Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00460876
Status:
COMPLETED
Last Update Posted:
2008-05-02
First Post:
2007-04-13
Brief Title:
Phase I Trial of Periocular Topotecan in Retinoblastoma
Sponsor:
Hospital JP Garrahan
Organization:
Hospital JP Garrahan
Study Overview
Official Title:
Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 face immediate enucleation of their single remaining eye are eligible for this protocol Starting dose of topotecan will be 05 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 025 mg Maximal dose will be 2 mg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None