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

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.

Table 2. Antineoplastons Clinical Trials

Reference CitationsType of StudyType(s) of AntineoplastonType(s) of CancerNo. of PatientsStrongest Benefit ReportedConcurrent Therapy
No. = number; pt/pts = patient/patients.
a Reported at 9 months of follow-up; patient with breast cancer had undergone radicalmastectomy, radiation therapy, and chemotherapy and had subsequent metastases to ribs surgicallyresectedprior to treatment with antineoplastons.
b One patient with bladder cancer hadsurgeryfor removal of necrotic tumor.
c Reported at 5 years of follow-up; patient withstage IA cervical cancerreceived prior radiation therapy; patient with breast cancer received prior radical mastectomy and had nomeasurable diseaseat the initiation of antineoplaston treatment.
d One patient received 5-fluorouracil.
e Reported at 5 years of follow-up; patient withstage II laryngeal cancerwas 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 developedcervical lymph noderecurrence 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.
f Reported at 4 years of follow-up; 10 patients had died at the time of study publication.
g Patients reported to be in complete remission more than 5 years after beginning treatment; the patient withcolon cancerhad 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.
h Length of follow-up not specified.
i Reported 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.
j Diethylstilbestrol (DES)
k Length of follow-up not specified.
l Surgery, chemotherapy, radiation, andbiological response modifiers(beta-interferon).
m Authors reported on theoutcomeof 46 tumors for complete or partial response and provided survival information for patients.
n Chemotherapy and radiation.
o Surgery, chemotherapy, radiation, and interferon.
p Both patients had died by the time of study publication.
q Chemotherapy.
r At the time of study publication, all patients had died.
s Surgery, chemotherapy, radiation, and interferon.
t Both patients had died by the time of study publication.
u Chemotherapy.
v At the time of study publication, all patients had died.
[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)cNod
AS2-1 plus other antineoplaston formulations (12 pts)
[5]Nonconsecutive case seriesAS2-5 (11 pts)Various types, advanced stages13Complete remission (stage IIlaryngeal,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 cellepithelioma, andcoloncancer)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 tumorthrombusin theportal 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
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