Brief Title
Phase I Trial of Periocular Topotecan in Retinoblastoma
Official Title
Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
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 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Dose limiting toxicity
Secondary Outcome
Response rate, description of toxicity, pharmacokinetic profile
Condition
Retinoblastoma
Intervention
Topotecan
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
March 2007
Completion Date
April 2008
Primary Completion Date
December 2007
Eligibility Criteria
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
Gender
All
Ages
N/A - 18 Years
Accepts Healthy Volunteers
No
Contacts
Guillermo L Chantada, MD, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT00460876
Organization ID
14711603062
Study Sponsor
Hospital JP Garrahan
Study Sponsor
Guillermo L Chantada, MD, Principal Investigator, Hospital JP Garrahan
Verification Date
April 2008