Fotemustine in Treating Patients With Metastatic Melanoma (MGFOT1)

February 11, 2025 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: fotemustine
Other Names:
  • experimental arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between MGMT expression and response to fotemustine
Time Frame: from date of inclusion to death of patient
response with criteria OMS
from date of inclusion to death of patient
Relationship between MGMT expression and response to fotemustine
Time Frame: from date of inclusion to progression documentation
response with criteria OMS
from date of inclusion to progression documentation

Secondary Outcome Measures

Outcome Measure
Value for MGMT expression below which fotemustine has a strong probability of effectiveness

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Didier Cupissol, MD, PhD, Institut du Cancer de Montpellier - Val d'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2003

Primary Completion (Actual)

August 31, 2008

Study Completion (Actual)

August 31, 2008

Study Registration Dates

First Submitted

November 16, 2007

First Submitted That Met QC Criteria

November 16, 2007

First Posted (Estimated)

November 19, 2007

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000574147
  • RECF0287 (Registry Identifier: INCA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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