Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala
Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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