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Burzyński and his assistants tried to prove clinical efficacy of antineoplastons with several clinical studies. The U.S. government register of clinical trials displays 60 entries (as of November 2011) by Burzynski Research Institute.<ref>[http://clinicaltrials.gov/ct2/results?spons=%22Burzynski+Research+Institute%22&spons_ex=Y Overview: clinical surveys of Burzynski Research Institute]</ref> The studies are criticized by oncologists due to "flawed research methods" and rated "scientific nonsense".<ref>[http://www.highbeam.com/doc/1P1-19476029.html Oncologists criticize methods of controversial cancer treatment], Terri Langford, Associated Press, Oktober 1, 1998</ref><ref>[http://www.ncbi.nlm.nih.gov/pubmed/15061600 Alternative cancer cures: "unproven" or "disproven"?], Vickers A., PubMed</ref> Randomized, controlled surveys could not replicate the Burzyński's results. Between 1991 and 1995, more than a million dollars were spent on independent studies at Mayo Clinic and Memorial Sloan Kettering.<ref>[http://ict.sagepub.com/content/3/1/59.abstract Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons], Mitchell R. Hammer, PhD, Wayne B. Jonas, MD, doi: 10.1177/1534735404263448, Integr. Cancer Therapies March 2004 vol. 3 no. 1 59-65</ref><ref name="HoustonPress" /> The studies were cancelled prematurely for ethical reasons because of the method's poor efficacy.<ref>Burzynski SR, Efficacy of antineoplastons A10 and AS2-1, 1999 Mayo Clin. Proc., vol 74 6 Seiten 641-2 PMID 10377942</ref><ref>Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Maes MM, Tong WPY, LIM S, Figg WD: Phase II study of Antineoplaston A10 (NSC 648539) and AS 2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc, 74, 137-145, 1999</ref>  

Burzyński and his assistants tried to prove clinical efficacy of antineoplastons with several clinical studies. The U.S. government register of clinical trials displays 60 entries (as of November 2011) by Burzynski Research Institute.<ref>[http://clinicaltrials.gov/ct2/results?spons=%22Burzynski+Research+Institute%22&spons_ex=Y Overview: clinical surveys of Burzynski Research Institute]</ref> The studies are criticized by oncologists due to "flawed research methods" and rated "scientific nonsense".<ref>[http://www.highbeam.com/doc/1P1-19476029.html Oncologists criticize methods of controversial cancer treatment], Terri Langford, Associated Press, Oktober 1, 1998</ref><ref>[http://www.ncbi.nlm.nih.gov/pubmed/15061600 Alternative cancer cures: "unproven" or "disproven"?], Vickers A., PubMed</ref> Randomized, controlled surveys could not replicate the Burzyński's results. Between 1991 and 1995, more than a million dollars were spent on independent studies at Mayo Clinic and Memorial Sloan Kettering.<ref>[http://ict.sagepub.com/content/3/1/59.abstract Managing Social Conflict in Complementary and Alternative Medicine Research: The Case of Antineoplastons], Mitchell R. Hammer, PhD, Wayne B. Jonas, MD, doi: 10.1177/1534735404263448, Integr. Cancer Therapies March 2004 vol. 3 no. 1 59-65</ref><ref name="HoustonPress" /> The studies were cancelled prematurely for ethical reasons because of the method's poor efficacy.<ref>Burzynski SR, Efficacy of antineoplastons A10 and AS2-1, 1999 Mayo Clin. Proc., vol 74 6 Seiten 641-2 PMID 10377942</ref><ref>Buckner JC, Malkin MG, Reed E, Cascino TL, Reid JM, Maes MM, Tong WPY, LIM S, Figg WD: Phase II study of Antineoplaston A10 (NSC 648539) and AS 2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc, 74, 137-145, 1999</ref>  

In December 2007, FDA granted https://en.wikipedia.org/wiki/Orphan_drug orphan drug] status to Burzyński's concoctions for the treatment of gliomas, a group of brain tumors hard to treat.<ref name="HoustonPress">http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/</ref> In 2009, FDA issued a caution against the institute due to violations of regulations for the protection of patients.<ref>[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm Warning letter FDA - Burzynski Research Institute / IRB]</ref>

In December 2007, FDA granted [https://en.wikipedia.org/wiki/Orphan_drug orphan drug] status to Burzyński's concoctions for the treatment of gliomas, a group of brain tumors hard to treat.<ref name="HoustonPress">http://www.houstonpress.com/2009-01-01/news/cancer-doctor-stanislaw-burzynski-sees-himself-as-a-crusading-researcher-not-a-quack/</ref> In 2009, FDA issued a caution against the institute due to violations of regulations for the protection of patients.<ref>[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm192711.htm Warning letter FDA - Burzynski Research Institute / IRB]</ref>

An independent review by American Cancer Society also arrived at negative results and recommended  patients not to spend money on antineoplaston treatments since there is no evidence of positive effects in treatment of cancer. A 2004 medical review described this treatment as a "disproven therapy".<ref name="acs">[http://caonline.amcancersoc.org/cgi/reprint/33/1/57.pdf Antineoplastons] - American Cancer Society on Antineoplastons ''CA Cancer J Clin'' 1983;33;57-59, DOI: 10.3322/canjclin.33.1.57</ref>.

An independent review by American Cancer Society also arrived at negative results and recommended  patients not to spend money on antineoplaston treatments since there is no evidence of positive effects in treatment of cancer. A 2004 medical review described this treatment as a "disproven therapy".<ref name="acs">[http://caonline.amcancersoc.org/cgi/reprint/33/1/57.pdf Antineoplastons] - American Cancer Society on Antineoplastons ''CA Cancer J Clin'' 1983;33;57-59, DOI: 10.3322/canjclin.33.1.57</ref>.