Intraocular Melanoma Clinical Trial
Official title:
Phase II Single-Center Study of Bevacizumab in Combination With Temozolomide in Patients With First-Line Metastatic Uveal Melanoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some
block the ability of tumor cells to grow and spread. Others find tumor cells and help kill
them or carry tumor-killing substances to them. Giving temozolomide together with
bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to
see how well they work in treating patients with metastatic melanoma of the eye.
OBJECTIVES:
Primary
- To evaluate the efficacy of temozolomide in combination with bevacizumab in treating
patients with metastatic uveal melanoma not amenable to curative surgery.
Secondary
- To determine response rate in these patients.
- To determine duration of response in these patients.
- To determine progression-free survival of these patients.
- To determine overall survival of these patients.
- To determine the safety of treatment with this regimen in these patients.
- To study the CT perfusion imaging for functional imaging of response in these patients.
- To determine the pharmacogenetic influence of constitutional VEGF-A polymorphism on the
efficacy and toxicity of bevacizumab. (ancillary)
OUTLINE: Patients receive oral temozolomide once daily on days 1-7 and 15-21 and bevacizumab
IV over 30-90 minutes on days 8 and 22. Treatment repeats every 28 days for up to 6 courses.
Patients achieving at least stable disease then receive bevacizumab monotherapy IV every 2
weeks as maintenance therapy in the absence of unacceptable toxicity and disease
progression. Patients undergo CT perfusion imaging at baseline, day 28, and at 3 and 6
months.
Blood samples are collected at baseline and then periodically for VEGF-A genetic
polymorphism analysis.
After completion of study treatment, patients are followed up at 1 month.
;
Masking: Open Label, Primary Purpose: Treatment
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