Melanoma (Skin) Clinical Trial
Official title:
Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop
the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Studying samples of tumor tissue from patients with cancer in the laboratory may help
doctors predict how well patients will respond to treatment.
PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating
patients with metastatic melanoma.
OBJECTIVES:
Primary
- Assess the relationship between MGMT expression and response to fotemustine in patients
with metastatic malignant melanoma.
Secondary
- Establish a value for MGMT expression below which fotemustine has a strong probability
of effectiveness.
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising fotemustine IV over 1 hour on days 1, 8,
and 15. Beginning 5 weeks later, patients achieving stable or objective response receive
maintenance chemotherapy comprising fotemustine IV over 1 hour once every 3 weeks for 6
courses.
Tissue samples are collected at baseline to assess level of MGMT expression by PCR.
After completion of study treatment, patients are followed every 2 months.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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