Clinical trial · Interventional
Fotemustine in Treating Patients With Metastatic Melanoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fotemustine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fotemustine
- description
- 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
- interventionNames
- Drug: fotemustine
Primary outcomes (2)
- measure
- Relationship between MGMT expression and response to fotemustine
- timeFrame
- from date of inclusion to death of patient
- description
- response with criteria OMS
- measure
- Relationship between MGMT expression and response to fotemustine
- timeFrame
- from date of inclusion to progression documentation
- description
- response with criteria OMS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (32)
- BACKGROUNDBaughan 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. PMID 8347541
- BACKGROUNDSirott 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. PMID 8221576
- BACKGROUNDBattayani Z, Grob JJ, Xerri L, Noe C, Zarour H, Houvaeneghel G, Delpero JR, Birmbaum D, Hassoun J, Bonerandi JJ. Polymerase chain reaction detection of circulating melanocytes as a prognostic marker in patients with melanoma. Arch Dermatol. 1995 Apr;131(4):443-7. PMID 7726587
- BACKGROUNDHauschild A, Michaelsen J, Brenner W, Rudolph P, Glaser R, Henze E, Christophers E. Prognostic significance of serum S100B detection compared with routine blood parameters in advanced metastatic melanoma patients. Melanoma Res. 1999 Apr;9(2):155-61. doi: 10.1097/00008390-199904000-00008. PMID 10380938
- BACKGROUNDKageshita T, Yoshii A, Kimura T, Kuriya N, Ono T, Tsujisaki M, Imai K, Ferrone S. Clinical relevance of ICAM-1 expression in primary lesions and serum of patients with malignant melanoma. Cancer Res. 1993 Oct 15;53(20):4927-32. PMID 8104688
- BACKGROUNDLuca M, Hunt B, Bucana CD, Johnson JP, Fidler IJ, Bar-Eli M. Direct correlation between MUC18 expression and metastatic potential of human melanoma cells. Melanoma Res. 1993 Feb;3(1):35-41. doi: 10.1097/00008390-199304000-00006. PMID 8471835
- BACKGROUNDHieken TJ, Ronan SG, Farolan M, Shilkaitis AL, Das Gupta TK. Molecular prognostic markers in intermediate-thickness cutaneous malignant melanoma. Cancer. 1999 Jan 15;85(2):375-82. doi: 10.1002/(sici)1097-0142(19990115)85:23.0.co;2-1.