Neoplasms

All Conditions

Rare Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Study subjects receive a single daily radiation fraction of 180cGy, 5 days a week for 6 weeks overall, to a total radiation dose of 5400cGy.

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for 104 weeks. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached. Study subjects also receive a single daily radiation fraction of 180cGy, 5 days a week for 6 weeks overall, to a total radiation dose of 5400cGy.

Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive radiation.

Radiation

Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation

Atengenal

Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation

Astugenal

Stanislaw R Burzynski, M.D., Ph.D.

Stanislaw R. Burzynski, MD, PhD

Patients ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma will be enrolled in this study. However, the primary objectives of this study are to 1) compare overall survival, the time from randomization to death from any cause, for study subjects 3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma who receive Antineoplaston therapy (Atengenal + Astugenal) + radiation therapy vs. radiation therapy alone and 2) describe the toxicity profile (all subjects) for Antineoplaston therapy + radiation therapy vs. radiation therapy alone.

A secondary objective is to compare progression-free survival for study subjects 3-21 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma treated with Antineoplaston therapy + radiation therapy vs. radiation therapy alone.

This is a randomized Phase 3 protocol study of Antineoplaston therapy + radiation therapy vs. radiation therapy alone in subjects ≥ 3 years of age with newly-diagnosed, diffuse, intrinsic pontine glioma. In those subjects randomized to Antineoplaston therapy + radiation therapy, Antineoplaston therapy is administered for 104 weeks while radiation therapy commences on day one of Antineoplaston therapy and continues for 6 weeks. Subjects continue on Antineoplaston therapy if an objective response or stable disease is achieved during therapy and are maintained on Antineoplaston therapy to the end of the protocol study unless they develop progressive disease. Subjects randomized to radiation therapy alone receive 6 weeks of radiation therapy.

Exploratory objectives are to compare the following in the two treatment arms: 1) overall survival for study subjects ≥ 21 years of age; 2) progression-free survival for subjects ≥ 21 years of age; 3) objective response, complete response, partial response, and progressive disease rates, based on the enhancing portion of the tumor, for all subjects, using bidimentional measurement of tumor; 4) objective response, complete response, partial response, and progressive disease rates, for all subjects with non-enhancing tumors, using unidimentional measurement of tumor; and 5) objective response, complete response, partial response, and progressive disease rates, based on the enhancing + non-enhancing portions of the tumor, for all subjects, using unidimentional measurement of tumor.

Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma

A Randomized Phase 3 Study of Combination Antineoplaston Therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] Plus Radiation Therapy vs. Radiation Therapy Only in Subjects With Newly Diagnosed Diffuse, Intrinsic, Brainstem Glioma

The Kaplan-Meier nonparametric method is used to evaluate overall survival in the two therapy groups. Survival difference is evaluated using a log-rank test, which compares the two therapy groups. A Cox proportional hazards model is used as a supportive analysis to assess the magnitude of difference between the two therapy groups. The median survival rate in the two therapy groups (and 95% confidence intervals) is evaluated. Hazard ratio and its 95% confidence interval are estimated.

The Kaplan-Meier nonparametric method is used to evaluate progression-free survival in the two therapy groups. Progression-free survival difference is evaluated using a log-rank test, which compares the two therapy groups. A Cox proportional hazards model is used as a supportive analysis to assess the magnitude of difference between the two therapy groups. The median progression-free survival rate in the two therapy groups (and 95% confidence intervals) is evaluated. Hazard ratio and its 95% confidence interval are estimated.analysis is provided.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma	NCT02887040	Brain Stem Glio...	Radiation Atengenal Astugenal	3 Years - 99 Years	Burzynski Research Institute
Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma	NCT02887040	Brain Stem Glio...	Radiation Atengenal Astugenal	3 Years - 99 Years	Burzynski Research Institute
Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma	NCT02887040	Brain Stem Glio...	Radiation Atengenal Astugenal	3 Years - 99 Years	Burzynski Research Institute

Spots Global Cancer Trial Database for diffuse, intrinsic brain stem glioma