Phase II Trial of Extended-Dosing Temozolomide in Patients With Melanoma
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Temozolomide (also known as TMZ) is a chemotherapy drug given by mouth. It is similar to
DTIC, the only FDA-approved chemotherapy for melanoma, but because temozolomide is given by
mouth, it can be given daily over a long period of time. We think that temozolomidemay work
best if it is given every day for 6 weeks at a time. Temozolomide given by this extended
schedule is experimental, although we have found that it is safe and can shrink melanoma in
some patients.
One big advantage of TMZ is that it is given by mouth instead of by vein. This means that it
can be given daily over a long period of time rather than off and on like DTIC. We think that
TMZ may work better if it is given every day for 6 weeks. TMZ given by this extended schedule
is experimental although we have found that TMZ given in this way is safe and can shrink
melanoma in some patients. When extended dosing TMZ was given with either thalidomide or
long-acting interferon-α, about 30% of patients had their tumors shrink. We think that this
shrinkage was due mostly to the TMZ since neither thalidomide nor interferon-α alpha work in
melanoma by themselves.
In this study, we will treat patients with TMZ alone using this extended dosing schedule to
see how many patients experience tumor shrinkage.
We also want to learn more about which tumors are more likely to shrink from TMZ treatment.
We will test samples of your tumor for whether or not a gene called MGMT has been turned on,