Antineoplaston Therapy in Treating Patients With Brain Tumors
Phase II Study Of Antineoplastons A10 And AS2-1 In Patients With Brain Tumors.
Sponsor: Burzynski Research Institute
A PHASE2 clinical study on Refractory Brain Tumors, this trial is completed. The trial is conducted by Burzynski Research Institute and has accumulated 7 data snapshots since 1996. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors 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 adults with persistent or recurrent brain tumors.
OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent 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. 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: A total of 20-40 patients will be accrued to this study
OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in adults with persistent or recurrent brain tumors 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 adults with persistent or recurrent brain tumors.
OVERVIEW: This is a single arm, open-label study in which adults with persistent or recurrent 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. 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: A total of 20-40 patients will be accrued to this study
Status Flow
Change History
7 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2
-
Sep 2024 — Present [monthly]
Completed PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE2
▶ Show 2 earlier versions
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2
First recorded
Jul 1996
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Burzynski Research Institute
For direct contact, visit the study record on ClinicalTrials.gov .