Phase I Trial of Periocular Topotecan in Retinoblastoma

This study has been completed.
Sponsor:
Information provided by:
Hospital JP Garrahan
ClinicalTrials.gov Identifier:
NCT00460876
First received: April 13, 2007
Last updated: April 30, 2008
Last verified: April 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460876

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

No publications provided by Hospital JP Garrahan

Additional 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
Study First Received: April 13, 2007
Last Updated: April 30, 2008
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Hospital JP Garrahan:
topotecan
periocular
chemotherapy

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

ClinicalTrials.gov processed this record on October 22, 2014