|
Single-Antineoplaston Therapy
|
| [1]B*
|
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]B* |
Various 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]B* |
Various advanced cancers (23) |
A3
|
Highest dose: 76 mg/kg/24 h |
|
44–478 d
|
| [8]B* |
Various advanced cancers (15) |
A5 |
Highest dose range: 44 to 154 mg/kg/24 h |
IV: daily divided doses |
47–130 d |
| [2]B* |
Various advanced cancers (18) |
A10 |
Highest 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 h |
IV: every 6 h |
38–872 d |
| [5] |
Various advanced cancers |
AS2-5 |
Highest dose: 167.6 mg/kg/24 h |
IV: daily divided doses |
41–436 d |
|
Combinations
|
| [17]B* |
Hormonally refractive prostate (14) |
AS2-1 and DES |
AS2-1 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/A10 |
Highest dose range: 7 to 10 g/d |
Oral and IV |
|
| [18] |
Hepatocellular (3) |
AS2-1/A10 (1 patient) |
3 to 10 g/d |
IV |
7–120 d (approx)
|
| [10] |
Recurrent glioma (9) |
A10/AS2-1 |
Target dose: A10: 1.0 g/kg/24 h; AS2-1: 0.4 g/kg/24 h. |
IV: daily divided doses |
9–66 d |
| Steady-state plasma concentrations at target dose: phenylacetate, 177 ± 101 μg/mL; phenylacetylglutamine: 301 ± 102 μg/mL |
| [13]B* |
Pediatric recurrent progressive multicentric glioma (11) |
A10/AS2-1 |
Formation 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]B* |
Recurrent diffuse intrinsic brain stem glioma (12) |
A10/AS2-1 |
Formulation 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]B* |
Primitive neuroectodermal tumor (13) |
A10/AS2-1 |
Formulation 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]B* |
Recurrent diffuse intrinsic brain stem glioma |
A10/AS2-1 |
Average max dose: A10: 13.37g/kg/d; AS2-1: 0.49 g/kg/d |
IV injection of gradually increasing dose until max dose is reached. |
Average 5 mo |
