Fotemustine in Treating Patients With Metastatic Melanoma (MGFOT1)

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Terminated; Phase 2

Conditions: Melanoma (Skin)

Treatments: Drug: fotemustine

Study type: Interventional

Funder types: Other

Identifiers

NCT00560118

CDR0000574147

RECF0287 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Fotemustine

Experimental group

Description:

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

Treatment:

Drug: fotemustine