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The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma.

Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A - Childs Nerv Syst (2014)

Bottom Line: He was disconnected from the ventilator and died from brain tumor according to the attending physician.Responding patients experienced improved quality of life.The results suggest that ANP shows efficacy and acceptable tolerability profile in patients with RPDIPG.

View Article: PubMed Central - PubMed

Affiliation: Burzynski Clinic, 9432 Katy Freeway, Houston, TX, 77055, USA.

ABSTRACT

Background: Brainstem gliomas (BSG) are relatively rare tumors of which recurrent pediatric diffuse intrinsic pontine gliomas (RPDIPG) comprise a distinct group. Numerous trials have been conducted on RPDIPG, none of which have resulted in identifying any proven pharmacological treatment benefit. This study included 40 patients diagnosed with different types of BSG, but it was decided to describe first the encouraging results in the most challenging group of RPDIPG.

Materials and methods: This single-arm phase II study evaluated the efficacy and safety of the combination of antineoplastons A10 and AS2-1 (ANP) in patients with RPDIPG. Seventeen patients (median age 8.8 years) were enrolled, and all were diagnosed with RPDIPG. ANP was administered intravenously daily. Efficacy analyses were conducted in this group of patients.

Results: In this group, complete responses were observed in 6 % of patients, partial responses in 23.5 %, and stable disease in 11.8 %. Six-month progression-free survival was 35.3 %. One-year overall survival was 29.4 %, 2 years 11.8 %, and 5, 10, and 15 years 5.9 %. One patient with DIPG is alive over 15 years post-treatment. Grade 3 and higher toxicities including hypokalemia and fatigue occurred in 6 %, hypernatremia in 18 %, fatigue and urinary incontinence in 6 %, and somnolence in 12 %. In a single patient, grade 4 hypernatremia occurred when he was on mechanical ventilation. He was disconnected from the ventilator and died from brain tumor according to the attending physician. Responding patients experienced improved quality of life.

Conclusion: The results suggest that ANP shows efficacy and acceptable tolerability profile in patients with RPDIPG.

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Related in: MedlinePlus

DIPG in a 10-year-old male (case 8) which recurred two times after partial surgical resection. MRI of the head: 1—T1 nonenhanced, 2—contrast-enhanced, 3—T2W, and 4—FLAIR images. PR was documented by the MRI and CR was established by the normalization of the follow-up PET scans. Arrows indicate tumors
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Fig2: DIPG in a 10-year-old male (case 8) which recurred two times after partial surgical resection. MRI of the head: 1—T1 nonenhanced, 2—contrast-enhanced, 3—T2W, and 4—FLAIR images. PR was documented by the MRI and CR was established by the normalization of the follow-up PET scans. Arrows indicate tumors

Mentions: In the group of 17 RPDIPG patients, there were five cases of OR (29.5 %): one CR (6 %) and 4 PR (23.5 %). An additional group of two patients (11.8 %) had stabilization of their disease, eight patients (47 %) developed progressive disease, and two cases (12 %) were nonevaluable (NE). Figures 2 and 3 illustrate the response to treatment with ANP in two patients.Fig. 2


The response and survival of children with recurrent diffuse intrinsic pontine glioma based on phase II study of antineoplastons A10 and AS2-1 in patients with brainstem glioma.

Burzynski SR, Janicki TJ, Burzynski GS, Marszalek A - Childs Nerv Syst (2014)

DIPG in a 10-year-old male (case 8) which recurred two times after partial surgical resection. MRI of the head: 1—T1 nonenhanced, 2—contrast-enhanced, 3—T2W, and 4—FLAIR images. PR was documented by the MRI and CR was established by the normalization of the follow-up PET scans. Arrows indicate tumors
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4223571&req=5

Fig2: DIPG in a 10-year-old male (case 8) which recurred two times after partial surgical resection. MRI of the head: 1—T1 nonenhanced, 2—contrast-enhanced, 3—T2W, and 4—FLAIR images. PR was documented by the MRI and CR was established by the normalization of the follow-up PET scans. Arrows indicate tumors
Mentions: In the group of 17 RPDIPG patients, there were five cases of OR (29.5 %): one CR (6 %) and 4 PR (23.5 %). An additional group of two patients (11.8 %) had stabilization of their disease, eight patients (47 %) developed progressive disease, and two cases (12 %) were nonevaluable (NE). Figures 2 and 3 illustrate the response to treatment with ANP in two patients.Fig. 2

Bottom Line: He was disconnected from the ventilator and died from brain tumor according to the attending physician.Responding patients experienced improved quality of life.The results suggest that ANP shows efficacy and acceptable tolerability profile in patients with RPDIPG.

View Article: PubMed Central - PubMed

Affiliation: Burzynski Clinic, 9432 Katy Freeway, Houston, TX, 77055, USA.

ABSTRACT

Background: Brainstem gliomas (BSG) are relatively rare tumors of which recurrent pediatric diffuse intrinsic pontine gliomas (RPDIPG) comprise a distinct group. Numerous trials have been conducted on RPDIPG, none of which have resulted in identifying any proven pharmacological treatment benefit. This study included 40 patients diagnosed with different types of BSG, but it was decided to describe first the encouraging results in the most challenging group of RPDIPG.

Materials and methods: This single-arm phase II study evaluated the efficacy and safety of the combination of antineoplastons A10 and AS2-1 (ANP) in patients with RPDIPG. Seventeen patients (median age 8.8 years) were enrolled, and all were diagnosed with RPDIPG. ANP was administered intravenously daily. Efficacy analyses were conducted in this group of patients.

Results: In this group, complete responses were observed in 6 % of patients, partial responses in 23.5 %, and stable disease in 11.8 %. Six-month progression-free survival was 35.3 %. One-year overall survival was 29.4 %, 2 years 11.8 %, and 5, 10, and 15 years 5.9 %. One patient with DIPG is alive over 15 years post-treatment. Grade 3 and higher toxicities including hypokalemia and fatigue occurred in 6 %, hypernatremia in 18 %, fatigue and urinary incontinence in 6 %, and somnolence in 12 %. In a single patient, grade 4 hypernatremia occurred when he was on mechanical ventilation. He was disconnected from the ventilator and died from brain tumor according to the attending physician. Responding patients experienced improved quality of life.

Conclusion: The results suggest that ANP shows efficacy and acceptable tolerability profile in patients with RPDIPG.

Show MeSH
Related in: MedlinePlus