Fotemustine in Treating Patients With Metastatic Melanoma

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560118
• Other study ID #: CDR0000574147
• Secondary ID: CLCC-MGFOT-1INCA
• Status: Completed
• Phase: Phase 2
• First received: November 16, 2007
• Last updated: May 13, 2011
• Start date: August 2003

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic malignant melanoma, meeting the following criteria:

• Metastatic lymph nodes or skin allowing for surgical resection

• At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)

• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• ANC > 2 x 10^9/L

• Platelet count > 100 x 10^9/L

• Transaminases = 2.5 times normal

• Alkaline phosphate = 2.5 times normal

• Total bilirubin normal

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No severe uncontrolled infection

• No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated)

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy

• At least 2 weeks since prior adjuvant therapy

• At least 4 weeks since prior radiotherapy

• At least 30 days since prior participation in another clinical trial

• No prior or concurrent prophylactic phenytoin

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• fotemustine

Genetic:
• gene expression analysis

• polymerase chain reaction

Locations

Country	Name	City	State
France	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between MGMT expression and response to fotemustine			No
Secondary	Value for MGMT expression below which fotemustine has a strong probability of effectiveness			No