Melanoma (Skin) Clinical Trial
Official title:
Temozolomide Combined With Bevacizumab in Metastatic Melanoma. A Multicenter Phase II Trial
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. Bevacizumab may also stop the growth of
tumor cells by blocking blood flow to the tumor. Giving temozolomide together with
bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with
bevacizumab works in treating patients with stage IV melanoma that cannot be removed by
surgery.
OBJECTIVES:
Primary
- To evaluate the efficacy of temozolomide in combination with bevacizumab in patients
with unresectable stage IV melanoma.
Secondary
- To evaluate the safety and tolerability of this regimen.
Tertiary
- To evaluate the prognostic and predictive significance of circulating endothelial cells
and endothelial progenitor cells in patients treated with this regimen.
- To predict tumor response and outcome in patients treated with this regimen by
measuring hypermethylation of the tumor.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-7 and bevacizumab IV over 30-90
minutes on day 1. Courses repeat every 14 days in the absence of disease progression or
unacceptable toxicity.
Blood is collected at baseline and on day 1 of course 2. Samples are analyzed for
circulating endothelial cells and endothelial progenitor cells by flow cytometry and pro-
and anti-angiogenic serum factors by ELISA. Paraffin-embedded tumor tissue is analyzed for
MGMT promoter methylation status by methylation-specific PCR; MGMT protein expression by
IHC; and MSH2, MSH6, and MLH-1 expression (DNA repair enzymes).
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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