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About
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial studies the effectiveness of antineoplaston therapy in treating women who have stage IV breast cancer that has not responded to previous therapy.
Full description
OVERVIEW: This is a single arm, open-label study in which patients with Stage IV breast 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:
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
Measurable disease by MRI or CT scan
Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations
Hormone receptor status:
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Primary purpose
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Interventional model
Masking
19 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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