The Present State of Antineoplaston Research (1)

Janicki

2017

CCO

Self Cite

Protocol BT-23, a Phase II study, was performed to determine the efficacy and safety of combination Antineoplaston A10 and Antineoplaston AS2-1 (ANP) in children with an optic pathway glioma (OPG). Sixteen patients (12 males, 4 females) ages 1 to 16 years (median age 4.5 years) were treated. The patients received ANP, by intravenous infusion, six times daily (i.e., every four hours). The length of treatment extended from a minimum of 4.1 weeks to a maximum of 210.0 weeks. The median dosage of A10 was 8.07 g/kg/d while for AS2-1 it was 0.39 g/kg/d.Patients' best response to ANP was determined: 12.5% of this patient population achieved a complete response, 18.8% achieved a partial response, and 31.3% maintained stable disease. The median overall survival was 78.5 months (95% CI: 37.6-92.3) while median progression-free survival was 45.4 months (95% CI: 7.1-71.4). ANP was associated with a 12% incidence of Grade 3 and a 12% incidence of Grade 4 adverse drug experiences (ADEs). There were no Grade 5 ADEs. Grade 3 ADEs included somnolence and elevated SGOT; Grade 4 ADEs included hypernatremia and hypokalemia. Long-term quality of life was excellent with no chronic toxicity identified. Children with an OPG respond very well to ANP with good efficacy and toxicity profiles.

Section: Administration Of the Medicationsmentioning

confidence: 99%

“…Chronic toxicity continues to be a major problem (Burzynski, 2006). Antineoplastons A10 and AS2-1 are synthetic derivatives of glutamine, isoglutamine, and phenylacetic acid (Burzynski, 2004). A10 is a synthetic formulation consisting of a 4:1 ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (isoPG).…”

Section: Introductionmentioning

confidence: 99%

Antineoplastons A10 and AS2-1 in the Treatment of Children with Optic Pathway Glioma: Final Report for Protocol BT-23

Janicki

2017

CCO

Self Cite

“…Subsequent studies concentrated on different subgroups of pediatric brain tumors including brainstem glioma (BSG), LGA, optic pathway glioma (OPG), recurrent primitive neuroectodermal tumor (PNET), atypical teratoid/rhabdoid tumor (AT/RT), ependymoma, choroid plexus carcinoma, and craniopharyngioma (CP) [9]- [17]. The interim results on some of these trials have been published [6]- [17].…”

Section: Introductionmentioning

confidence: 99%

“…A10 consists of a 4:1 ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate sodium (isoPG). AS2-1 consists of a 4:1 ratio of phenylacetate sodium (PN and PG) [5] [6]. Initial clinical responses in the treatment of pediatric brain tumors led to the design and implementation of a series of clinical studies to evaluate the safety and efficacy of ANP [7].…”

Section: Introductionmentioning

confidence: 99%

A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Brain Tumors. Final Report (Protocol BT-10)

Burzynski¹,

Janicki²,

Burzynski³

et al. 2017

JCT

Self Cite

Despite dramatic progress over the last 50 years in the treatment of many childhood cancers, primary brain tumors remain the leading cause of death in pediatric oncology. This phase II study evaluated the efficacy and safety of Antineoplastons A10 and AS2-1 given in combination (ANP). Thirty-four patients, with a median age of 10.4 years, were enrolled in the study. Thirty-two patients (94.1%), were Caucasians while 21 (61.8%) were female and 13 were male (38.2%). Twenty-four patients (70.6%) suffered from a brainstem glioma (BSG) or high-grade tumor. Ten patients (29.4%) suffered from a low-grade tumor. A distinct sub-group of three patients with low grade tumors had a ganglioglioma (GG). Eighty-two percent of patients had failed standard treatment. Daily ANP was administered by IV infusion, every four hours, until an objective response (OR) was documented, and then for an additional eight months. The median doses of A10 and AS2-1 were 11.64 g/kg/d and 0.45 g/kg/d, respectively. A complete response (CR) was documented in two patients (5.9%), a partial response (PR) in four patients (11.8%), and stable disease (SD) in six patients (17.6%). Objective responses were observed in diffuse intrinsic pontine glioma (DIPG), thalamic pilocytic astrocytoma with brainstem involvement, ganglioglioma and pilocytic astrocytoma. Six-month progression-free survival (PFS) was 35.3%. Overall survival (OS) at two and five years was 37.6% and 34.5%, respectively. Two patients experienced grade 4 hypernatremia while three experienced grade 3 hypokalemia. In this group of patients, ANP showed good efficacy and an acceptable toxicity profile.

“…Antineoplastons A10 and AS2-1 (ANP) are synthetic derivatives of glutamine, isoglutamine, and phenylacetic acid (Burzynski, 2004). A10 is a synthetic formulation consisting of a 4:1 ratio of phenylacetylglutaminate sodium (PG) and phenylacetylisoglutaminate (isoPG).…”

Section: Introductionmentioning

confidence: 99%

Primary CNS Tumors and Leptomeningeal, Disseminated and/or Multicentric Disease in Children Treated in Phase II Studies with Antineoplastons A10 and AS2-1

Burzynski¹,

Janicki²,

Burzynski³

2016

CCO

It is estimated that as many as 30% of patients with primary CNS tumors have leptomeningeal, disseminated, and/or multicentric disease (LDM). These patients respond poorly to conventional therapy. Fifty-seven children with LDM (median age of 7.1 years) were treated in multiple prospective phase II clinical studies of high-and low-grade primary CNS tumors with Antineoplastons A10 and AS2-1 (ANP). Their inclusion in this analysis was based on MRI imaging. Patients with glioblastoma were excluded. The patients received ANP therapy 6 times daily; A10: 8.77 g/kg/d; AS2-1: 0.35 g/kg/d. The response to ANP was monitored by MRIs every 8 weeks.Patients evaluable for efficacy (N = 40) received 12 or more weeks of ANP or developed progressive disease (PD) before 12 weeks. 10 patients (17.5%) achieved an objective response (OR) with 4 (7%) achieving a complete response (CR) and 6 (10.5%) had a partial response (PR). Stable disease (SD) was maintained in 7 patients (12.3%) and PD developed in 23 patients (40.4%). Survival analysis of the 57 children showed 2-and 5-year overall survival (OS) were both 28% while 10-and 15-year OS were both 26%. One of the patients achieving an OR had atypical teratoid/rhabdoid tumor (AT/RT) while nine had low-grade gliomas (LGGs). Grade 3 and 4 toxicities included hypokalemia (14.0%); fatigue, anemia, hypernatremia and leukopenia (3.5% each); diarrhea, hypertension, joint pain, thrombocytopenia, and somnolence (1.8% each). These findings suggest the need for a single-arm, phase II study of ANP in children with LDM.