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| ID | Type | Description | Link |
|---|---|---|---|
| RECF0287 | Registry Identifier | INCA |
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In view of the slowness of the inclusions and the difficulty of carrying out the study, it was decided to put an end to this study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fotemustine | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fotemustine | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between MGMT expression and response to fotemustine | response with criteria OMS | from date of inclusion to death of patient |
| Relationship between MGMT expression and response to fotemustine | response with criteria OMS | from date of inclusion to progression documentation |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic malignant melanoma, meeting the following criteria:
Measurable or evaluable disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Didier Cupissol, MD, PhD | Institut du Cancer de Montpellier - Val d'Aurelle | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8347541 | Background | Baughan CA, Hall VL, Leppard BJ, Perkins PJ. Follow-up in stage I cutaneous malignant melanoma: an audit. Clin Oncol (R Coll Radiol). 1993;5(3):174-80. doi: 10.1016/s0936-6555(05)80321-8. | |
| 8221576 | Background | Sirott MN, Bajorin DF, Wong GY, Tao Y, Chapman PB, Templeton MA, Houghton AN. Prognostic factors in patients with metastatic malignant melanoma. A multivariate analysis. Cancer. 1993 Nov 15;72(10):3091-8. doi: 10.1002/1097-0142(19931115)72:103.0.co;2-v. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C054368 | fotemustine |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |