Imatinib in Adult Patients With Metastatic Ocular Melanoma

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborators: National Cancer Institute, France; Novartis
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Metastatic ocular melanoma

• Age > or = 18 years old

• Measurable metastases > or = 10 mm according to RECIST criteria

• PS-WHO < or = 1 or IK > 70 percent

• Normal hepatic function

• PNN > 1500/mm3, platelets > or = 100 000/mm3

• Contraception

• Informed consent signed

Exclusion Criteria:

• Patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association)

• Other evolutive neoplasic disease

• Severe hepatic insufficiency

• Severe renal insufficiency

• Somatic or psychiatric co-morbidity incompatible with the protocol

• Leptomeningeal or cerebral metastatic dissemination

• Pregnant or lactating woman

• Other antitumoral treatment

• Patient participating to another clinical trial with an experimental drug

• Known hypersensitivity to Imatinib or one of its excipients

• Resecable single metastasis