Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala

Summary

Primary Objectives: 1. To investigate the response rate (complete response plus partial response) of temozolomide for 8 weeks (2 cycles), in patients with retinoblastoma metastatic to the central nervous system (mass only) in two strata: * A. Initial diagnosis (mass) * B. At relapse (mass) 2. To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and hemoglobin count. Secondary Objectives: 1. To determine the response in other metastatic sites (non target) (orbit, bone marrow, bone, lung, liver and others) 2. To determine the remission rate and time to relapse on temozolomide. 3. To document the response of leptomeningeal metastasis (cerebrospinal fluid) to temozolomide

Timeline

Start

2012-03

Primary completion

2015-06

Completion

2015-06

Outcome

Outcome not reported

Stopped (Enrollment): “accrual”

Drugs

Indications