NCT01857752

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
DRUG	Temozolomide

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-05-20
• Last updated: 2017-01-30

Locations

1 site across 1 country: Guatemala