[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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[3] – 1991 (10/30/1991) – Dr. Dorothy K. Macfarlane Memorandum – 10/4/1991 – site visit (5 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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[3] – 1991 (10/30/1991) – Dr. Dorothy K. Macfarlane Memorandum – 10/4/1991 – site visit (5 pgs.)
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Dorothy K. Macfarlane, M.D., Head, Quality Assurance and Compliance Section, Regulatory Affairs Branch (RAB), Cancer Therapy Evaluation Program (CTEP), Department of Health &Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI)

Review of Brain Tumor Cases Treated With Antineoplastons

On 10/4/1991, Cancer Therapy Evaluation Program (CTEP) staff (Dr. Michael Hawkins, Dr. Michael Hamilton, Dr. Dorothy Macfarlane) and invited consultants (Dr. Nicholas Patronas, neuroradiologist, National Institutes of Health (NIH) Clinical Center, and Dr. James Nelson, neuropathologist, AFIP) visited the offices of Dr. Stanislaw Burzynski in Houston, Texas to review 7 selected brain tumor cases which Dr. Burzynski felt represented the best responses achieved with Antineoplastons A10 and AS2-1 treatment

Following is a summary of each case history, as described by Dr. Burzynski, and the assessment of slides and scans by the review team

Patient #1 (E.L.)
Patient #2 (P.W.)

Pg. 2

Patient #2 (P.W.)
Patient #3 (J.K.)

Pg. 3

Patient #3 (J.K.)
Patient #4 (P.M.)
Patient #5 (H.E.)

Pg. 4

Patient #5 (H.E.)
Patient #6 (R.W.)

Pg. 5

Patient #6 (R.W.)
Patient #7 (H.M.)

Dorothy K. Macfarlane, M.D.

Distribution:

Dr. Michael Friedman
Dr. Michael Hawkins
Dr. Michael Hamilton
Dr. Nicholas Patronas
Dr. James Nelson
Dr. Michael Grever

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