[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has been replaced by the statement: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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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network

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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[5] – 1991 (11/15/1991) – Dr. Michael J. Hawkins to Decision Network
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Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI)

Re: Antineoplaston

[7 pgs. – 1 pg.]

To: Decision Network

Attached is a summary of a review of a best case series of antineoplastons in the treatment of brain tumors which was conducted by CTEP at the Burzynski Research Institute and some background information on antineoplastons A10 and AS2-1

7 patient cases were presented at the site visit and the records, pathology slides and scans documenting response were reviewed

It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate

At the DN meeting, Dr. Burzynski will present some brief background data on antineoplastons and Dr. Nicholas Patronas, a neuroradiologist from the Clinical Center who was on the site visit team, will review the radiologic findings for the committee

Antineoplastons are being proposed for DN IV (Phase II trials)

We feel the 1st step is to confirm the observations of Dr. Burzynski in brain tumors

Initially 3 or 4 Phase II trials would be conducted (one trial in each of the following diseases: glioblastoma multiforme, anaplastic astrocytoma, pediatric brain tumors and possibly low grade astrocytomas) using antineoplaston A10 and AS2-1 in exactly the same manner Dr. Burzynski gave them in the cases we reviewed

A decision regarding subsequent trials (e.g.–other tumors, additional Phase I development, Phase III trials in brain tumors, etc) would be deferred until the results of these initial trials were known

Dr. Burzynski is willing to provide sufficient antineoplaston A10 and AS2-1 for these studies

The only impact on DCT would be the IND filing and the use of our clinical trials resources

cc: Dr. Burzynski

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