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
- Assess the relationship between MGMT expression and response to fotemustine in patients
with metastatic malignant melanoma.
- Establish a value for MGMT expression below which fotemustine has a strong probability
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
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
Relationship between MGMT expression and response to fotemustine
Didier Cupissol, MD, PhD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government