NCT00460876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 17, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

May 2, 2008

Status Verified

April 1, 2008

Enrollment Period

9 months

First QC Date

April 13, 2007

Last Update Submit

April 30, 2008

Conditions

Retinoblastoma

Keywords

topotecanperiocularchemotherapy

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity

Secondary Outcomes (1)

  • Response rate, description of toxicity, pharmacokinetic profile

Interventions

TopotecanDRUG

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of glaucoma, rubeosis iridis, anterior chamber extension
  • Extraocular disease
  • Adequate follow up impossible for social reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital JP Garrahan

Buenos Aires, Buenos Aires F.D., C1245AAL, Argentina

Location

Related Publications (1)

  • 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.

    PMID: 18978345DERIVED

MeSH Terms

Conditions

Retinoblastoma

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Guillermo L Chantada, MD

    Hospital JP Garrahan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 13, 2007

First Posted

April 17, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

April 1, 2008

Last Updated

May 2, 2008

Record last verified: 2008-04

Locations

AR(1)