Clinical trial NCT00560118: Fotemustine in Treating Patients With Metastatic Melanoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage IV melanoma
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2007-11-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Relationship between MGMT expression and response to fotemustine
timeFrame: from date of inclusion to death of patient
measure: Relationship between MGMT expression and response to fotemustine
timeFrame: from date of inclusion to progression documentation
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Didier Cupissol, MD, PhD
role: STUDY_CHAIR
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