At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed, surgically nonresectable Stage III or IV metastatic cutaneous, mucosal, or choroidal melanoma
- ✓Secondary tumor involvement of the liver confirmed by CT scan with bilirubin 1.6–3.0 mg/dL (Grade 2)
- ✓Bidimensionally measurable disease
- ✓Nonchoroidal melanoma patients must have received prior chemotherapy for metastatic disease with cytotoxic or biological drugs
- ✕Radiotherapy, chemotherapy, immunotherapy, vaccine, or alternative anticancer treatment within 3 weeks prior to enrollment
- ✕Hepatic chemo-embolization within 4 weeks prior to enrollment
- ✕Severe hepatic impairment: plasma ammonia >105 mMol/L, or serum albumin <2.0 g/dL, or bilirubin >3.0 mg/dL
- ✕Advanced symptomatic CNS involvement by melanoma, or those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal carcinomatosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases
In Brief
A Phase 1 clinical trial evaluating Vincristine Sulfate Liposomes Injection for Malignant Melanoma. Completed, enrolled 7 participants across 1 site.
Detailed Summary
The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in liver impairment, and who have relapsed after previous therapies.
Study Details
Timeline
Interventions
Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.