Conditions: Malignant Melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 7
Healthy volunteers: no

Brief 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.

Detailed description:
OBJECTIVES:

Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.

Secondary: To assess the safety and antitumor activity of VSLI in this population.

Arms:
arm 1: Single armed study; all subjects received VSLI

Interventions: intervention 1: Vincristine Sulfate Liposomes Injection
Intervention descriptions: intervention 1: Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.

Protocol document: