None listed
Conditions
Interventions
Irofulven Type of group
Irofulven will be administered in a dose of 0.55 mg / kg. The total dose should not exceed 50 mg. The administration will be done intravenously through a central venous catheter in a 30-minute infusion, on days 1 and 15, in cycles of 28 days.
Sponsors
MGI PHARMA, INC.,
Eligibility
Inclusion criteria
Inclusion criteria: - The patient must sign the written informed consent approved by the institutional committee for scientific review (IRB). - The patient must have a histological or cytological diagnosis of hepatocellular carcinoma that has been considered unresectable. - The patient should not have more than one previous therapeutic intervention for the treatment of hepatocellular carcinoma including surgical techniques, ablative, chemo-embolization, and systemic chemotherapy.
Exclusion criteria
Exclusion criteria: - Previous treatment with gene therapy. - Women who are pregnant or breast-feeding. - Patients with any concomitant systemic disorder (in the opinion of the researcher) - Patients who have completed or who have been withdrawn from this study or any other study with irofulven.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Presence of at least one measurable or non-measurable lesion. Measure:Objective tumor response Timepoints:every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:An adverse experience is any change in physical examination, symptoms and / or any change in the clinically significant laboratory. Measure:Safety of iroftilven administered every two weeks. Timepoints:Biweekly. | — |
Countries
Argentina, Belgium, France, Peru, Romania, United States
Outcome results
None listed