Table 1. Dose Ranges for Clinical Studies of Antineoplastons

Reference Cancer Types (No. Patients) Antineoplaston Dose Administration Treatment Duration
Single-Antineoplaston Therapy
[1]Ba Various advanced cancers or leukemia (12) A A was measured in units, the amount of preparation A that produces a cytostatic effect in 100 mL of 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 infusion of 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)A2 Highest 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)A3 Highest 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 h IV: 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 cancers AS2-1 Highest 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 refractive prostate (14)AS2-1 and DESAS2-1 dose range: 97 to 130 mg/kg/24 h Oral 64–425 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/AS2-1Formulation dose: A10: 300 mg/mL; AS2-1: 80 mg/mL A10 and AS2-1 IV injection gradually increasing dose until max dose is reached. Oral administration by capsules followed.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/mL IV 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/mL IV 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

bi-wk = bi-weekly; d = day; DES = diethylstilbestrol; h = hour; IM = intramuscular; IV = intravenous; mo = month; No. = number; U = unit; wk = week.

aB indicates a study by Burzynski and associates.

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