Phase I Trial of Periocular Topotecan in Retinoblastoma

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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