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Completed

NCT Number: NCT00460876

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.

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Key information

Conditions

Retinoblastoma Eye Diseases Eye Diseases, Hereditary Eye Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Retinal Diseases Retinal Neoplasms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital JP Garrahan

Buenos Aires, Buenos Aires F.D., C1245AAL, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topotecan

Drug

Primary outcomes

  1. Dose limiting toxicity

Secondary outcomes

  1. Response rate, description of toxicity, pharmacokinetic profile

Sponsors and collaborators

Lead sponsor

Hospital JP Garrahan

Other Gov

Registry information

Official study title

Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Apr 17, 2007
Registry last updated
May 2, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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