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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

    Reference Cancer Types (No. Patients) Antineoplaston Dose Administration Treatment 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]Ba Various advanced cancers or leukemia (12) A A 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]Ba 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]Ba Various advanced cancers (23) A3 Highest dose: 76 mg/kg/24 h 44-478 d
    [8]Ba Various advanced cancers (15) A5 Highest dose range: 44 to 154 mg/kg/24 h IV: daily divided doses 47-130 d
    [2]Ba 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]Ba Hormonally refractiveprostate(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]Ba 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 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]Ba 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]Ba 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]Ba 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

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

    Table 2. Antineoplastons Clinical Trials

    Reference Citations Type of Study Type(s) of Antineoplaston Type(s) of Cancer No. of Patients Strongest Benefit Reported Concurrent 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 series A Various types 21 Complete remission (2 grade III bladder cancers,stage IV breast cancer, ALL)a Nob
    [3] Nonconsecutive case series AS2-1 (8 pts) Various types, most in advanced stages 20 Complete remission (stage IA cervical, intraductal breast carcinoma, stage IV lymphocytic lymphoma)c Nod
    AS2-1 plus other antineoplaston formulations (12 pts)
    [5] Nonconsecutive case series AS2-5 (11 pts) Various types, advanced stages 13 Complete remission (stage IIlaryngeal,stage III NSCLC)e No
    AS2-5 plus AS2-1 (2 pts)
    [2] Nonconsecutive case series A10 (12 pts) Various types, most in advanced stages 18 Partial remission (one case stage IB chondrosarcoma)f No
    A10 plus other antineoplaston formulations (6 pts)
    [7] Nonconsecutive case series A3 Various types, advanced stages 24 Complete remission (bladder carcinoma,basal cellepithelioma, andcoloncancer)g No
    [8] Nonconsecutive case series A5 Various types, advanced stages 15 Complete remission (grade III mixed bladder cancer)h Not specified
    [17] Consecutive case series(phase II trial) AS2-1 Prostate cancer, hormone refractory (13 stage IV, 1 stage II) 14 Complete remission (2 pts)i Yesj
    [9] Nonconsecutive case series/case reports AS2-1, A10 Brain tumors 9 Partial response (1 pontine glioma, 1 metastatic brain tumor)k Yesl
    [19] Phase I clinical trial A10, AS2-1 (randomly chosen) Various types, advanced stages 42m Complete response (3 tumors)k Yesn
    [4] Case reports A10, AS2-1 Various types 3 Reduction in tumor size (stage IV breast, stage IIIB NSCLC) Yeso
    [18] Case reports A10, AS2-1 Advanced hepatocellular carcinoma 2 Slight shrinkage of tumorthrombusin theportal vein p Yesq
    [10] Phase II clinical trial A10, AS2-1 Recurrent brain tumor (anaplastic astrocytoma or glioblastoma multiforme) 9 (6 pts were assessable for efficacy) Noner No
    [13] Phase II study A10, AS2-1 Recurrent and progressive multicentric glioma in children 12 Complete response 2 No
    Nonevaluable 1
    [12] Phase II study A10, AS2-1 Recurrent diffuse intrinsic brain stem glioma 12 Complete response 2 No
    [4] Case reports A10, AS2-1 Various types 3 Reduction in tumor size (stage IV breast, stage IIIB NSCLC) Yess
    [18] Case reports A10, AS2-1 Advanced hepatocellular carcinoma 2 Slight shrinkage of tumor thrombus in the portal veint Yesu
    [10] Phase II clinical trial A10, AS2-1 Recurrent brain tumor (anaplastic astrocytoma or glioblastoma multiforme) 9 (6 assessable for efficacy) Nonev No
    [13] Phase II study A10, AS2-1 Recurrent and progressive multicentric glioma in children 12 Complete response 2 No
    Nonevaluable 1
    [12] Phase II study A10, AS2-1 Recurrent diffuse intrinsic brain stem glioma 12 Complete response 2 No
    [14] Phase II study A10, AS2-1 Primitive neuroectodermal tumor 13 Complete response 3 No
    [16] Summary of data, phase II trials A10, AS2-1 Recurrent diffuse intrinsic brainstem glioma 18 (2 previously reported in[13]) Complete response 1 (1 previously reported) No
    1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11
    1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11
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