Clinical Trial: Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Study Temozolomide for Retinoblastoma Metastatic to the Central Nervous System for Patients From Guatemala
Brief Summary:
Primary Objectives:
-
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)
- To determine hematologic toxicity: absolute neutrophil count (ANC), platelets and hemoglobin count.
Secondary Objectives:
- To determine the response in other metastatic sites (non target) (orbit, bone marrow, bone, lung, liver and others)
- To determine the remission rate and time to relapse on temozolomide.
- To document the response of leptomeningeal metastasis (cerebrospinal fluid) to temozolomide
Detailed Summary:
Sponsor: Stanford University
Current Primary Outcome:
- Response rate [ Time Frame: 8 weeks ]
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:
- Initial diagnosis (mass)
- At relapse (mass)
- Evaluate the toxicity suffered during each cycle of temozolamide will be evaluated using the CTCAE v3.0 [ Time Frame: 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Stanford University
Dates:
Date Received: March 25, 2013
Date Started: March 2012
Date Completion:
Last Updated: January 26, 2017
Last Verified: January 2017