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

NCT01857752 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-01-30

No results posted yet for this study

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

DRUG

Temozolomide

Sponsors & Collaborators

Principal Investigators

  • Sandra Luna-Fineman · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Guatemala

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857752 on ClinicalTrials.gov