Trial Information

Summary: A phase II study of combination therapy of a protracted oral schedule of temozolomide and thalidomide as first-line or subsequent therapy for patients with metastatic, locally advanced or unresectable leiomyosarcoma.

Study Description:

This study will assess the effectiveness of an experimental drug combination of temozolomide and thalidomide in reducing the recurrence of cancer for patients with advanced leiomyosarcoma. In addition the study will be attempting to assess effects of this treatment on blood vessel formation in these tumors, and determine the best dose and any side effects of the therapy. Temozolomide will be taken orally for seven consecutive days, every other week. Thalidomide will be taken orally every day for the duration of study participation. Physical examinations, blood tests and CT scans will obtained at baseline and approximately every 8 weeks.

Patient Inclusion/Exclusion Criteria:

• Patients will be adults with histologically confirmed leiomyosarcoma.
• Prior systemic chemotherapy will be allowed as well as radiation therapy or surgery.
• All patients must comply with the requirements of the System for Thalidomide Education and Prescribing Safety (Enhanced S.T.E.P.S.™).

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