A Phase I Trial of Enzastaurin (LY317615) in Combination With Carboplatin in Adults With Recurrent Gliomas
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety and effectiveness of Enzastaurin, an experimental drug
that may prevent the growth of tumor vessels, in combination with Carboplatin, for patients
who have a glioma, a type of brain tumor. Carboplatin is used for treating many kinds of
cancers, though not recurrent gliomas. Tumor growth involves new cancer cell formation and
accumulation, requiring a blood supply. Research shows that brain tumor cells can produce
substances that stimulate new blood vessel formation. This study will look into whether the
combination of drugs can stop that process.
Patients ages 18 and older who have recurring gliomas, who are not pregnant or breast
feeding, and who do not have serious diseases may be eligible for this study. About 96
patients will participate for 1 year. They will have a physical examination, give blood and
urine samples for analysis, and undergo magnetic resonance imaging (MRI) or computed
tomography (CT) scans regarding tumor growth, and perhaps an electrocardiogram. Patients may
also undergo a dynamic MRI with spectroscopy or PET scan (positron emission tomography), to
distinguish a live tumor from a dying one. Researchers are studying patients taking a certain
type of antiseizure medicine and patients who are not taking it because some antiseizure
medicines may change the way the body handles a drug such as Enzastaurin. There will be two
groups of participants, with 16 to 48 each. Group A is not taking enzyme-inducing antiseizure
drugs, and Group B is taking such drugs. In Groups A and B are four dose levels, with 4 to12
patients at each level. Patients' doctors will tell them which group they belong to and how
much Enzastaurin and Carboplatin they will take. Treatment consists of Enzastaurin every day
for 5 weeks in Cycle 1 only and for 4 weeks beginning with Cycle 2 (each 4-week period as a
cycle). Patients take Enzastaurin within 30 minutes after a meal. History, physical, and
neurological examinations are repeated at the end of Cycle 1 and then every 4 weeks. Patients
will have a repeat head MRI or CT scan before each cycle. If they tolerate the drugs without
serious side effects and the tumor is not growing, they may continue with another cycle of
Enzastaurin, taking the tablets every day, and Carboplatin being infused on Day 8 of Cycle 1
and on Day 1 of each additional cycle. Routine lab tests are done regularly. Patients will
continue the 4-week cycles of treatment for as long as they have no serious side effects and
there are no signs of tumor growth. Side effects of Enzastaurin may be fatigue, constipation,
cough, and nausea. In men, there may be a decrease in sperm count. Carboplatin can lead to
low counts in blood cells and platelets, and there may also be an allergic reaction. Vomiting
is a likely side effect. At injection sites, there may be redness, swelling, and pain.
This study may or may not have a direct benefit for participants. However, information gained
may help the sponsor of the study, Eli Lilly and Company, and may help patients in the future
who have gliomas.