Status:

COMPLETED

Phase I Trial of Periocular Topotecan in Retinoblastoma

Lead Sponsor:

Hospital JP Garrahan

Conditions:

Retinoblastoma

Eligibility:

All Genders

Up to 18 years

Phase:

PHASE1

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 fa...

Eligibility Criteria

Inclusion

  • 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

  • Presence of glaucoma, rubeosis iridis, anterior chamber extension
  • Extraocular disease
  • Adequate follow up impossible for social reasons

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT00460876

Start Date

March 1 2007

End Date

April 1 2008

Last Update

May 2 2008

Active Locations (1)

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1

Hospital JP Garrahan

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