Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Bladder
Sponsor: Burzynski Research Institute
Terminated
slow enrollment
Listed as NCT00003452, this PHASE2 trial focuses on Stage IV Bladder Cancer and remains terminated or withdrawn. Sponsored by Burzynski Research Institute, it has been updated 8 times since 1996, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)Stage IV bladder cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in patients with Stage IV bladder cancer, 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 Stage IV bladder cancer.
* 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.
Stage IV bladder cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity.
OBJECTIVES:
* To determine the efficacy of Antineoplaston therapy in patients with Stage IV bladder cancer, 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 Stage IV bladder cancer. * 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.
Status Flow
Change History
8 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE2
-
Sep 2024 — Present [monthly]
Terminated PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE2
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE2
▶ Show 3 earlier versions
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Oct 2017 — Jun 2018 [monthly]
Terminated PHASE2
Status: Unknown Status → Terminated
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Feb 2017 — Oct 2017 [monthly]
Unknown Status PHASE2
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Jan 2017 — Feb 2017 [monthly]
Unknown Status PHASE2
First recorded
May 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 .