Fotemustine in Treating Patients With Metastatic Melanoma

Phase 2

Terminated

• Conditions: Melanoma (Skin)
• Interventions: Drug: fotemustine

• Registration Number: NCT00560118
• Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle

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.

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.

Study Timeline

• Study Start: 2003-08-08
• Study First Submitted: 2007-11-16
• Study First Submitted QC: 2007-11-16
• Study First Posted: 2007-11-19
• Primary Completion: 2008-08-31
• Study Completion: 2008-08-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fotemustine	fotemustine	Induction treatment Fotémustine 100mg / m² IV sur 1 h J1, J8, J15 Traitement d'entretien : Fotémustine 100 mg / m² IV sur 1 h - J1 = J21

Primary Outcome Measures

Name	Time	Method
Relationship between MGMT expression and response to fotemustine	from date of inclusion to progression documentation	response with criteria OMS

Trial Locations

Locations (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle; 🇫🇷 Montpellier, France