Low Dose Arsenic Trioxide as a Potential Chemotherapy Protector
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
Summary
Many types of cancer are treated with chemotherapy drugs and/or radiation therapy. These
forms of treatment, however, can also damage normal (non-cancer) cells and cause a variety of
side effects. There are many side effects of chemotherapy. A few examples are: lowered red
blood cell counts (anemia) which can lead to tiredness, weakness or shortness of breath;
lowered white cell counts (white blood cells which help the body to fight infection); low
platelet counts (platelets help blood to clot); nausea and vomiting; diarrhea; lip and mouth
sores and hair loss. These side effects can range from mild to severe. P53 is a protein in
the body that regulates the cell cycle. If a cell becomes damaged from chemotherapy or
radiation treatment, the p53 protein becomes activated. This activation can cause the cell to
die and is involved in causing side effects from chemotherapy or radiation therapy.
Arsenic trioxide is a drug that is currently approved by the FDA (Food and Drug
Administration) for the treatment of acute promyelocytic leukemia (APL), which is a type of
blood and bone marrow cancer. It is given by I.V (intravenous, by vein). New preclinical
studies have shown that when given in smaller than normal doses before treatment with
chemotherapy and/or radiation therapy, the arsenic trioxide can block the activation of p53
and protect normal tissues from treatment damage. Preclinical means that the studies have
been done in a laboratory and not on humans.
This study has two purposes. The first is to find the dose range for arsenic trioxide that
will block p53 activity. This dose has been determined from the first five subjects who took
part in the study and received arsenic trioxide. The dose of arsenic trioxide for this study
is about 1/30 of the normal dose given when arsenic trioxide is used to treat acute
promyelocytic leukemia. The second is to see if the arsenic trioxide will decrease the side
effects of chemotherapy. In this study, arsenic trioxide is investigational.
"Investigational" means that arsenic trioxide has not yet been approved by the FDA to block
p53 activity.
This study will help find out what the smallest (best) dose is that can be given and the
effects, good and/or bad, this drug has on people who take it. The safety of this drug in
humans has been tested in prior research studies; however, whether the side effects will
still be present at this lower dose is not yet known.
Phase:
Phase 2
Details
Lead Sponsor:
The University of Texas Health Science Center at San Antonio