Stage IV Adrenocortical Carcinoma Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Adrenal Gland
Current therapies for Stage IV adrenal gland 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 adrenal gland cancer
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV adrenal
gland 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.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Stage IV adrenal
gland 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 adrenal gland 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 | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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