Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00324727 | Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma | PHASE3 | COMPLETED | 93 | — | — | Feb 1, 2006 | Aug 1, 2012 | Jun 21, 2021 | 12 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm I | EXPERIMENTAL | Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity. |
| Arm II | ACTIVE_COMPARATOR | Patients receive the best alternative therapy comprising supportive care, systemic or regional chemotherapy, hepatic artery (chemo)-embolization, or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician. Patients may cross over to arm I if they have evidence of disease progression. |
| Name | Type | Description |
|---|---|---|
| melphalan | DRUG | Given throug isolated hepatic artery infusion |
| regional chemotherapy | DRUG | Patients receive the best alternative therapy |
| systemic chemotherapy | DRUG | Patients receive the best alternative therapy |
| hepatic artery embolization | PROCEDURE | Patients receive the best alternative therapy |
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed liver metastases secondary to cutaneous or ocular melanoma * Unresectable disease * Predominantly in the parenchyma of the liver * Measurable disease by CT scan and/or MRI * Limited unresectable extrahepatic disease allowed p...