Stage IV Melanoma Clinical Trial
Official title:
A Phase 2 Study Evaluating the Efficacy of VEGF Trap in Patients With Recurrent Inoperable Stage III or Stage IV Melanoma
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery. Combinations of biological substances in VEGF Trap may be able to carry tumor-killing substances directly to melanoma cells. It may also stop the growth of melanoma by blocking blood flow to the tumor.
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.
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