Antineoplaston Therapy in Treating Patients With Brain Stem Glioma

Phase 2

Completed

• Conditions: Brain Stem Gliomas
• Interventions: Drug: Antineoplaston therapy (Atengenal + Astugenal)

• Registration Number: NCT00003459
• Lead Sponsor: Burzynski Research Institute

Brief 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.

Study Timeline

• Study Start: 1996-03
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2016-05-25
• Results First Submitted QC: 2016-08-18
• Results First Posted: 2016-10-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-11
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antineoplaston therapy	Antineoplaston therapy (Atengenal + Astugenal)	Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Objective Response	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Survived	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

Trial Locations

Locations (1)

Burzynski Clinic; 🇺🇸 Houston, Texas, United States