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:

  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

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:

    1. Initial diagnosis (mass)
    2. 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