Fotemustine in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Drug: fotemustine
* Genetic: gene expression analysis
* Genetic: polymerase chain reaction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fotemustine|nan|
|Genetic: gene expression analysis|nan|
|Genetic: polymerase chain reaction|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between MGMT expression and response to fotemustine |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Value for MGMT expression below which fotemustine has a strong probability of effectiveness |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent melanoma, stage IV melanoma