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Dana-Farber Cancer Board Member discusses Dr. Burzynski, Antineoplastons, & Industry

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Dana-Farber Cancer Institute Board of Directors Member James Rappaport discusses Dr. Burzynski and The Cancer Industry
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“When you look at what is going on and how Dr. Burzynski’s being handled, it is clearly a function of, (?), anytime you have big business, big government, big labor, Big Pharma, Big Cancer Industry, whatever, they become so, wrapped up in protecting the institution; whatever it is, that they forget what their fundamental job is, you know, and what’s happened with Big Pharma and, and Big Cancer, is they kinda, you know, they’ve forgotten to be curious that there might be other op, opportunities and options out there, and they’re focused on protecting their turf”
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00:41 – Peer-review chauvinism
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“Most of the stuff is peer-reviewed, in order to get into, the starting gate, of their process”

“Well, if you’re all of the peers, are vested in one piece of the business, something new, is frightening, and is not going to be given the same shot, as something that’s within the construct of what they’re used to”

“That’s the problem, uh, and the idea that something different; less catastrophic to the body, um, could possibly, uh, work, would upset all of their training, all of their thinking, and, it, it’s very hard for them to, to to do that”
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01:24 – The anointed Evangelical Guardians of the Status Quo
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“The doctors I know and, and the clinicians I know, and, and these people are evangelical”

“I mean, they are hugely, vested and invested, in doing what they believe is very important and good work”

“It helps them get up in the morning, to go to work”

“So, folks who are, invested that kind of, uh, you know, zealous way, you know, are going to look at anything that isn’t within that, that, that, that vision, you know, they’re going to look askance at it”

“They’re going to look at, say that, that, that’s really weird, or, that’s a charlatan”

“What they were in essence saying is, that if you do, the Burzynski treatment regimen, you are foregoing the treatments that we know and understand, and thus we can’t, guarantee that you’re going to have a success”

“Well, you can’t guarantee that you’re going to have a success with chemotherapy, or the normal regimens of chemotherapy“

“So, they came from a place of saying: ‘We are protecting you from going down and taking a, uh, the placebo approach,’ which is the way they look at it”

“The fact that it’s been effective, and the fact that, uh, you know, when you go through the numbers, uh, and the analysis, and you go through, uh, that if you’ve not gone through chemotherapy, and you go through the Burzynski’s treatment your odds are 2 or 3 times as high, even if you have gone through chemotherapy it’s 1 or 2 times as high”

“You know, those are, un, those are high enough numbers to push the needle, and, oh by the way, it’s less expensive, than Big Pharma“
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02:56 – Protecting the business at all costs
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“Which is another big piece”

“Big Pharma is protecting a huge, multi-billion dollar business, and they’re going to protect it to the death, even, to the adverse impact of patient outcomes”

“They won’t say it that way, and, but that fact of the matter is, if you’ve got an approach out here which could be significantly, less costly, and significantly less adversely impact-full, to the patient, um, then you’re gonna, um, you, you, you can understand why they’re, to doing”

“You don’t have to agree with it, but you can at least understand why they’re taking the position that they’re taking”
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03:34 – The fiber of an innovator’s background
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“I think that what is amazing is that Dr. Burzynski has had a vision, and a passion, and a zeal, for 40-odd years, put up with being called everything, short of, and probably even including ‘Witch Doctor,’ um, because of his firm belief that he can save people’s lives, and, and what that says about his character and his just his, the fiber of his backbone, to, um, to be willing to take that on”

“You know, you’re talking about a man who spent the last 40 years, um, you know, working on, on a different form of treatment that is more patient friendly, than chemotherapy“

“You know, I explain to people about, you know, what chemotherapy is”

“What chemotherapy is, is putting poison in your body”

“Killing everything that is fast-growing in your body”

“Starting first with cancer cells”

“Then next with white-blood cells”

“Then with your hair”

“Then with your, you know, the inside lining of your mouth”

“Um, then your fingernails”

“I mean, you know, that, that’s what it’s meant to do, and what you essentially do is you give this chemotherapy to, as much as a person can take, uh, uh, uh, in order to, you know, in, in, in order to get out the other end where’ve you’ve killed cancer and hopeful not everybody else or the patient”

