A Phase II, Pharmacologic and Biologic Study of Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day in Combination With a Fixed Dose of SU5416 (NSC #696819) in Patients With Metastatic Melanoma
I. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.
II. Determine the quantitative and qualitative toxic effects of this regimen in these
III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the
complete and partial responses and response duration in patients treated with this regimen.
V. Assess disease-free survival at 6 months of patients treated with this regimen.
Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1
day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of
disease progression or unacceptable toxicity.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Eric K. Rowinsky, MD
University of Texas Health Science Center at San Antonio
United States: Food and Drug Administration
|University of Texas Health Science Center at San Antonio||San Antonio, Texas 78284-7811|