Conditions: Intraocular Melanoma
Keywords: ciliary body and choroid melanoma, medium/large size iris melanoma metastatic intraocular melanoma recurrent intraocular melanoma extraocular extension melanoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation.

Secondary

* To determine the median progression-free survival of patients treated with this regimen.
* To determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 8 weeks for 1 year.

Arms:
arm 1: Administered via intravenous bolus at a dose of 150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Interventions: intervention 1: nab-paclitaxel
Intervention descriptions: intervention 1: 150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Protocol document: