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Sponsored by: |
Centre Val d'Aurelle - Paul Lamarque |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00560118 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | August 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic malignant melanoma, meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
France | |
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | |
Montpellier, France, 34298 |
Study Chair: | Didier Cupissol, MD, PhD | Centre Val d'Aurelle - Paul Lamarque |
Study ID Numbers: | CDR0000574147, CLCC-MGFOT-1, INCA-RECF0287 |
Study First Received: | November 16, 2007 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00560118 History of Changes |
Health Authority: | United States: Federal Government |
recurrent melanoma stage IV melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Fotemustine |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Fotemustine Nevi and Melanomas Pharmacologic Actions Neuroendocrine Tumors Melanoma |