Fotemustine in Treating Patients With Metastatic Melanoma

NCT00560118 | Terminated Phase 2

• 2 other identifiers: CDR0000574147RECF0287
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Drug: fotemustine

Interventions

fotemustine DRUG

Also known as: experimental arm

Fotemustine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

Related Publications (32)

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MeSH Terms

Conditions

Melanoma

Interventions

fotemustine

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Didier Cupissol, MD, PhD

  Institut du Cancer de Montpellier - Val d'Aurelle

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2007
• First Posted: November 19, 2007
• Study Start: August 8, 2003
• Primary Completion: August 31, 2008
• Study Completion: August 31, 2008
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)