Choroidal MelanomaPhase 1NCT00765921
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
A Phase 1 study testing ranibizumab in people with Choroidal Melanoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly diagnosed choroidal melanoma undergoing proton therapy
- Tumors >15 mm in largest diameter and/or >5 mm in height
- Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye
Who cannot join
- History of prior treatment for choroidal melanoma
- Pregnancy or lactation
- Presence of diabetic retinopathy
- History of retinal vascular occlusion or other retinal vascular disease
- Active ocular inflammation or history of uveitis in either eye
- History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
- Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
- Concurrent use of systemic anti-VEGF therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.
- Conditions
- Choroidal Melanoma
- Being tested
- ranibizumab
- Keywords
- glaucoma, neovascular, macular edema, eye enucleation, antibodies, monoclonal, radiation oncology
- Medical subject headings
- Uveal Melanoma, Glaucoma, Neovascular, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called rhuFab, Lucentis
Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).
| Study group | Role | What they receive |
|---|---|---|
| 1.0 mg ranibizumab | Experimental | 1.0 mg intravitreal injection given bi-monthly for 22 months Receives: Drug: ranibizumab |
| 0.5 mg ranibizumab | Experimental | 0.5 mg intravitreal injection given bi-monthly for 22 months Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of ocular adverse events and systemic adverse events
Measured: 12 months and 24 months after initial treatment
Secondary outcomes (1)
incidence of radiation-induced complications, vision loss and eye loss
Measured: 12 months and 24 months after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal MelanomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Ivana Kim, M.D., Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765921
- Sponsor's protocol ID
- 07-06-040
- Other IDs
- FVF4384s
- Status last verified
- Dec 2016
- First submitted
- 2 Oct 2008
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT00765921
- Acronym / sponsor ID
- 07-06-040
- Conditions
- Choroidal Melanoma
- Keywords
- glaucoma, neovascular, macular edema, eye enucleation, antibodies, monoclonal, radiation oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2008
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Oct 2008 (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.
The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.0 mg ranibizumab | Experimental | Drug: ranibizumab1.0 mg intravitreal injection given bi-monthly for 22 months |
| 0.5 mg ranibizumab | Experimental | Drug: ranibizumab0.5 mg intravitreal injection given bi-monthly for 22 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with newly diagnosed choroidal melanoma undergoing proton therapy
- Tumors >15 mm in largest diameter and/or >5 mm in height
- Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye
Key exclusion criteria (8 listed)
- History of prior treatment for choroidal melanoma
- Pregnancy or lactation
- Presence of diabetic retinopathy
- History of retinal vascular occlusion or other retinal vascular disease
- Active ocular inflammation or history of uveitis in either eye
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 |
|---|---|---|
| ranibizumabAlso: rhuFab, LucentisRanibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections). | Drug | 0.5 mg ranibizumab, 1.0 mg ranibizumab |
Primary outcome
incidence and severity of ocular adverse events and systemic adverse events
Time frame: 12 months and 24 months after initial treatment
1 secondary outcome
incidence of radiation-induced complications, vision loss and eye loss
Time frame: 12 months and 24 months after initial treatment
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 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Choroidal Melanoma
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Active, not recruitingPhase 3
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
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Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
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A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
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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.
Ivana Kim, M.D. principal investigator
Massachusetts Eye and Ear Infirmary
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 ranibizumab in people with Choroidal Melanoma, run by Massachusetts Eye and Ear Infirmary 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 3 inclusion and 8 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 Dec 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 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 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?
incidence and severity of ocular adverse events and systemic adverse events (time frame: 12 months and 24 months after initial treatment). 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 2 Dec 2016.