Clinical Trial: Antineoplaston Therapy in Treating Children With Visual Pathway Glioma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 Infusions in Children With Visual Pathway Glioma

Brief Summary:

RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.


Detailed Summary:

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
  • To determine the safety and tolerance of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

OVERVIEW: This is a single arm, open-label study in which children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued to this study.


Sponsor: Burzynski Research Institute

Current Primary Outcome: Number of Participants With Objective Response [ Time Frame: 12 months ]

Objective response rate per Response Assessment in Neuro-Oncology (RANO) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all disease sustained for at least four weeks; Partial Response (PR), >=50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions, sustained for at least four weeks. Stable Disease (SD): <50% decrease in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions and no Progressive Disease, sustained for at least four weeks. Progressive Disease (PD): >=25% increase in the sum of the products of of the greatest perpendicular diameters of all measurable enhancing lesions.


Original Primary Outcome:

Current Secondary Outcome: Percentage of Participants Who Survived [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, 60 months ]

6 months, 12 months, 24 months, 36 months, 48 months, 60 months overall survival


Original Secondary Outcome:

Information By: Burzynski Research Institute

Dates:
Date Received: November 1, 1999
Date Started: June 1996
Date Completion:
Last Updated: October 25, 2016
Last Verified: October 2016