Temozolomide and Bevacizumab in Treating Patients With Metastatic Melanoma of the Eye

Conditions

• Intraocular Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
• temozolomide — DRUG
• polymorphism analysis — GENETIC
• pharmacogenomic studies — OTHER

Study Details

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving temozolomide together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying giving temozolomide together with bevacizumab to see how well they work in treating patients with metastatic melanoma of the eye.

Key Dates

First listed

Oct 8, 2010

Start date

Oct 31, 2009

Status verified

Aug 2012

Primary completion

Oct 31, 2012

Study Design

Enrollment

35 participants (estimated)

Primary purpose

TREATMENT

Primary Outcome Measure

Disease control rate, in terms of objective response rate and the stable disease rate determined according to RECIST criteria at 6 months