Clinical Trial: Antineoplaston Therapy in Treating Children With Brain Tumors

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

Official Title: Phase II Study of Antineoplastons A10 and AS2-1 in Children With Brain Tumors

Brief Summary:

RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of childhood brain tumors.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (> 6 months of age) with brain tumors.


Detailed Summary:

OVERVIEW: This is a single arm, open-label study in which children with brain tumors 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.

OBJECTIVES:

  • To determine the efficacy of Antineoplaston therapy in children with a brain tumor, 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 a brain tumor.
  • 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: A total of 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.


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: September 1996
Date Completion:
Last Updated: January 29, 2017
Last Verified: January 2017