Research & Clinical Trials
Dr. Arenson Directs Study of Promising New Drug
Dr. Arenson and the CNI Center for Brain and Spinal Tumors are
currently participating in a national study to test the safety and
efficacy of a new drug called Xerecept. Xerecept, which is the name
given to human corticotropin releasing factor, is a potent agent
in reducing brain swelling.
The purpose of the study is to provide a means of reducing the
dependency of patients with central nervous system tumors on the
drug dexamethasone. Dexamethasone is currently the standard treatment
that is given to patients whose brain is swollen from such tumors
and cannot function without the addition of dexamethasone. While
very effective, this drug carries numerous severe short and long-term
side effects, including immunosuppression, muscle and bone destruction,
diabetes mellitus, cataracts, weight gain and fluid retention as
well as psychological and emotional effects such as insomnia.
Therefore, any drug which could accomplish the goal of reducing
brain swelling with fewer side effects would be highly desirable.
Xerecept must be given by injection, which is one limitation. However,
in patients that are dependent on at least 4 mg/day of dexamethasone,
the injections are well worth it if the patient’s Decadron
dependency can be reduced or eliminated.
This is a double-blind placebo-controlled study in which patients
may have approximately a 50% chance at the beginning of receiving
the drug versus a placebo. However, after two weeks, if it cannot
be established that the drug the patient is receiving has been effective
in allowing at least a 50% reduction in the dose of dexamethasone,
the patient can discontinue the medication and would be eligible
to receive the actual medication approximately three months later
on a second study.
This is a unique study design which is unusual in new drug development
and is very desirable to patients who find themselves dependent
upon dexamethasone.
Patients interested in being on this study must be available during
a course of 12 weeks to be examined quite frequently by Dr. Arenson
or one of his associates. Therefore, it is most applicable to patients
who live within a reasonable distance of Denver. However, for those
who are able and willing to come to Denver on a frequent enough
basis, there is no prohibition to their being eligible for this
study.
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