09/08/critiquing-stanislaw-burzynski-on-the-arrogance-of-ignorance-about-cancer-and-targeted-therapies/
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[11] – 1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [2 pgs.]
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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

Pg. 2

Mario Sznol, M.D., Head, Biologics Evaluation Section, Investigational Drug Branch,Cancer Therapy Evaluation Program, Division of Cancer Treatment,
National Cancer Institute

cc:

David Parkinson, M.D.
Mike Friedman, M.D.
Dale Shoemaker, Ph.D.
Jay Greenblatt, Ph.D.
Dean Mouscher, BRI
Mary McCabe
Samuel Broder, M.D.
Bruce Chabner, M.D.
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1994 (3/23/1994) – Dr. Mario Sznol to Burzynski [20] (2 pgs.)
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