Melphalan/HDS for Ocular Melanoma

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Delcath Systems Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Patients in the study will be treated with Melphalan/HDS and will receive up to 6 total treatments. This study will evaluate the safety and effects of the treatment.

Research Team

Eligibility Criteria

Adults over 18 with ocular melanoma in the liver, weighing at least 35 kg, and not treated for cancer within the last month. They must have good liver function and overall health (ECOG PS of 0-1), no severe heart or lung conditions, no allergies to melphalan or latex, and not be pregnant. Participants should agree to use effective contraception.

Inclusion Criteria

Provided signed informed consent

You must weigh at least 35 kilograms because of the way the treatment is given through a catheter in the leg.

Half or less of my liver is affected by eye melanoma.

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Exclusion Criteria

I have severe liver disease with symptoms like portal hypertension.

I am a woman who can have children and cannot stop my periods during treatment.

I agree to use effective birth control during and 6 months after the study.

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Treatment Details

Interventions

Melphalan (Alkylating agents)

Trial OverviewThe trial is testing a treatment called Melphalan/HDS for patients with ocular melanoma that has spread mainly to the liver. Patients will receive up to six treatments of Melphalan administered through a Hepatic Delivery System designed to target the liver directly.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Melphalan/HDSExperimental Treatment1 Intervention

Eligible patients will be treated with Melphalan/HDS 3.0 mg/kg Ideal Body Weight (IBW). Melphalan/HDS treatment will be administered every 6 weeks for a total of 6 cycles with an acceptable delay of another 2 weeks before the next planned treatment to allow for recovery of melphalan-related toxicity, if needed.