“That’s what it is”

“So, if you’ve got a different approach, which is, essentially is saying, well, you know, we’re not, we’re gonna go in and stop the cancer cells from growing and we’re going to actually, and, uh and work on shrinking them, without the ancillary effects, is pretty powerful, you know, and, uh, and you would think that, that, that, the Big Cancer Industry would say: ‘That’s something we outta be looking at'”

Burzynski needs to be given the right to prove the efficacy of his treatment, and if he can, uh, show that his treatments are as or more effective, and / or, significantly better for the patient, with better patient outcomes and, and limited side effects, he’s gotta be given that opportunity to compete out in the marketplace”

“That’s what America’s about”
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12/4/2013 – Jim Rappaport, Board Member of Dana-Farber Cancer Institute discusses Dr. Burzynski and the obstacles he faces within a Cancer Ind (5:49)
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Click to access dana-farber-board-of-trustees.pdf

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http://www.rappaportfoundation.org/about/board.html
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http://www.specialtyhospitalsofamerica.com/jim-rappaport/
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http://www.petangelworldservices.com/board.php?bio=rappaport
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http://www.newbostonfund.com/Company-Overview/Executive-Team/James-Rappaport.asp
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Antineoplastons: Adverse Effects

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National Cancer Institute (NCI) at the National Institutes of Health (NIH)
Antineoplastons
Adverse Effects:
http://www.cancer.gov/cancertopics/pdq/cam/antineoplastons/healthprofessional/page6
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http://www.burzynskiclinic.com/scientific-publications.html
Interim Reports on Clinial Trials:
�
1. 10/2003
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R.A., Bestak, M., Lewy, R.I., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in children with recurrent and progressive MULTICENTRIC GLIOMA
�
A preliminary report

Click to access 970.pdf

Neuro-Oncology. 2003; 5: 358
Volume 5 Issue 4 October 2003
�
12 patients
�
10 evaluable
�
1 – serious (grade 3) toxicity: reversible tinnitus
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
16. 2003
�
DRUGS IN R&D
Drugs in R and D
(Drugs in Research and Development)
�
BT-11
�
BRAIN STEM GLIOMA
�
Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic BRAIN STEM GLIOMA:
�
a preliminary report.
http://www.ncbi.nlm.nih.gov/pubmed/12718563
Burzynski, S.R., Lewy, R.I., Weaver, R.A., Axler, M.L., Janicki, T.J., Jurida, G.F., Paszkowiak, J.K., Szymkowski, B.G., Khan, M.I., Bestak, M.
http://www.ncbi.nlm.nih.gov/m/pubmed/12718563
Drugs R D. 2003;4(2):91-101
Drugs in R&D 2003;4:91-101

Click to access 960.pdf

12 patients
�
10 evaluable
�
Pg. 96
�
Only mild and moderate toxicities were observed, which included:
3 – skin allergy
2 – anaemia
2 – fever
2 – hypernatraemia
1 – agranulocytosis
1 – hypoglycaemia
1 – myalgia
1 – numbness
1 – tiredness
1 – vomiting
� � � � � � � � � � � � � � � � �
Review Articles on Clinical Trials:
�
1. 3/2004
�
INTEGRATIVE CANCER THERAPIES
�
Burzynski, S.R.
�
The Present State of Antineoplaston Research

Click to access 994.pdf

Integrative Cancer Therapies 2004;3:47-58
Volume 3, No. 1, March 2004
DOI: 10.1177/1534735-403261964
�
Pg. 56
�
Adverse Reactions
�
Serious adverse reactions:
1.4% – anemia
0.5% – hypernatremia and fever
�
Moderate adverse reactions:
0.76% – skin rash
0.9% – slurred speech
�
Most patients experience increased diuresis, which may lead to dehydration and thirst
�
Adverse reactions observed have usually been transient and mild
�
Noted in our studies and due to phenylacetate, which is the main ingredient of AS2-1:
confusion
Reversible grade 1 somnolence
�
It’s suspected other adverse reactions observed in our studies were due to A10.
�
They weren’t observed by Buckner et al since they used approximately 50 times lower dosages of A10 in their study.
�
On the other hand, A10 induces diuresis, which may result in rapid elimination of AS2-1 through kidneys, which will lower concentration of AS2-1 in plasma and reduce chances for higher grade toxicity observed by Buckner et al. [49]
�
49. Burzynski SR. Efficacy of antineoplastons A10 and AS2-1.
http://www.ncbi.nlm.nih.gov/pubmed/10377942/
Mayo Clin Proc. 1999;74:641-642.
http://www.ncbi.nlm.nih.gov/m/pubmed/10377942/
Mayo Clin Proc. 1999 Jun;74(6):641-2.
http://www.sciencedirect.com/science/article/pii/S0025619611641438
Mayo Clinic Proceedings
Volume 74, Issue 6 , Page 641, June 1999
�
Buckner et al described:
reversible grade 2 or 3 neurological toxicity, consisting of:
confusion
exacerbation of an underlying seizure disorder
transient somnolence
[48]
�
48. Buckner JD, Malkin MG, Reed E, et al. Phase II study of antineoplaston A10 (NSC 648539) and AS2-1 (NSC 620061) in patients with recurrent glioma. Mayo Clin Proc. 1999;74:137-145.
http://www.ncbi.nlm.nih.gov/pubmed/10069350/
Mayo Clin Proc. 1999 Feb;74(2):137-45.
http://www.ncbi.nlm.nih.gov/m/pubmed/10069350/
Mayo Clinic Proceedings
Volume 74, Issue 2, February 1999, Pages 137–145
http://www.sciencedirect.com/science/article/pii/S0025619611638354
Department of Oncology, Mayo Clinic Rochester, Minnesota, USA.
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Case Reports:
�
4. 9/2004
�
INTEGRATIVE CANCER THERAPIES
�
Special exception (SE) to BT-11
�
BRAIN STEM GLIOMA
�
Burzynski, S.R., Lewy, R.I., Weaver, R., Janicki, T., Jurida, G., Khan, M., Larisma, C.B., Paszkowiak, J., Szymkowski, B.
�
Long-term survival and complete response of a patient with recurrent diffuse intrinsic brain stem GLIOBLASTOMA MULTIFORME

Click to access 1145.pdf

Integrative Cancer Therapies 2004;3:257-261
Volume 3, Number 3 September 2004
DOI: 10.1177/1534735404267748
�
Pg. 257
�
40 – age
�
Mild reversible side effects
�
Pg. 258
�
9/30/2009 – admitted for administration of treatment
Mild hypernatremia – On several occasions discontinued treatment from 1 to 3 days
Increased fatigue – off treatment 2 days
3/29/2000 – White blood cell (WBC) count decreased and discontinued treatment for 3 days
�
Pg. 259
�
7/10/2000 – White blood cell (WBC) count decreased and discontinued treatment until treatment restarted 7/13/2000
7/15/2000 – discontinued treatment elevation of transaminases (serum glutamic oxaloacetic transaminase; serum glutamic pyruvic transaminase) until restarted 7/28/2000
8/2001 – developed persistent diarrhea and was referred to a gastroenterologist, but there were no pathological findings except for changes related to obesity
8/21/2001 treatment discontinued due to resolution of tumor
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Interim Reports on Clinial Trials:
�
2. 10/2004
�
NEURO-ONCOLOGY
�
BT-20
�
Patients With GLIOBLASTOMA MULTIFORME (GBM)
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Weaver, R.A., Burzynski, S.R., Bestak, M., Lewy, R.I., Janicki, T.J., Szymkowski, B., Jurida, G., Khan, M.I., Dolgopolov, V.
�
Phase II study of Antineoplastons A10 and AS2-1 (ANP) in recurrent GLIOBLASTOMA MULTIFORME

Click to access 1218.pdf

Neuro-Oncology. 2004; 6: 384
Volume 6 Issue 4 October 2004
Abstracts from the Society for Neuro-Oncology Ninth Annual Meeting, Toronto, Ontario, Canada, November 18-21, 2004
�
22 evaluable patients
(6 men / 16 women / 27-63 /47 – median age)
�
Pg. 385
�
2 – grade toxicity: hypernatremia
2 – grade toxicity: somnolence
1 – grade 3 toxicity: anemia
1 – fatigue
1 – fever
1 – headache
1 – nausea
1 – tinnitus
1 – vomiting
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Interim Reports on Clinial Trials:
�
3. 10/2004 (DBSG)
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Lewy, R.I., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Long-term survivals in phase II studies of Antineoplastons A10 and AS2-1 (ANP) in patients with diffuse intrinsic BRAIN STEM GLIOMA

Click to access 1219.pdf

Neuro-Oncology. 2004; 6: 386
Volume 6 Issue 4 October 2004
�
60 patients
(31 treated under Special Exception)
�
1 – reversible grade 3 toxicity: anemia
1 – reversible grade 3 toxicity: hypertension
1 – reversible grade 3 toxicity: hypokalemia
1 – reversible grade 3 toxicity: neutropenia
1 – reversible grade 3 toxicity: allergic skin rash
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
4. 10/2004 (AT/RT of CNS)
�
NEURO-ONCOLOGY
�
Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Jurida, G., Szymkowski, B., Khan, M., Dolgopolov, V.
�
Phase II studies of antineoplastons A10 and AS2-1 (ANP) in children with atypical teratoid/rhabdoid tumors (AT/RT) of the central nervous system
�
A preliminary report

Click to access 1146.pdf

Neuro-Oncology. 2004; 6: 427
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology, Boston, Massachusetts, June 13-16, 2004
�
11 children patients
(7 treated under Special Exception)
�
8 evaluable
�
1 – serious toxicity: reversible hypernatremia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
5. 10/2004
�
NEURO-ONCOLOGY
�
BT-12
�
CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
�
Burzynski, S.R., Weaver, R. Bestak. M., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Treatment of PRIMITIVE NEUROECTODERMAL TUMORS (PNET) with antineoplastons A10 and AS2-1 (ANP)
�
Preliminary results of phase II studies

Click to access 1147.pdf

Neuro-Oncology. 2004; 6: 428
Volume 6 Issue 4 October 2004
Abstracts from the Eleventh International Symposium on Pediatric Neuro-Oncology
�
17 patients
(12 months – 23 / 6 – median age)
�
15 evaluable
�
1 – serious side effect: anemia
1 – serious side effect: fever
1 – serious side effect: granulocytopenia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
18. 6/2005
�
INTEGRATIVE CANCER THERAPIES
�
BT-12
�
CHILDREN WITH PRIMITIVE NEUROECTODERMAL TUMORS (PNET)
�
CAN-01
�
CAN-1
�
PATIENTS WITH REFRACTORY MALIGNANCIES
�
Burzynski, S.R., Weaver, R.A., Janicki, T., Szymkowski, B., Jurida, G., Khan, M., Dolgopolov, V.
�
Long-term survival of high-risk pediatric patients with PRIMITIVE NEUROECTODERMALTUMORS treated with Antineoplastons A10 and AS2-1
http://www.ncbi.nlm.nih.gov/pubmed/15911929
Integrative Cancer Therapies 2005;4(2):168-177
http://www.ncbi.nlm.nih.gov/m/pubmed/15911929
Integr Cancer Ther. 2005 Jun;4(2):168-77

Click to access 1220.pdf

DOI: 10.1177/1534735405276835
http://m.ict.sagepub.com/content/4/2/168.long?view=long&pmid=15911929
Pg. 168
�
13 children patients – recurrent disease or high risk
�
10 males / 3 females
�
(1 – 11 – age / 5 years, 7 months – median age)
�
3 – younger than 3
�
Pgs. 168 and 170
�
8 – Medulloblastoma
3 – pineoblastoma
2 – other PRIMITIVE NEUROECTODERMALTUMORS (PNET)
�
Pg. 168
�
10-BT-12 (7 males / 3 females)
�
3 – CAN-01 (3 males)
�
Pgs. 168 and 173
�
serious side effects:
1 – anemia
1 – fever
1 – granulocytopenia
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
7. 7/2005
�
Burzynski, S.R., Weaver, R.A., Janicki, T.J., Burzynski, B., Jurida, G. Targeted therapy with ANP in children less than 4 years old with inoperable BRAIN STEM GLIOMAs. Neuro-Oncology. 2005; 7:300.

Click to access 1224.pdf

Volume 7 Issue 3 July 2005
Abstracts from the World Federation of Neuro-Oncology Meeting
�
2 trials
�
Intrinsic diffuse brain stem glioma (BSG)
�
10 assessable patients
�
Less than 4 years old
(3 months – 3 years)
�
7 – no biopsy: dangerous tumor location
2 – anaplastic astrocytoma
1 – pilocytic astrocytoma
�
Serious toxicities:
Reversible anemia
Hypokalemia
�
No chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-03
�

�
BT-11
�
BRAIN STEM GLIOMA (BSG)
�
BT-18
�
6. MIXED GLIOMA
�
ADULT PATIENTS WITH MIXED GLIOMA
�
“mixed glioma”, a type of PMBT
�
CAN-01
�
CAN-1
�
PATIENTS WITH REFRACTORY MALIGNANCIES
�
19. 3/2006
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Burzynski, B. Targeted therapy with Antineoplastons A10 and AS2-1 of high grade, recurrent, and progressive BRAINSTEM GLIOMA. Integrative Cancer Therapies 2006;5(1):40-47
http://www.ncbi.nlm.nih.gov/pubmed/16484713
Integr Cancer Ther. 2006 Mar;5(1):40-7
http://www.ncbi.nlm.nih.gov/m/pubmed/16484713
DOI: 10.1177/1534735405285380

Click to access 5825.pdf

�
http://m.ict.sagepub.com/content/5/1/40.long?view=long&pmid=16484713
Pg. 40
�
4 phase 2 trials
�
BRAINSTEM GLIOMA (BSG)
�
patients with inoperable tumor of high-grade pathology (HBSG)
glioblastoma
�
recurrent diffuse intrinsic glioblastomas and ANAPLASTIC ASTROCYTOMAs of brainstem
�
Pgs. 40 – 41 and 42
�
4 – glioblastomas (gliobastoma multiforme (GBM)) (GBM / BSG)
�
14 – anaplastic HBSG (patients with inoperable tumor of high-grade pathology (HBSG)) (Anaplastic astrocytoma / Anaplastic astrocytoma/mixed glioma)
�
14 – diffuse intrinsic tumors
�
12 – recurrence
�
18 patients
�
Pg. 42
�
(8 males / 10 females)
�
2 – 42 – age (10 – median age)
�
Pg. 43
�
BT-03 – 1 / female
BT-11 – 13 (8 males/5 females)
BT-18 – 1 / female
BT-22 – 2 / females
CAN-01 – 1 / female
�
Pg. 44
�
High-grade, recurrent, and progressive brainstem gliomas
�
Pgs. 40 and 45
�
Antineoplastons tolerated very well
1 – grade 4 toxicity (reversible anemia)
�
Pg. 45
�
2 – grade 3 toxicities: reversible anemia
�
Generally, the treatment was well tolerated and was free from chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
8. 10/2006
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B.G., Khan, M.I., Dolgopolov, V. Treatment of multicentric BRAINSTEM GLIOMAs with antineoplastons (ANP) A10 and AS2-1. Neuro-Oncology. 2006; 8:466.

Click to access 2105.pdf

Volume 8 Issue 4 October 2006
Abstracts for the Eleventh Annual Meeting of the Society for Neuro-Oncology (SNO)
�
Brainstem gliomas and multicentric tumors (MBSG)
�
19 evaluable patients
�
3.9 – 40.8 (9.2 – median age)
�
(90% less than 18 years old)
�
95% diffuse intrinsic brain stem glioma
5% cervicomedullary tumor
�
The patients didn’t experience any serious toxicities (grades III – IV), and there were no chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
9. 4/2007 (NDBSG)
�
Burzynski, S.R., Weaver, R.A., Janicki, T.J., Jurida, G.F., Szymkowski, B.G., Kubove, E. Phase II studies of Antineoplastons A10 and AS 2-1 (ANP) in children with newly diagnosed diffuse, intrinsic BRAINSTEM GLIOMAs. Neuro-Oncology 2007; 9:206.

Click to access 4021.pdf

Volume 9 Issue 2 April 2007
Abstracts from the Twelfth International Symposium on Pediatric Neuro-Oncology
�
20 assessable children
�
3 months – 20 – age
�
5 – high-grade gliomas
�
Serious toxicities included:
5 – anemia
1 – elevation of transaminases
1 – hypokalemia
1 – skin rash
There were no chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
10. 6/2008 (OPG)
�
BT-23 – CHILDREN WITH VISUAL PATHWAY GLIOMA
�
Phase II study of antineoplastons A10 and AS2-1 (ANP) in CHILDREN WITH optic PATHWAY GLIOMA:
�
A preliminary report

Click to access 7287.pdf

Neuro-Oncology 2008; 10:450
Volume 10 Issue 3 June 2008
�
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Samuel, Shiney
Szymkowski, Barbara G.
Walczak, Marek
Weaver, Robert A.
�
16.5 months (1 year 4.5 months) – Median antineoplaston treatment
�
6/2008 – Protocol – CHILDREN WITH optic PATHWAY GLIOMA
�
12 Evaluable Children Patients
(7 months – 16 years / 6 years 3 months – Median age)
——————————————————————
0 – lost to follow-up
——————————————————————
No grade 3 or 4 toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
11. 10/2008
�
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA
9)
�
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA
17)
�
Phase II study of antineoplastons A10 and AS2-1 (ANP) in PATIENTS WITH newly diagnosed ANAPLASTIC ASTROCYTOMA:
�
A preliminary report

Click to access 7853.pdf

Volume 10 Issue 5 October 2008
Neuro-Oncology 2008; 10:821
Abstracts for the Thirteenth Annual Meeting of the Society for Neuro-Oncology, November 20-23, 2008
�
Burzynski, Gregory
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Samuel, Shiney
Szymkowski, Barbara G.
Weaver, Robert A.
�
FDA monitored study
�
5.7 months – Median Duration of Treatment
�
10/2008 – Protocol – Patients with Newly Diagnosed ANAPLASTIC ASTROCYTOMA (AA)
�
20 Evaluable Patients
(22 – 64 years / 40 – Median age)
——————————————————————
2 / 10% – grade 3 toxicity possibly related to antineoplastons (ANP)
(Shortness of breath / generalized weakness)

Interim Reports on Clinical Trials:
�
12. 12/2008
�
(BT-8 – PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 9)
�
(BT-15 – ADULT PATIENTS WITH ANAPLASTIC ASTROCYTOMA: 17)
�
Phase II study of antineoplastons A10 and AS2-1 infusions (ANP) in PATIENTS WITH recurrent ANAPLASTIC ASTROCYTOMA

Click to access 7898.pdf

Neuro-Oncology 2008; 10:1067
Volume 10 Issue 6 December 2008
Abstracts for the Eighth Congress of the European Association for Neuro-Oncology (EANO), Sept. 12-14, 2008, Barcelona, Spain
�
Burzynski, Gregory
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Walczak, Marek
Weaver, Robert A.
�
6.5 months – Median duration of treatment
�
FDA-monitored phase II clinical trial
�
12/2008 – Protocol – ADULTS WITH recurrent ANAPLASTIC ASTROCYTOMA (AA)
�
20 – Evaluable Assessable Adult Patients
(20 – 51 years / 41 – Median age)
——————————————————————
1 / 5% – serious toxicity of hypernatremia
� � � � � � � � � � � � � � � � �
Case Reports:
�
BT-11 special exception (SE)
�
BRAIN STEM GLIOMA
�
1. 12/2009
�
Weaver, R.A., Szymkowski, B., Burzynski, S.R. Over a 10-year survival and complete response of a patient with diffuse intrinsic BRAINSTEM GLIOMA (DBSG) treated with antineoplastons (ANP). Neuro-Oncology 2009; 11:923.

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Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan
�
10.5 – age / female
�
1 episode of grade 3 vomiting which resolved within 3 days
� � � � � � � � � � � � � � � � �
Interim Reports on Clinial Trials:
�
BT-11
�
BRAIN STEM GLIOMA
�
13. 12/2009 (DBSG)
�
Burzynski, S.R., Janicki, T.J., Weaver, R.A., Szymkowski, B., Burzynski, G.S. Phase II study of antineoplastons A10 and AS2-1 in patients with BRAINSTEM GLIOMA. Protocol BC-BT-11. Neuro-Oncology 2009, 11:951.

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Volume 11 Issue 6 December 2009
Abstracts from the Third Quadrennial Meeting of the World Federation of Neuro-Oncology (WFNO) and the Sixth Meeting of the Asian Society for Neuro-Oncology (ASNO)
May 11-14, 2009
Yokohama, Japan
�
40 patients
�
12 not evaluable
�
28 evaluable (ST) (23 children / 5 young adults)
�
12 – newly diagnosed / 16 previously treated)
�
Additional 52 evaluable (40 children / 12 young adults) treated under special exception (SE) (18 newly diagnosed)
�
ANP was well tolerated with serious toxicities occurring in less than 10% of patients in both groups:
anemia
dyspnea
elevated transaminases
fatigue
hypernatremia
hypokalemia
polyuria
skin rash
somnolence
subcutaneous extravasation
vomiting
�
No chronic toxicities
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
14. 6/2010
�
BT-13 – CHILDREN WITH LOW GRADE ASTROCYTOMA
�
A Phase II Study of Antineoplaston A-10 and AS-1 Injections in CHILDREN WITH LOW-GRADE ASTROCYTOMAs.

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Neuro-Oncology 2010; 12, ii95.
Volume 12 Issue 6 June 2010
�
Acelar, Sheryll S.
Burzynski, Gregory S.
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Weaver, Robert A
�
17 / 100% – Evaluable for Safety
�
12 or more weeks or at least 4 weeks of Antineoplastons (ANP) but developed Progressive Disease (PD)
Patients Evaluable for Efficacy
�
83 weeks – Median Antineoplastons (ANP) (15 / 100% – Evaluable Patients)
�
6/2010 – Protocol – CHILDREN WITH Recurrent and / or Progressive LOW-GRADE ASTROCYTOMA (LGA)
�
17 Patients Accrued
(20 months {1 year 8 months} – 210 months {17 years 6 months} / 129 months {10 years 9 months} – Median age)
15 Evaluable Patients
�
Patients Showing Stable Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
Patients Showing Progressive Disease (47 – 85 days / 60 – Median days of Antineoplastons (ANP))
——————————————————————
Minimal toxicity
� � � � � � � � � � � � � � � � �
Interim Reports on Clinical Trials:
�
15. 11/2010
�
BT-18 – ADULT PATIENTS WITH MIXED GLIOMA
�
Preliminary Results of a Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in Adult Patients with Recurrent Mixed Gliomas.

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Neuro-Oncology 2010; 12:iv72.
Volume 12 Supplement 4 November 2010
�
Acelar, Sheryll S.
Burzynski, Gregory S.
Burzynski, Stanislaw Rajmund
Janicki, Tomasz J.
Szymkowski, Barbara G.
Weaver, Robert A
�
7 / 35% – not evaluated due to inadequate duration of treatment and lack of follow-up Magnetic Resonance Imaging (MRI) scans
�
4.4 months – median duration of treatment
�
11/2010 – Protocol – Adult Patients with Recurrent Mixed Gliomas
�
20 – Children Patients Accrued
13 – Evaluable Patients
(9 men / 4 women: 29 – 54 years / 38 – Median age)
——————————————————————
Antineoplastons (ANP) was well tolerated with the most common side effects being:
Dysgeusia
Hypernatremia
Hypersensitivity
Myalgias
Nausea
Urinary frequency
�
1 – Serious (grade 3) toxicity (urinary frequency)
�
No grade 4 toxicities