Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction
Status:
Completed
Trial end date:
2017-10-25
Target enrollment:
Participant gender:
Summary
Background:
- Belinostat is an experimental cancer treatment drug that works by helping to turn on genes
that limit cell growth and survival of cancer cells. These genes are often switched off in
tumors. Belinostat has been given to patients with different types of cancer to measure its
safety and effectiveness, but it has not been given in a formal trial to cancer patients who
have abnormal liver function. Because belinostat is processed by the liver, its safety and
effectiveness needs to be established in individuals who have abnormal liver function.
Researchers are interested in comparing the effects of belinostat as a cancer treatment drug
in individuals with normal and abnormal liver function.
Objectives:
- To test the safety and effectiveness of belinostat in individuals who have solid tumors
and lymphomas and who also have abnormal liver function.
- To compare the results of belinostat treatment in individuals with normal and abnormal
liver function.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with solid tumors or
lymphomas that have not responded to standard treatment.
- Individuals with normal liver function and varying degrees of abnormal liver function
(mild, moderate, severe) are eligible.
Design:
- Participants will be screened with a full medical history and physical examination, as
well as blood and urine tests, and tumor imaging studies. Participants will then be
divided into study groups based on their liver function.
- Participants will receive belinostat in cycles of treatment. Except for cycle 1, all
cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will
receive a single dose of belinostat 1 week before the regular 21-day treatment cycle
starts.
- In each cycle, participants will receive belinostat once a day for 5 days, and will be
asked to keep a medication diary to record any side effects.
- Participants will have regular clinic visits with blood and urine sample collection and
imaging studies to evaluate the cancer's response to treatment.
- Participants may continue to take belinostat for as long as the cancer responds to the
treatment.