RetinoblastomaPhase 1/2NCT00906113
Intra-arterial Chemotherapy for Children With Retinoblastoma
A Phase 1/2 study testing Intra-arterial injection of melphalan and Injection of melphalan into the ophthalmic artery in people with Retinoblastoma, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Intra-arterial injection of melphalan and Injection of melphalan into the ophthalmic artery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2011to Dec 2017
- Phase
- Phase 1/2
- 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 6 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with retinoblastoma in a single remaining eye with useful vision
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Jacob Pe'er, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Hospital
Jerusalem, 91120
Michael Weintraub, MD, michaelw@hadassah.org.il
Michael Weintraub, MD
About this study
Official title: Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma
Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye.
This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.
- Conditions
- Retinoblastoma
- Being tested
- Intra-arterial injection of melphalan, Injection of melphalan into the ophthalmic artery
- Keywords
- Retinoblastoma
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial injection of melphalanDrug
Injection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses
Injection of melphalan into the ophthalmic arteryDrug
Injection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial melphalan | Experimental | The patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma Receives: Drug: Intra-arterial injection of melphalan; Drug: Injection of melphalan into the ophthalmic artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salvage of eye and vision
Measured: Three years from intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startJun 2011
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
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 Hadassah Medical OrganizationThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Weintraub, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906113
- Sponsor's protocol ID
- 0058-09-HMO
- Status last verified
- Oct 2016
- First submitted
- 19 May 2009
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1-2 Study of Injection of Melphalan Into the Ophthalmic Artery in Children With Retinoblastoma
- ClinicalTrials.gov ID
- NCT00906113
- Acronym / sponsor ID
- 0058-09-HMO
- Conditions
- Retinoblastoma
- Keywords
- Retinoblastoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 May 2009 (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.
Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye.
This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial melphalan | Experimental | Drug: Intra-arterial injection of melphalan, Drug: Injection of melphalan into the ophthalmic arteryThe patients will be treated by injection of chemotherapy (melphalan) into the ophthalmic artery of an eye affected by retinoblastoma |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with retinoblastoma in a single remaining eye with useful vision
Key exclusion criteria (1 listed)
- None
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 injection of melphalanInjection of 5 milligrams of melphalan into the ophthalmic artery once every 3 weeks for a total of 6 courses | Drug | Intra-arterial melphalan |
| Injection of melphalan into the ophthalmic arteryInjection of 5 milligrams of melphalan into the ophthalmic artery in an eye affected by retinoblastoma | Drug | Intra-arterial melphalan |
Primary outcome
Salvage of eye and vision
Time frame: Three years from intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
Jacob Pe'er, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intra-arterial injection of melphalan and Injection of melphalan into the ophthalmic artery in people with Retinoblastoma, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 2016. 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 Israel. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Weintraub, MD (972-2-6777408, michaelw@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salvage of eye and vision (time frame: Three years from intervention). 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 4 Oct 2016.