Fotemustine in Treating Patients With Metastatic Melanoma
NCT ID: NCT00560118
Last Updated: 2025-02-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE2
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2003-08-08
Study Completion Date
2008-08-31
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.
PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.
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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.
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.
Conditions
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Melanoma (Skin)
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Fotemustine
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
Group Type
EXPERIMENTAL
fotemustine
Intervention Type
DRUG
Interventions
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fotemustine
Intervention Type
DRUG
Other Intervention Names
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experimental arm
Eligibility Criteria
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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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
120 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Didier Cupissol, MD, PhD
Role: STUDY_CHAIR
Institut du Cancer de Montpellier - Val d'Aurelle
Locations
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Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
Site Status
Countries
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France
References
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Other Identifiers
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RECF0287
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000574147
Identifier Type: -
Identifier Source: org_study_id
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