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Antineoplastons (PDQ®)
Patient Version   Health Professional Version   Last Modified: 04/24/2008
Table 2. Antineoplastons Clinical Trials

Reference Citations  Type of Study   Type(s) of Antineoplaston   Type(s) of Cancer   No. of Patients   Strongest Benefit Reported   Concurrent Therapy  
[1] Nonconsecutive case series A Various types 21 Complete remission (2 grade III bladder cancers, stage IV breast cancer, ALL)a Nob
[3] Nonconsecutive case series AS2-1 (8 pts) Various types, most in advanced stages 20 Complete remission (stage IA cervical, intraductal breast carcinoma, stage IV lymphocytic lymphoma)c Nod
AS2-1 plus other antineoplaston formulations (12 pts)
[5] Nonconsecutive case series AS2-5 (11 pts) Various types, advanced stages 13 Complete remission (stage II laryngeal, stage III NSCLC)e No
AS2-5 plus AS2-1 (2 pts)
[2] Nonconsecutive case series A10 (12 pts) Various types, most in advanced stages 18 Partial remission (one case stage IB chondrosarcoma)f No
A10 plus other antineoplaston formulations (6 pts)
[7] Nonconsecutive case series A3 Various types, advanced stages 24 Complete remission (bladder carcinoma, basal cell epithelioma, and colon cancer)g No
[8] Nonconsecutive case series A5 Various types, advanced stages 15 Complete remission (grade III mixed bladder cancer)h Not specified
[17] Consecutive case series (phase II trial) AS2-1 Prostate cancer, hormone refractory (13 stage IV, 1 stage II) 14 Complete remission (2 pts)i Yesj
[9] Nonconsecutive case series/case reports AS2-1, A10 Brain tumors 9 Partial response (1 pontine glioma, 1 metastatic brain tumor)k Yesl
[19] Phase I clinical trial A10, AS2-1 (randomly chosen) Various types, advanced stages 42m Complete response (3 tumors)k Yesn
[4] Case reports A10, AS2-1 Various types 3 Reduction in tumor size (stage IV breast, stage IIIB NSCLC) Yeso
[18] Case reports A10, AS2-1 Advanced hepatocellular carcinoma 2 Slight shrinkage of tumor thrombus in the portal vein p Yesq
[10] Phase II clinical trial A10, AS2-1 Recurrent brain tumor (anaplastic astrocytoma or glioblastoma multiforme) 9 (6 pts were assessable for efficacy) Noner No
[13] Phase II study A10, AS2-1 Recurrent and progressive multicentric glioma in children 12 Complete response 2 No
Nonevaluable 1
[12] Phase II study A10, AS2-1 Recurrent diffuse intrinsic brain stem glioma 12 Complete response 2 No
[4] Case reports A10, AS2-1 Various types 3 Reduction in tumor size (stage IV breast, stage IIIB NSCLC) Yess
[18] Case reports A10, AS2-1 Advanced hepatocellular carcinoma 2 Slight shrinkage of tumor thrombus in the portal veint Yesu
[10] Phase II clinical trial A10, AS2-1 Recurrent brain tumor (anaplastic astrocytoma or glioblastoma multiforme) 9 (6 assessable for efficacy) Nonev No
[13] Phase II study A10, AS2-1 Recurrent and progressive multicentric glioma in children 12 Complete response 2 No
Nonevaluable 1
[12] Phase II study A10, AS2-1 Recurrent diffuse intrinsic brain stem glioma 12 Complete response 2 No
[14] Phase II study A10, AS2-1 Primitive neuroectodermal tumor 13 Complete response 3 No
[16] Summary of data, phase II trials A10, AS2-1 Recurrent diffuse intrinsic brainstem glioma 18 (2 previously reported in [13]) Complete response 1 (1 previously reported) No

No. = number; pt/pts = patient/patients.
aReported at 9 months of follow-up; patient with breast cancer had undergone radical mastectomy, radiation therapy, and chemotherapy and had subsequent metastases to ribs surgically resected prior to treatment with antineoplastons.
bOne patient with bladder cancer had surgery for removal of necrotic tumor.
cReported at 5 years of follow-up; patient with stage IA cervical cancer received prior radiation therapy; patient with breast cancer received prior radical mastectomy and had no measurable disease at the initiation of antineoplaston treatment.
dOne patient received 5-fluorouracil.
eReported at 5 years of follow-up; patient with stage II laryngeal cancer was reported to be in complete remission 730 days after beginning of treatment, but was lost to follow-up at time of study publication and his status was unknown; patient with stage III NSCLC was reported to be in complete remission after 62 days of treatment, but subsequently developed cervicallymph node recurrence and lobular breast carcinoma. Both were treated surgically and patient received antineoplaston A10; at the time of study publication, the patient was reported to have been free of both cancers for more than 4 years.
fReported at 4 years of follow-up; 10 patients had died at the time of study publication.
gPatients reported to be in complete remission more than 5 years after beginning treatment; the patient with colon cancer had undergone previous resection and was reported to have maintained complete remission during A3 treatment, however, developed recurrence with metastases after discontinuation of treatment. This patient subsequently received other antineoplaston formulations and chemotherapy.
hLength of follow-up not specified.
iReported at 2 years of follow-up; at the time of study publication, one patient was reported to have been in complete remission for 17 months and off treatment for 16 months; the other patients were reported to have been disease-free for 9 months prior to study publication and to be continuing antineoplastons but not DES.
jDiethylstilbestrol (DES)
kLength of follow-up not specified.
lSurgery, chemotherapy, radiation, and biological response modifiers (beta-interferon).
mAuthors reported on the outcome of 46 tumors for complete or partial response and provided survival information for patients.
nChemotherapy and radiation.
oSurgery, chemotherapy, radiation, and interferon.
pBoth patients had died by the time of study publication.
qChemotherapy.
rAt the time of study publication, all patients had died.
sSurgery, chemotherapy, radiation, and interferon.
tBoth patients had died by the time of study publication.
uChemotherapy.
vAt the time of study publication, all patients had died.

