Leflunomide+Vemurafenib in V600 Mutant Met. Melanoma
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This research study was intended to be a Phase I/II clinical trial, but the trial was
terminated before the phase 1 portion was completed. Phase I clinical trials test the safety
of an investigational combination of drugs. Phase I studies also try to define the
appropriate dose of the investigational drug combination to use for the Phase II portion of
the study, which will enroll more participants and continue to study the effects of the drug
and the safest dose. "Investigational" means that the combination of vemurafenib and
leflunomide is still being studied and that research doctors are trying to find out more
about it. It also means that the FDA has not approved this drug combination for your type of
cancer.
Genes are a specific part of your cell materials which send code messages to determine what
the investigators bodies look like, such as eye color, and instruct cells to control growth
and development of the body. Researchers have found that a large number of melanoma cells
have mutations in the BRAF gene. Normally, the BRAF gene helps to control how cells grow.
Mutations in the BRAF gene may disrupt this control and allow cells in the skin to change
into cancer cells, in which case, the cells keep dividing and growing out of control.
Specifically, it has been shown that vemurafenib blocks the effects of these mutations in the
BRAF gene, and, as a result, may help to prevent cancer growth. The FDA has approved
vemurafenib for use in patients with BRAF mutation positive melanoma that is unable to be
removed by surgery (unresectable) or that has spread (metastatic).
Leflunomide is in a class of medications called disease-modifying antirheumatic drugs
(DMARDs). It is FDA approved for the treatment of rheumatoid arthritis and it is believed to
decrease inflammation in that setting. However it is not approved for treatment of melanoma.
The researchers of this study believe this agent may help prevent cancer growth as well as
enhance the properties of drugs that target the BRAF gene (such as vemurafenib) based on
recently published laboratory research, and would like to learn more about any effects this
combination may have on your disease.
The main purposes of this study are to determine the highest dose of vemurafenib and
leflunomide that can be given in combination without causing severe side effects, to see
whether the combination of vemurafenib and leflunomide is safe in participants with BRAF
mutant metastatic melanoma and to learn if the combination of vemurafenib and leflunomide
shows any signs of effectively treating your disease.