Trial Information

Summary: A phase II study of a 4-hour schedule of Temozolomide in the treatment of patients with advanced melanoma.

Study Description

The primary objective of this study is to evaluate the effectiveness of a 4-hourly schedule of temozolomide as measured by overall objective response rate. In addition, the study also aims to assess the 1) side effects of this dose/schedule, 2) response of the disease to this treatment, 3) time to progression, and 4) overall survival.

Temozolomide will be taken orally in 5 doses over a 16-hour period every 28 days for 2 cycles. Physical examinations, blood tests and CT scans will be obtained at baseline and approximately every 4 weeks until the end of the study.

Patient Inclusion/Exclusion Criteria:

• Up to 25 adult patients with histologically confirmed advanced malignant melanoma will participate in this study.
• Two prior systemic chemotherapy regimens will be allowed as well as radiation therapy or surgery.
• Patients should have no acute infection requiring systemic antibiotics.
• Patients who experience frequent vomiting or any medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction) will not be eligible.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.