RetinoblastomaPhase 1NCT00460876
Phase I Trial of Periocular Topotecan in Retinoblastoma
A Phase 1 study testing Topotecan in people with Retinoblastoma, run by Hospital JP Garrahan at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Topotecan
- How many people
- 5 participants
- Where
- 1 siteArgentina
- Study dates
- Mar 2007to Apr 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Presence of glaucoma, rubeosis iridis, anterior chamber extension
- Extraocular disease
- Adequate follow up impossible for social reasons
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital JP Garrahan
Buenos Aires, Buenos Aires F.D., C1245AAL
About this study
Official title: Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
This is a dose-escalation study aimed to assess the toxicity (and marginally the activity) of periocular topotecan in patients with relapsed-resistant retinoblastoma.
Read the 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.
- Conditions
- Retinoblastoma
- Being tested
- Topotecan
- Keywords
- topotecan, periocular, chemotherapy
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity
Secondary outcomes (1)
Response rate, description of toxicity, pharmacokinetic profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital JP Garrahan
- Sponsor type
- Other government
- Investigators
- Guillermo L Chantada, MD, Principal investigator, Hospital JP Garrahan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460876
- Sponsor's protocol ID
- 14711603062
- Status last verified
- Apr 2008
- First submitted
- 13 Apr 2007
- Last updated
- 2 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18978345
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toxicity and Activity of Periocular Topotecan in Children With Retinoblastoma
- ClinicalTrials.gov ID
- NCT00460876
- Acronym / sponsor ID
- 14711603062
- Conditions
- Retinoblastoma
- Keywords
- topotecan, periocular, chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Hospital JP GarrahanOther government
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of glaucoma, rubeosis iridis, anterior chamber extension
- Extraocular disease
- Adequate follow up impossible for social reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topotecan | Drug | – |
Primary outcome
Dose limiting toxicity
1 secondary outcome
Response rate, description of toxicity, pharmacokinetic profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2008.
- Derived from this study: PubMed 18978345Chantada 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo L Chantada, MD principal investigator
Hospital JP Garrahan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Topotecan in people with Retinoblastoma, run by Hospital JP Garrahan at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460876, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2008.