Stage IV Kidney Cancer Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Kidney
Current therapies for Stage IV Kidney Cancer provide very limited benefit to the patient. The
anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the
treatment of Stage IV Kidney Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Stage IV Kidney Cancer.
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV Kidney
Cancer receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal +
Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in
the absence of disease progression or unacceptable toxicity.
OBJECTIVE S:
- To determine the efficacy of Antineoplaston therapy in patients with Stage IV Kidney
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 Kidney 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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05025748 -
Ask Questions (ASQ):Implementation of a Communication Intervention
|
N/A |