Phase I Trial of Periocular Topotecan in Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460876
• Other study ID #: 14711603062
• Status: Completed
• Phase: Phase 1
• First received: April 13, 2007
• Last updated: April 30, 2008
• Start date: March 2007
• Est. completion date: April 2008

Study information

• Verified date: April 2008
• Source: Hospital JP Garrahan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• Topotecan

Locations

Country	Name	City	State
Argentina	Hospital JP Garrahan	Buenos Aires	CF

Sponsors (1)

Lead Sponsor	Collaborator
Hospital JP Garrahan

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity			Yes
Secondary	Response rate, description of toxicity, pharmacokinetic profile