RetinoblastomaPhase 2NCT01151748
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
A Phase 2 study testing Intra-arterial infusion of chemotherapy in people with Retinoblastoma and Eye Cancer, run by Stanford University at 1 site in United States.
Trial summary
Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Retinoblastoma, Eye Cancer
- What is being tested?
- Intra-arterial infusion of chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Mar 2012
- Phase
- Phase 2
- 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
- Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E*).
- Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.
Who cannot join
- Congenital brain anomaly identified on MRI.
- History of systemic coagulopathy.
- Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma
- Conditions
- Retinoblastoma, Eye Cancer
- Being tested
- Intra-arterial infusion of chemotherapy
- Medical subject headings
- Retinoblastoma, Eye Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial infusion of chemotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.
Measured: Follow-up will be performed for one year from treatment date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startSep 2010
- Primary completionMar 2011 (estimated)
- Study completionMar 2012 (estimated)
Why it stopped: Study abandoned; Could not obtain final SRC approval due to IND disagreements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan W Kim, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151748
- Sponsor's protocol ID
- PEDSEYE0001
- Other IDs
- SU-07072009-3000
- Status last verified
- May 2012
- First submitted
- 4 Mar 2010
- Last updated
- 14 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
- ClinicalTrials.gov ID
- NCT01151748
- Acronym / sponsor ID
- PEDSEYE0001
- Conditions
- Retinoblastoma, Eye Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study abandoned; Could not obtain final SRC approval due to IND disagreements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 28 Jun 2010 (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.
Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma
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 (2 listed)
- Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E*).
- Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.
Key exclusion criteria (3 listed)
- Congenital brain anomaly identified on MRI.
- History of systemic coagulopathy.
- Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.
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 |
|---|---|---|
| Intra-arterial infusion of chemotherapy | Procedure or surgery | – |
Primary outcome
Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.
Time frame: Follow-up will be performed for one year from treatment date.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2012.
Related trials for Retinoblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Abemaciclib, to the Usual Chemotherapy Treatment (Gemcitabine) for Soft Tissue Sarcoma
Advanced Dedifferentiated Liposarcoma, Advanced Leiomyosarcoma
RecruitingObservational study
Comprehensive Omics Analysis of Pediatric and Adult Solid Tumors and Establishment of a Repository for Related Biological Studies
Sarcoma, Endocrine Tumors
Active, not recruitingPhase 1
EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults
Pediatric Solid Tumor, Germ Cell Tumor
Enrolling by invitationObservational study
Effect of Treatment Modality on Psychosocial Functioning of Survivors of Unilateral Retinoblastoma
Survivors of Unilateral Retinoblastoma
Active, not recruitingPhase 1
Safety/Efficacy Study of CID-078 in Patients With Advanced Solid Tumor Malignancies
Advanced Solid Tumor, Metastatic Solid Tumor
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.
Jonathan W Kim principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intra-arterial infusion of chemotherapy in people with Retinoblastoma and Eye Cancer, run by Stanford University at 1 site in United States.
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 2 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: withdrawn, as of the sponsor's last update on 14 May 2012. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination. (time frame: Follow-up will be performed for one year from treatment date.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2012.