NO_LONGER_AVAILABLENot Applicable

Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver

United States

Plain-language summary

The safety and efficacy of CS-PHP-melphalan has been evaluated in a phase 3 trial conducted in the same patient population as well as using the same melphalan dosing as proposed in this study. This expanded access protocol will provide an experimental alternative treatment option for both physicians and patients until the Delcath CS-PHP System receives marketing approval.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically proven ocular/cutaneous melanoma with liver-dominant unresectable metastatic disease, defined as limited extra-hepatic disease and hepatic involvement which would, in the Investigator's opinion, result in morbidity and eventual mortality. Limited extra-hepatic disease considered acceptable includes:
✓. ≥1 measurable hepatic lesion per RECIST 1.1
✓. Vasculature compatible with insertion of CS-PHP catheters, per baseline abdominal MRA
✓. ECOG PS 0-2

Exclusion criteria

✕. Chemotherapy, radiotherapy, or biologic therapy for the malignancy ≤1 month prior to 1st CS-PHP-melphalan infusion
✕. Extensive prior radiotherapy, defined as treatment to ≥50% of marrow-containing bones
✕. Immunosuppressive drugs such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids taken currently or ≤3 mths prior to 1st CS-PHP-melphalan infusion
✕. Received an investigational product ≤30 days prior to the 1st CS-PHP-melphalan infusion
✕. History of orthotopic liver transplantation, untreated gastrinoma (i.e. gastric acid hypersecretion) or prior Whipple procedure
✕. Not recovered from side effects of prior therapy to ≤ Grade 1 NCI CTCAE 4.03
✕. Child's B or C cirrhosis, or clinical evidence of portal hypertension
✕. Patients with \>50% of liver replaced by tumor, histologic evidence of hepatic dysfunction seen by laparoscopic liver biopsy

Trial details

NCT IDNCT01728051

SponsorDelcath Systems Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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