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

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

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has been replaced by the statement: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.


Jerome Posner, M.D.
Charles Young, M.D.
Mario Sznol, M.D. (NCI)
NCI-designated Comprehensive Cancer Center

1995 (1/31/1995) – to Dr. John L. Lewis [20]