References

  1. Burzynski SR, Stolzmann Z, Szopa B, et al.: Antineoplaston A in cancer therapy. (I). Physiol Chem Phys 9 (6): 485-500, 1977.  [PUBMED Abstract]

  2. Burzynski SR, Kubove E: Toxicology studies on antineoplaston A10 injections in cancer patients. Drugs Exp Clin Res 12 (Suppl 1): 47-55, 1986.  [PUBMED Abstract]

  3. Burzynski SR, Burzynski B, Mohabbat MO: Toxicology studies on antineoplaston AS2-1 injections in cancer patients. Drugs Exp Clin Res 12 (Suppl 1): 25-35, 1986.  [PUBMED Abstract]

  4. Tsuda H, Sata M, Kumabe T, et al.: Quick response of advanced cancer to chemoradiation therapy with antineoplastons. Oncol Rep 5 (3): 597-600, 1998 May-Jun.  [PUBMED Abstract]

  5. Burzynski SR: Toxicology studies on antineoplaston AS2-5 injections in cancer patients. Drugs Exp Clin Res 12 (Suppl 1): 17-24, 1986.  [PUBMED Abstract]

  6. Burzynski SR, Kubove E: Phase I clinical studies of antineoplaston A3 injections. Drugs Exp Clin Res 13 (Suppl 1): 17-29, 1987.  [PUBMED Abstract]

  7. Burzynski SR, Kubove E, Burzynski B: Phase I clinical studies of antineoplaston A5 injections. Drugs Exp Clin Res 13 (Suppl 1): 37-43, 1987.  [PUBMED Abstract]

  8. Sugita Y, Tsuda H, Maruiwa H, et al.: The effect of Antineoplaston, a new antitumor agent on malignant brain tumors. Kurume Med J 42 (3): 133-40, 1995.  [PUBMED Abstract]

  9. Buckner JC, Malkin MG, Reed E, et al.: Phase II study of antineoplastons A10 (NSC 648539) and AS2-1 (NSC 620261) in patients with recurrent glioma. Mayo Clin Proc 74 (2): 137-45, 1999.  [PUBMED Abstract]

  10. Burzynski SR, Lewy RI, Weaver RA, et al.: Phase II study of antineoplaston A10 and AS2-1 in patients with recurrent diffuse intrinsic brain stem glioma: a preliminary report. Drugs R D 4 (2): 91-101, 2003.  [PUBMED Abstract]

  11. Burzynski SR, Weaver RA, Lewy RI, et al.: Phase II study of antineoplaston A10 and AS2-1 in children with recurrent and progressive multicentric glioma : a preliminary report. Drugs R D 5 (6): 315-26, 2004.  [PUBMED Abstract]

  12. Burzynski SR, Weaver RA, Janicki T, et al.: Long-term survival of high-risk pediatric patients with primitive neuroectodermal tumors treated with antineoplastons A10 and AS2-1. Integr Cancer Ther 4 (2): 168-77, 2005.  [PUBMED Abstract]

  13. Burzynski SR, Janicki TJ, Weaver RA, et al.: Targeted therapy with antineoplastons A10 and AS2-1 of high-grade, recurrent, and progressive brainstem glioma. Integr Cancer Ther 5 (1): 40-7, 2006.  [PUBMED Abstract]

  14. Burzynski SR, Kubove E, Burzynski B: Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1. Drugs Exp Clin Res 16 (7): 361-9, 1990.  [PUBMED Abstract]

  15. Kumabe T, Tsuda H, Uchida M, et al.: Antineoplaston treatment for advanced hepatocellular carcinoma. Oncol Rep 5 (6): 1363-7, 1998 Nov-Dec.  [PUBMED Abstract]

  16. Tsuda H, Hara H, Eriguchi N, et al.: Toxicological study on antineoplastons A-10 and AS2-1 in cancer patients. Kurume Med J 42 (4): 241-9, 1995.  [PUBMED Abstract]


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