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Fotemustine in Treating Patients With Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
fotemustine
gene expression analysis
polymerase chain reaction
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Outcomes

Primary Outcome Measures

Relationship between MGMT expression and response to fotemustine

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2007
Last Updated
May 13, 2011
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT00560118
Brief Title
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

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fotemustine
Intervention Type
Genetic
Intervention Name(s)
gene expression analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Primary Outcome Measure Information:
Title
Relationship between MGMT expression and response to fotemustine
Secondary Outcome Measure Information:
Title
Value for MGMT expression below which fotemustine has a strong probability of effectiveness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Cupissol, MD, PhD
Organizational Affiliation
Institut du Cancer de Montpellier - Val d'Aurelle
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

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Fotemustine in Treating Patients With Metastatic Melanoma

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