Fotemustine in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00560118
First received: November 16, 2007
Last updated: May 13, 2011
Last verified: December 2008
  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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Value for MGMT expression below which fotemustine has a strong probability of effectiveness [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560118

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00560118     History of Changes
Other Study ID Numbers: CDR0000574147, CLCC-MGFOT-1, INCA-RECF0287
Study First Received: November 16, 2007
Last Updated: May 13, 2011
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014