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Phase I Trial of Periocular Topotecan in Retinoblastoma

NCT ID: NCT00460876

Last Updated: 2008-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Retinoblastoma

Keywords

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topotecan periocular chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital JP Garrahan

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Guillermo L Chantada, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital JP Garrahan

Locations

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Hospital JP Garrahan

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Countries

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Argentina

References

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Chantada GL, Fandino AC, Carcaboso AM, Lagomarsino E, de Davila MT, Guitter MR, Rose AB, Manzitti J, Bramuglia GF, Abramson DH. A phase I study of periocular topotecan in children with intraocular retinoblastoma. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1492-6. doi: 10.1167/iovs.08-2737. Epub 2008 Oct 31.

Reference Type DERIVED
PMID: 18978345 (View on PubMed)

Other Identifiers

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14711603062

Identifier Type: -

Identifier Source: org_study_id