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