A Phase II Study Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma
PRIMARY OBJECTIVES:
I. Determine the antitumor response rate (complete and partial response) in patients with
recurrent inoperable stage III or IV melanoma treated with VEGF Trap.
II. Compare the progression-free survival of patients treated with this regimen vs
historical controls.
SECONDARY OBJECTIVES:
I. Determine the overall survival of patients treated with this regimen. II. Determine the
toxicity and tolerability of this regimen in these patients. III. Determine the impact of
this regimen on laboratory correlates including anti-VEGF Trap antibody testing and
pharmacokinetics in these patients.
OUTLINE: This is a multicenter study.
Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days for at
least 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, prior to course 2, and 60 days after completion of
study treatment for pharmacokinetic and pharmacodynamic studies. Samples are analyzed by
enzyme-linked immunosorbent assay.
After completion of study treatment, patients are followed periodically for 5 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (CR + PR)
Up to 5 years
No
Ahmad Tarhini
Principal Investigator
City of Hope Medical Center
United States: Food and Drug Administration
NCI-2009-00182
NCT00450255
June 2007
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |