Uveal MelanomaNCT00596362
Treatment With Intravitreal Avastin for Large Uveal Melanomas
A study testing AVASTIN in people with Uveal Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- AVASTIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 diagnosed with large uveal melanomas who elect to undergo enucleation.
- Patients diagnosed with uveal melanomas with tumor thickness > 10 mm or basal diameter > 16 mm, as measured by ultrasound examination, funduscopic examination, or transillumination.
Who cannot join
- Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
- Patients with history of metastatic cancer (other than melanoma).
- Patients not able to provide consent for the study.
- Patients with clinical or radiographic evidence of extraocular extension of the tumor.
- Patients with a previous history of an adverse reaction to intravitreal injection.
- Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
Show all 9Show fewer
- Patients with intravitreal silicone oil or gas tamponade.
- Patients < 18 years of age.
- Women known to be pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas
The purpose of this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.
- Conditions
- Uveal Melanoma
- Being tested
- AVASTIN
- Keywords
- Melanoma, Eye, Avastin
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVASTINDrug
a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AVASTIN Receives: Drug: AVASTIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease
Measured: At conclusion of study, up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startApr 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Abramson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596362
- Sponsor's protocol ID
- 07-040
- Status last verified
- May 2016
- First submitted
- 8 Jan 2008
- Last updated
- 17 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment With Intravitreal Avastin for Large Uveal Melanomas
- ClinicalTrials.gov ID
- NCT00596362
- Acronym / sponsor ID
- 07-040
- Conditions
- Uveal Melanoma
- Keywords
- Melanoma, Eye, Avastin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 17 Jan 2008 (estimated)
- Results
- Posted 14 Apr 2015
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 this study is to test the safety and effectiveness of Avastin introduced into the inside of the eyeball in causing shrinkage of the uveal melanoma (tumor of the eye). Avastin is an anti-cancer drug specially designed to shrink blood vessels within tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AVASTINAVASTIN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with large uveal melanomas who elect to undergo enucleation.
- Patients diagnosed with uveal melanomas with tumor thickness > 10 mm or basal diameter > 16 mm, as measured by ultrasound examination, funduscopic examination, or transillumination.
Key exclusion criteria (9 listed)
- Cases that do not meet the above criteria for tumor size will be ineligible to participate in the study.
- Patients with history of metastatic cancer (other than melanoma).
- Patients not able to provide consent for the study.
- Patients with clinical or radiographic evidence of extraocular extension of the tumor.
- Patients with a previous history of an adverse reaction to intravitreal injection.
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 |
|---|---|---|
| AVASTINa single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office. | Drug | 1 |
Primary outcome
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume).
Time frame: At conclusion of study, up to 5 days
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease: neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for partial response nor sufficient increase in the sum of the longest diameter of target lesions to qualify for progressive disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
David Abramson, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVASTIN in people with Uveal Melanoma, run by Memorial Sloan Kettering Cancer Center 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 9 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 17 Jun 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Response of Intravitreal Avastin in Causing a Clinically Significant Reduction in Uveal Melanoma Tumor Size (Base Height and Volume). (time frame: At conclusion of study, up to 5 days). 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 17 Jun 2016.