[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman to Burzynski (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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[22] – 1995 (9/19/1995) – Dr. Michael A. Friedman, Michael A. Friedman, M.D., Associate Director, Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment (DCT), National Cancer Institute (NCI), Department of Health & Human Services (HHS), Public Health Service, National Institutes of Health (NIH) 2 page letter to Burzynski

I am replying to your 8/29/1995, letter in which you requested “detailed records” of the patients treated in the National Cancer Institute sponsored trials of antineoplastons

Our records indicate that the data has been regularly supplied to you by our contractor, Theradex, as listed below:

Date Report

7/18/1994 Clinical Studies Summary
8/24/1994 Clinical Studies Summary
9/19/1994 Clinical Studies Summary
10/24/1994 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
11/14/1994 Clinical Studies Summary
12/19/1994 Clinical Studies Summary
1/13/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report
2/21/1995 Clinical Studies Summary
3/15/1995 Clinical Studies Summary
4/10/1995 Clinical Studies Summary
Monitors Detail Report
Clinical Studies Detail Report

Pg. 2

I am enclosing a summary of the categories of data that are included in the reports you have received

These reports are the same ones that have been provided to us by the contractor during the conduct of the Antineoplaston studies

Both the format and frequency of these reports are routine for reporting data of ongoing NCI Phase II trials to the Cancer Therapy Evaluation Program staff

These are also the same types of reports that are provided to pharmaceutical companies when they are cosponsors of a study

We have no individual patient records in our possession in addition to the Theradex reports

As of the last report provided to you of 4/10/1995, prior to the studies being put on hold and subsequently closed, you were sent the same reports that were provided to CTEP staff and protocols T93-0078 and T93-0134

However, enclosed for your convenience is a recent print-out of the data that was prepared for our staff in a slightly different format

Once the routine quality control review of data entry has been completed, we will send you a final print-out
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1995 (9/19/1995) – Friedman to Burzynski [18]
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[13] – 1995 (1/31/1995) – Dr. Mark G. Malkin to Dr. John L. Lewis (1 pg.)

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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[13] – 1995 (1/31/1995) – Dr. Mark G. Malkin to Dr. John L. Lewis (1 pg.)
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T93-0078

John L. Lewis, M.D., Chairman, Institutional Review Board, Memorial-Sloan-Kettering Cancer Center

RE: Protocol # 93-105

Dear Dr. Lewis

You will find appended to this covering letter an amended version of the approved IRB protocol # 93-105, entitled

“Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Advanced Recurrent Malignant Gliomas”

Further amendments, as described below, have been made at the request of NCI

The minor textual changes expand the pool of eligible patients, thus permitting us to recruit patients more rapidly; however, they do not otherwise alter the overall design of the protocol

1. In Sections 1.1-b) and 6.1-i) the permissible Karnofsky Performance Status Score has been lowered from 70% to 60%

2. In Sections 1.1-k) and 6-2.a) the exclusion criteria have been changed

The statement:

“Patients with tumors > 5 cm in diameter, multifocal turmors, or with laptomeningeal or systematic metastases are excluded

has been replaced by the statement:

There will be no exclusion based on tumor size, multifocality, or leptomeningeal or systemic metastases

I thank you for your assistance in this matter

Mark Malkin, M.D.

cc:

Jerome Posner, M.D.
Charles Young, M.D.
Mario Sznol, M.D. (NCI)
NCI-designated Comprehensive Cancer Center
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1995 (1/31/1995) – to Dr. John L. Lewis [20]
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