Approval Probability
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regional chemotherapy · 1 trial · 3 indications
| 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...
Regional chemotherapy is used to treat unresectable liver metastases due to melanoma, including intraocular melanoma. It is delivered via hepatic arterial infusion with melphalan, a form of liver-directed therapy for patients with melanoma that has spread to the liver.
Regional chemotherapy targets melanoma cells that have metastasized to the liver. The treatment involves infusing melphalan directly into the hepatic artery, delivering a high concentration of the chemotherapy drug to liver tumors while limiting systemic exposure.
Regional chemotherapy is developed by Delcath Systems, Inc., a company traded on the stock exchange under the ticker DCTH. The company focuses on liver-directed cancer therapies.
Regional chemotherapy has completed a Phase 3 clinical trial. The trial, NCT00324727, was a randomized, active-controlled study that has been completed. The drug is not approved and remains investigational for this indication.
Regional chemotherapy was studied in one Phase 3 clinical trial, NCT00324727, titled 'Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma.' The trial enrolled 93 patients in the United States and has been completed.
Yes, regional chemotherapy refers to the treatment approach of hepatic arterial infusion with melphalan, as studied in the clinical trial NCT00324727. This approach delivers chemotherapy directly to the liver to treat unresectable liver metastases from melanoma.