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Phase I Trial of Periocular Topotecan in Retinoblastoma

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: April 17, 2007
Last Update Posted: May 2, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital JP Garrahan
This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.

Condition Intervention Phase
Retinoblastoma Drug: Topotecan Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma

Resource links provided by NLM:

Further study details as provided by Hospital JP Garrahan:

Primary Outcome Measures:
  • Dose limiting toxicity

Secondary Outcome Measures:
  • Response rate, description of toxicity, pharmacokinetic profile

Enrollment: 5
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460876

Hospital JP Garrahan
Buenos Aires, CF, Argentina, C1245AAL
Sponsors and Collaborators
Hospital JP Garrahan
Principal Investigator: Guillermo L Chantada, MD Hospital JP Garrahan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital JP Garrahan
ClinicalTrials.gov Identifier: NCT00460876     History of Changes
Other Study ID Numbers: 14711603062
First Submitted: April 13, 2007
First Posted: April 17, 2007
Last Update Posted: May 2, 2008
Last Verified: April 2008

Keywords provided by Hospital JP Garrahan:

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents