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Antineoplastons (PDQ®)
Patient Version   Health Professional Version   Last Modified: 04/24/2008



Purpose of This PDQ Summary






Overview






General Information






History






Laboratory/Animal/Preclinical Studies






Human/Clinical Studies






Adverse Effects






Overall Level of Evidence for Antineoplastons






Changes to This Summary (04/24/2008)






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Adverse Effects

Adverse effects of antineoplaston therapy have ranged from mild and short-lasting symptoms to severe neurologic toxicity necessitating discontinuation of therapy in some patients.[1]

Table 3 summarizes the adverse effects in the referenced studies.

Table 3. Adverse Effects
Adverse Effect  Reference 
*The most severe adverse effects occurred in this study, which reported neurologic toxic effects such as excessive somnolence, somnolence plus confusion, and increased frequency of underlying focalmotorseizures; increased cerebral edema; and persistent confusion. In addition, the study reported myalgia, severe cutaneouserythema, pruritus, and anasarca of the extremities and face.
Anemia [2,3]
Blood pressure elevation [4,5]
Dizziness or vertigo [6,7]
Excess abdominal gas [4,8]
Fever and chills [2,5-7,9-11]
General malaise with and without anorexia [2,4]
Headaches [1,4,6,7]
Hypocalcemia and hypercalcemia [2,5]
Increased thickness of epidermis associated with skin peeling and faster-than-usual growth of nails [11]
Maculopapular or itchy skin rash [2,4,5,8]
Mild myelosuppression [5,8,12]
Nausea and vomiting [1,2,5-7]
Neurocortical toxicity, severe [1]*
Numbness [2]
Palpitations, tachycardia, or pressure in the chest with irregular heartbeat [4,11,1,7]
Peripheral edema, facial edema, cerebral edema [1,4]
Swelling, pain, or stiffness of small joints [4,8,10,11]

References

  1. 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]

  2. 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]

  3. 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]

  4. 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]

  5. 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]

  6. 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]

  7. Burzynski SR, Kubove E: Phase I clinical studies of antineoplaston A3 injections. Drugs Exp Clin Res 13 (Suppl 1): 17-29, 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. Burzynski SR, Stolzmann Z, Szopa B, et al.: Antineoplaston A in cancer therapy. (I). Physiol Chem Phys 9 (6): 485-500, 1977.  [PUBMED Abstract]

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

  11. 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]

  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]

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