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Antineoplastons (PDQ®): Complementary and alternative medicine - Health Professional Information [NCI] - Human / Clinical Studies

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Hepatocellular (liver) cancer

A case report from Japan discussed two patients with advanced hepatocellular carcinoma who received antineoplaston A10 in addition to other treatments. Although both patients died—one from hemorrhagic pancreatic necroses and the other from hepatic failure brought on by esophageal varices—both appeared to tolerate A10 with few serious side effects. CT scans indicated that one patient exhibited inhibition of tumor growth and slight shrinkage of the tumor after oral administration and infusion of A10.[18]

To date, no randomized controlled trials examining the use of antineoplastons in patients with cancer have been reported in the literature. Existing publications have taken the form of case reports or series, phase I clinical trials, and phase II clinical trials, conducted mainly by the developer and his associates. While these publications have reported on successful remissions with the use of antineoplastons, other investigators have been unable to duplicate these results [10] and suggest that interpreting effects of antineoplaston treatment in patients with recurrent gliomas may be confounded by pre-antineoplaston treatment as well as imaging artifacts.[11,14,16] Reports originating from Japan on the effect of antineoplaston treatment on brain and other types of tumors have been mixed, and in some Japanese studies the specific antineoplastons used are not named.[9] In many of the reported studies, several or all patients received concurrent or recent radiation therapy, chemotherapy, or both, confounding interpretability.

Table 1 summarizes the dose ranges of antineoplastons used in the studies discussed above.

Table 1. Dose Ranges for Clinical Studies of Antineoplastons

ReferenceCancer Types (No. Patients)AntineoplastonDoseAdministrationTreatment Duration
bi-wk = bi-weekly; d = day; h = hour; IM = intramuscular; IV = intravenous; mo = month; No. = number; U = unit; wk = week.
a B indicates a study by Burzynski and associates.
Single-Antineoplaston Therapy
[1]BaVarious advanced cancers or leukemia (12)AA was measured in units, the amount of preparation A that produces a cytostatic effect in 100mLof breast cancer cell line MDA-MB-231 determined by the stable number of cells counted after 24 h of incubation and persisting for at least an additional 48 h. Dose differed by type of administration.IV: Range from 0.6 U/m²/24 h to 33 U/m²/24 h daily for 1 mo. IM: Range from 0.6 U/m²/24 h to 20 U/m²/24 h for up to 8 mo bi-wk. Rectal: Range from 15 U/m²/24 h to 23 U/m²/24 h daily divided into 2 or 3 doses/12–8 h post–IM treatment. Bladder instillation:Continuous infusionof 2.3 U/m²/24 h for 3 wk. Intrapleurally: 2 U to 4 U/injection. Highest tolerated dose: IV: 33 U/m²/24 h after initial febrile reaction subsided. IM: 10 U/m²/24 h.IV: 1 mo; IM: bi-wk for up to 8 wk Rectal: daily Bladder Instillation: 3 wk Intrapleural: once/wk
[6]BaVarious advanced cancers (15)A2Highest dose: 147 mg/kg/24 h (A2 formulations: 50 mg/mL and 100 mg/mL)IV: daily divided doses every 6 h or every 12 h.52–358 d
[7]BaVarious advanced cancers (23)A3Highest dose: 76 mg/kg/24 h 44–478 d
[8]BaVarious advanced cancers (15)A5Highest dose range: 44 to 154 mg/kg/24 hIV: daily divided doses47–130 d
[2]BaVarious advanced cancers (18)A10Highest dose range: 70.0 to 2,210.5 mg/kg/24 hIV: gradual increase every 3–6 h from 100 mg/mL to highest dose.52–640 d
Typical dose range: 206.9 to 387 mg/kg/24 h
[3]Various advanced cancersAS2-1Highest dose: 160 mg/kg/24 hIV: every 6 h38–872 d
[5]Various advanced cancersAS2-5Highest dose: 167.6 mg/kg/24 hIV: daily divided doses41–436 d
Combinations
[17]BaHormonally refractiveprostate(14)AS2-1 and DESAS2-1 dose range: 97 to 130 mg/kg/24 hOral64–425 d
DES dose range: 0.01 to 0.02 mg/kg/24 h
[9]Various brain tumors (9)AS2-1/A10Highest dose range: 7 to 10 g/dOral and IV 
[18]Hepatocellular (3)AS2-1/A10 (1 patient)3 to 10 g/dIV7–120 d (approx)
[10]Recurrent glioma (9)A10/AS2-1Target dose: A10: 1.0 g/kg/24 h; AS2-1: 0.4 g/kg/24 h.IV: daily divided doses9–66 d
Steady-state plasma concentrations at target dose: phenylacetate, 177 ± 101 μg/mL; phenylacetylglutamine: 301 ± 102 μg/mL
[13]BaPediatric recurrent progressive multicentric glioma (11)A10/AS2-1Formation dose: A10: 300 mg/mL; AS2-1: 80 mg/mL A10 and AS2-1IV injection gradually increasing dose until max dose is reached. Oral administration bycapsulesfollowed.IV: Average 16 mo; Oral: 19 mo
Max dose range: A10: 5.29 g/kg/d to 16.13 g/kg/d
Max dose range: AS2-1: 0.21 g/kg/d to 0.58 g/kg/d
[12]BaRecurrent diffuse intrinsic brain stem glioma (12)A10/AS2-1Formulation dose: A10: 300 mg/mL; AS2-1: 80 mg/mLIV injection of gradually increasing dose until max dose is reached.Average 6 mo
A10 max dose range: 5.29 g/kg/d to 16.13 g/kg/d
AS2-1 max dose range: 0.21 g/kg/d to 0.58 g/kg/d
[14]BaPrimitive neuroectodermal tumor (13)A10/AS2-1Formulation dose: A10: 300 mg/mL; AS2-1: 80 mg/mLIV injection of gradually increasing dose until max dose is reached.Average 20 mo
Average dose: A10: 10.3 g/kg/d; AS2-1: 0.38 g/kg/d
Max dose: A10: 25 g/kg/d; AS2-1: 0.6 g/kg/d
[16]BaRecurrent diffuse intrinsic brain stem gliomaA10/AS2-1Average max dose: A10: 13.37g/kg/d; AS2-1: 0.49 g/kg/dIV injection of gradually increasing dose until max dose is reached.Average 5 mo

Table 2 summarizes the clinical trials used in the studies discussed above.

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WebMD Public Information from the National Cancer Institute

Last Updated: February 25, 2014
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