NCT00003459

Antineoplaston Therapy in Treating Patients With Brain Stem Glioma

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Stem Glioma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: All
• Age: 6 Months – 99 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Current therapies for a brain stem glioma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children (\> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.

Detailed description

OBJECTIVES: * To determine the efficacy of Antineoplaston therapy in patients with a brain stem glioma, 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 patients with a brain stem glioma. OVERVIEW: This is a single arm, open-label study in which patients 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 in measured utilizing MRI scans, which are performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years, every 6 months for the 5th and 6th years, and annually thereafter. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Conditions

• Brain Stem Gliomas

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)

Timeline

• Start date: 1996-03-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2003-01-27
• Last updated: 2018-03-14
• Results posted: 2016-10-12

Locations

1 site across 1 country: United States