Fotemustine in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00560118|
Recruitment Status : Completed
First Posted : November 19, 2007
Last Update Posted : May 16, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Drug: fotemustine Genetic: gene expression analysis Genetic: polymerase chain reaction||Phase 2|
- 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Study Start Date :||August 2003|
|Primary Completion Date :||May 2011|
- Relationship between MGMT expression and response to fotemustine
- Value for MGMT expression below which fotemustine has a strong probability of effectiveness
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560118
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Study Chair:||Didier Cupissol, MD, PhD||Institut du Cancer de Montpellier - Val d'Aurelle|