Phase I Trial of Periocular Topotecan in Retinoblastoma
This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma|
- Dose limiting toxicity [ Designated as safety issue: Yes ]
- Response rate, description of toxicity, pharmacokinetic profile
|Study Start Date:||March 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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.