Retinoblastoma
Conditions
Keywords
topotecan, periocular, chemotherapy
Brief 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.
Interventions
DRUGTopotecan
Sponsors
Hospital JP Garrahan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Group Vb (Reese Ellsworth) * Relapsed or progressed after carboplatin-based regimens and external beam radiotherapy * Enucleation of the contralateral eye * Normal renal and liver function
Exclusion criteria
* Presence of glaucoma, rubeosis iridis, anterior chamber extension * Extraocular disease * Adequate follow up impossible for social reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, description of toxicity, pharmacokinetic profile | — |
Countries
Argentina
Outcome results
None listed