Clinical trial · Interventional
Phase I Trial of Periocular Topotecan in Retinoblastoma
Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
NCT00460876CI-TRIAL-00001434completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Retinoblastoma | Retinoblastoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose limiting toxicity
Secondary outcomes (1)
- measure
- Response rate, description of toxicity, pharmacokinetic profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChantada GL, Fandino AC, Carcaboso AM, Lagomarsino E, de Davila MT, Guitter MR, Rose AB, Manzitti J, Bramuglia GF, Abramson DH. A phase I study of periocular topotecan in children with intraocular retinoblastoma. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1492-6. doi: 10.1167/iovs.08-2737. Epub 2008 Oct 31. PMID 18978345