[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski

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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
[15] – 1995 (4/3/1995) – Dr. Mario Sznol to Burzynski
Department of Health and Human Services, Public Health Services, National Institutes of Health, National Cancer Institutes

Dear Dr. Burzynski,

Dr. Friedman asked me to respond to your letter of 3/29/1995 regarding the change we have been considering in eligibility criteria for the Memorial Sloan-Kettering and Mayo Clinic phase II studies of antineoplastons

At the investigator’s request, the amendments to modify the eligibility restrictions for size of tumor, number of tumors, and leptomeningeal spread, and to allow entry of patients with KPS of 60, have been approved

These amendments were initiated by the investigators when it became apparent that many good candidates for the study were being excluded because of what were perceived to be overly stringent and unnecessary eligibility restrictions

Approximately a year ago, we wrote to you asking for your concurrence to make similar changes to the protocol

(see enclosed letter)

We have documented that the revised eligibility criteria are consistent with those used in your very own protocols that employ identical or nearly identical treatment regimens

Furthermore, in a review of the 7 patients in the best case series presented to NCI, we have found that perhaps 4 of the 7 patients who apparently had tumor shrinkage would not have been eligible to enter the NCI phase II studies under the original stringent eligibility criteria

(see attached)

These types of patients will now be eligible for study using the revised eligibility criteria proposed by the investigators and recently approved by CTEP

Despite the difficulties in accrual, we are committed to completing the phase II evaluation of the antineoplastons

Our goals remain unchanged, that is, we wish to determine whether the drugs used in the similar manner as you recommend, and in the similar population of patients, will yield results consistent with those in the best case series

As noted above, our careful evaluation of the materials you have provided indicate that the amendments to the eligibility criteria do not deviate from the eligibility criteria and methods you have employed in your experience

We would appreciate the opportunity to review your data, alluded to in your letter, that support the contention that inclusion of theses patients requires a different treatment regimen or is unsafe

In the meantime, we will allow the amendments to stand, since all evidence you have provided to date indicates that these newly eligible patients may have a chance for benefit without undue risk of harm, and are appropriate candidates for evaluation of the drug

We will forward the data on the 1st 5 patients in a separate mailing as you requested

Pg. 2

However, you have asked that we suspend accrual while you review the data

There is no medical or regulatory reason to suspend accrual at this time

Suspending accrual will likely further damage the efforts the investigators have made to increase accrual to the trial

Mario Sznol, M.D.


Dottie Tisevich
Michael Friedman, M.D.
Mary McCabe
Office of Alternative Medicine

Pg. 3

Antineoplaston Cases

1. Histology partial lobe glioblastoma multiforme
Size 2.3 cm largest diameter
Response CR possible
prior Tx RT, surgery

2. Histology anaplastic astrocytoma stage IV grade 3
Size 3.0 tumor 3.5 tumor and edema
Response CR possible
prior Tx RT

3. Histology infiltrating glioma (astrocytoma or mixed astrocytoma / oligodendroglioma)
Size 4.4
Response good PR, possible CR
prior Tx RT and BUdR; Procarbazine, CCNU, VCR; B-Interferon; DFMO and MGBG

4. Histology well differentiated Stage IV astrocytoma, possible juvenile pilocytic astrocytoma
Size 5.5 X 3.3
Response 40-50% decrease of solid component
prior Tx vitamins and laetrile

5. Histology glioblastoma multiforme
Size 6.5 x 5.0
Response 39% decrease
prior Tx RT

6. Histology glioma consistent with anaplastic astrocytoma, differential: anaplastic astrocytoma or spindle cell variant of oligodendroglioma
Size 5.1 x 2.2
Response CR
prior Tx RT

7. Histology Infiltrating anaplastic astrocytoma
Size 4.0 (L) 4.8 (bifrontal)
Response good response – possible CR
prior Tx RT

1995 (4/3/1995) – Dr. Michael A. Friedman to Burzynski [16]
1995 (4/3/1995) – Dr. Mario Sznol to Burzynski [21] (3 pgs.)
1995 (3/29/1995) – Burzynski to Dr. Michael A. Friedman