Acute Myelogenous Leukemia Clinical Trial
Official title:
Phase II Trial of Arsenic Trioxide With Ascorbic Acid in the Treatment of Adult Non-APL Acute Myelogenous Leukemia
This clinical research study is for patients with acute myelogenous leukemia (in short AML)
that did not respond to previous treatment or unable to receive chemotherapy.
Arsenic has been used as a drug for many centuries. While arsenic containing drugs were used
in the past for cancer treatments, the major use of arsenic in western countries has been
for the treatment of uncommon tropical illnesses, such as sleeping sickness. Recently, some
new information suggests that arsenic in a form called arsenic trioxide may also be useful
to treat some cancers of the blood, such as leukemia, lymphoma and myeloma. Studies from
China and the USA showed that patients with a type of blood cancer called acute
promyelocytic leukemia, whose disease failed to respond to other treatments, responded very
well to arsenic trioxide. Studies done in laboratories in the United States have shown that
arsenic can kill AML cells growing in culture dishes.
Ascorbic acid (vitamin C), a natural supplement in our diet, has long been involved with
cancer prevention. Laboratory tests have shown that although arsenic trioxide by itself can
kill AML cells in the test tube, when vitamin C is added to arsenic trioxide in a test tube,
the death of the leukemia cells increases significantly.
The purpose of this study is to find out if the combination of arsenic trioxide (Trisenox)
and ascorbic acid is effective in the treatment of patients who have AML. The second purpose
is to study how the two drugs affect cells in the laboratory. Samples from the blood and
bone marrow (the part of the body that makes blood cells) will be collected, at specific
times during treatment, in order to study them in the laboratory. By studying blood and
marrow cells, researchers hope to learn the mechanisms by which the drugs work.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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