Ignite Creation Date:
2024-05-05 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00560118
Status:
COMPLETED
Last Update Posted:
2011-05-16
First Post:
2007-11-16
Brief Title:
Fotemustine in Treating Patients With Metastatic Melanoma
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| INCA-RECF0287 | None | None | None |
| CLCC-MGFOT-1 | None | None | None |