Melanoma Clinical Trial
Official title:
A Phase II Study of Temozolomide, Thalidomide, and Lomustine (TTL) in Patients With Metastatic Melanoma in the Brain
The primary objective of the phase II study is to assess the objective (CR+PR) response rate at a maximum tolerated dose (MTD) of Lomustine in combination with Temozolomide and Thalidomide after the first cycle (8 weeks) in patients with metastatic melanoma in the brain. Secondary objectives include the evaluation of objective response in the extracranial metastases, duration of response and overall survival.
The dosages of Temozolomide and Thalidomide will be fixed, and the dose of Lomustine will be
the phase I MTD or the highest dose studied if the MTD was not attained.
All 3 drugs will be taken by mouth at home. Each treatment cycle will last for 8 weeks.
Temozolomide will be taken once a day for 6 weeks followed by two weeks off. You will take
thalidomide every day for the entire 8-week cycle. Thalidomide should also be taken near
bedtime, usually 30 to 45 minutes before the temozolomide dose. You will take 2 doses of
lomustine every 8 weeks. You will take the first dose of lomustine on Day 1 of the 8-week
cycle. You will take the second dose, which will be half as big as the first dose, on Day 29
(the day after the first 4 weeks) of the 8-week cycle. The dose of lomustine is also based
on your height and weight. Lomustine should be swallowed and not chewed.
A maximum of 30 patients will be enrolled,
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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