Small Cell Lung Cancer Extensive Stage Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Small Cell Carcinoma of the Lung
Current therapies for Recurrent or Extensive-Stage Small Cell Lung 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 Recurrent or Extensive-Stage Small Cell Lung
Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Recurrent or Extensive-Stage Small Cell Lung
Cancer.
OVERVIEW: This is a single arm, open-label study in which patients with Recurrent or
Extensive-Stage Small Cell Lung 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 Recurrent or
Extensive-Stage Small Cell Lung 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
Recurrent or Extensive-Stage Small Cell Lung 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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