Trial Information

Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma

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.