MLN4924 Compared With MLN4924 Plus Chemotherapy for Large B-cell Lymphoma
Status:
Withdrawn
Trial end date:
2014-01-07
Target enrollment:
Participant gender:
Summary
Background:
- MLN4924 is an experimental cancer drug. It may help kill lymphoma cells and make them more
sensitive to chemotherapy. EPOCH R is a combination chemotherapy drug. It has been effective
in treating some cases of large B-cell lymphoma. This research will look at two things. The
first is the effect of MLN4924 on its own in treating large B-cell lymphoma. The second is
the safe dose and effect of MLN4924 and EPOCH-R in combination when treating large B-cell
lymphoma.
Objectives:
- To study how MLN4924 affects large B-cell lymphoma tumors.
- To compare the effects of MLN 4924 alone and MLN4924 plus standard EPOCH-R chemotherapy.
Eligibility:
- Individuals at least 18 years of age who have large B-cell lymphoma that will be treated
with chemotherapy.
Design:
- Participants will be screened with a medical history and physical exam. They will also
have blood and urine tests, tumor samples, and imaging studies.
- Participants will receive MLN4924 for a maximum of six 21-day cycles of treatment. Each
cycle involves a dose of MLN4924 twice a week for 2 weeks, followed by a 1-week rest
period. Participants will be monitored with frequent blood tests and imaging studies.
- Participants who do not benefit from MLN4924 alone will have MLN4924 along with EPOCH-R
chemotherapy for up to six cycles of treatment.