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Fotemustine in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00560118
First Posted: November 19, 2007
Last Update Posted: May 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin) Drug: fotemustine Genetic: gene expression analysis Genetic: polymerase chain reaction Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment: 60
Study Start Date: August 2003
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00560118


Locations
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Study Chair: Didier Cupissol, MD, PhD Institut du Cancer de Montpellier - Val d'Aurelle
  More Information

ClinicalTrials.gov Identifier: NCT00560118     History of Changes
Other Study ID Numbers: CDR0000574147
CLCC-MGFOT-1
INCA-RECF0287
First Submitted: November 16, 2007
First Posted: November 19, 2007
Last Update Posted: May 16, 2011
Last Verified: December 2008

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Fotemustine
Antineoplastic Agents