Phase I Trial of Periocular Topotecan in Retinoblastoma

• Sponsor: Hospital JP Garrahan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00460876
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma	Drug: Topotecan	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• 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
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Apr 1, 2008

Outcome Measures

Primary Outcome Measures

1. Dose limiting toxicity []

Secondary Outcome Measures

1. Response rate, description of toxicity, pharmacokinetic profile []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Hospital JP Garrahan	Buenos Aires	CF	Argentina	C1245AAL

Sponsors and Collaborators

• Hospital JP Garrahan

Investigators

• Principal Investigator: Guillermo L Chantada, MD, Hospital JP Garrahan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00460876
• Other Study ID Numbers: 14711603062
• First Posted: Apr 17, 2007
• Last Update Posted: May 2, 2008
• Last Verified: Apr 1, 2008

• Keywords provided by , ,: topotecan; periocular; chemotherapy
• Additional relevant MeSH terms: Retinoblastoma; Topotecan

Study Results

No Results Posted as of May 2, 2008