Melanoma (Skin)
Conditions
Keywords
recurrent melanoma, stage IV melanoma
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.
Interventions
DRUGfotemustine
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship between MGMT expression and response to fotemustine | from date of inclusion to death of patient | response with criteria OMS |
Countries
France
Outcome results
None listed