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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 seriesAVarious types21Complete remission (2 grade III bladder cancers, stage IV breast cancer, ALL)aNob
[3]Nonconsecutive case seriesAS2-1 (8 pts)Various types, most in advanced stages20Complete remission (stage IA cervical, intraductal breast carcinoma, stage IV lymphocytic lymphoma)c Nod
AS2-1 plus other antineoplaston formulations (12 pts)
[5]Nonconsecutive case seriesAS2-5 (11 pts)Various types, advanced stages13Complete remission (stage II laryngeal, stage III NSCLC)eNo
AS2-5 plus AS2-1 (2 pts)
[2]Nonconsecutive case seriesA10 (12 pts)Various types, most in advanced stages18Partial remission (one case stage IB chondrosarcoma)fNo
A10 plus other antineoplaston formulations (6 pts)
[7]Nonconsecutive case seriesA3Various types, advanced stages24Complete remission (bladder carcinoma, basal cell epithelioma, and colon cancer)gNo
[8]Nonconsecutive case seriesA5Various types, advanced stages15Complete remission (grade III mixed bladder cancer)hNot specified
[17]Consecutive case series (phase II trial)AS2-1Prostate cancer, hormone refractory (13 stage IV, 1 stage II)14Complete remission (2 pts)iYesj
[9]Nonconsecutive case series/case reportsAS2-1, A10Brain tumors9Partial response (1 pontine glioma, 1 metastatic brain tumor)kYesl
[19]Phase I clinical trialA10, AS2-1 (randomly chosen)Various types, advanced stages42mComplete response (3 tumors)kYesn
[4]Case reportsA10, AS2-1Various types3Reduction in tumor size (stage IV breast, stage IIIB NSCLC)Yeso
[18]Case reportsA10, AS2-1Advanced hepatocellular carcinoma2Slight shrinkage of tumor thrombus in the portal vein pYesq
[10]Phase II clinical trialA10, AS2-1Recurrent brain tumor (anaplastic astrocytoma or glioblastoma multiforme)9 (6 pts were assessable for efficacy)NonerNo
[13]Phase II studyA10, AS2-1Recurrent and progressive multicentric glioma in children12Complete response 2No
Nonevaluable 1
[12]Phase II studyA10, AS2-1Recurrent diffuse intrinsic brain stem glioma12Complete response 2No
[4]Case reportsA10, AS2-1Various types3Reduction in tumor size (stage IV breast, stage IIIB NSCLC)Yess
[18]Case reportsA10, AS2-1Advanced hepatocellular carcinoma2Slight shrinkage of tumor thrombus in the portal veintYesu
[10]Phase II clinical trialA10, AS2-1Recurrent brain tumor (anaplastic astrocytoma or glioblastoma multiforme)9 (6 assessable for efficacy)NonevNo
[13]Phase II studyA10, AS2-1Recurrent and progressive multicentric glioma in children12Complete response 2No
Nonevaluable 1
[12]Phase II studyA10, AS2-1Recurrent diffuse intrinsic brain stem glioma12Complete response 2No
[14]Phase II studyA10, AS2-1Primitive neuroectodermal tumor13Complete response 3No
[16]Summary of data, phase II trialsA10, AS2-1Recurrent diffuse intrinsic brainstem glioma18 (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]