NCT00460876

Phase I Trial of Periocular Topotecan in Retinoblastoma

Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hospital JP Garrahan · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.

Detailed description

Patients with bilateral retinoblastoma who have relapsed after attempts of conservative therapy with standard regimens such as carboplatin, etoposide, vincristine and external beam radiotherapy who face immediate enucleation of their single remaining eye are eligible for this protocol. Starting dose of topotecan will be 0.5 mg and dose escalation will be done by the accelerated titration method. Any Grade 3 ocular toxicity or grade 4 non ocular toxicity will be designed as the dose limiting toxicity. Grade 2 scleral toxicity will be considered for DLT. In case of grade 2 ocular toxicity or grade 3 systemic toxicity, the escalation dose will be 0.25 mg. Maximal dose will be 2 mg.

Conditions

• Retinoblastoma

Interventions

Type	Name	Description
DRUG	Topotecan

Timeline

• Start date: 2007-03-01
• Primary completion: 2007-12-01
• Completion: 2008-04-01
• First posted: 2007-04-17
• Last updated: 2008-05-02

Locations

1 site across 1 country: Argentina