Fotemustine in Treating Patients With Metastatic Melanoma - Full Text View

Sponsored by:	Centre Val d'Aurelle - Paul Lamarque
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00560118

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 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Fotemustine

U.S. FDA Resources

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

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

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

Keywords provided by National Cancer Institute (NCI):

recurrent melanoma
stage IV melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Fotemustine

Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on September 11, 2009