Intraocular MelanomaPhase 3NCT00036816
Vaccine Therapy in Treating Patients With Melanoma of the Eye
A Phase 3 study testing MART-1 antigen, NA17-A antigen and gp100 antigen in people with Intraocular Melanoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in 2 countries.
Trial summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye. PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Melanoma
- What is being tested?
- MART-1 antigen, NA17-A antigen and gp100 antigen
- How many people
- 13 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2002to Feb 2003
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of ocular melanoma
- No melanoma of the iris
- Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy
- No more than 5 weeks since the beginning of primary tumor treatment
- Measurable disease
- At least 12.0 mm in largest diameter OR
- At least 6.0 mm in height
- HLA-A2 positive
- No distant metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Hemoglobin at least 9 g/dL
- Neutrophil count at least 2,000/mm^3
- Lymphocyte count at least 700/mm^3
- Platelet count at least 100,000/mm^3
- No bleeding disorder
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 2 times upper limit of normal (ULN)
- Lactate dehydrogenase no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
- Gamma glutamyl transpeptidases no greater than 2 times ULN
- Hepatitis C antibody negative
- Hepatitis B antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Immunologic:
- No clinical immunodeficiency
- No autoimmune diseases
- No inflammatory bowel disease
- No active infection requiring antibiotics
- No multiple sclerosis
Other:
- HIV negative
- No other malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- No other uncontrolled illness
- No psychological, familial, sociological, or geographical conditions that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No other concurrent immunotherapy or biologic therapy
Chemotherapy:
- No concurrent chemotherapy
Endocrine therapy:
- At least 3 weeks since prior steroids
- No concurrent chronic therapy with high doses of corticosteroids (e.g., methylprednisolone at least 12 mg/day)
- Concurrent topical or inhalation steroids allowed
- No concurrent hormonal therapy
Radiotherapy:
- See Disease Characteristics
- Prior proton beam therapy allowed
- Prior brachytherapy without tumor resection allowed
- Recovered from prior radiotherapy
- No prior radiotherapy to the spleen
- No prior pre-enucleation radiotherapy
- No prior ruthenium Ru 106 as primary therapy alone
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Prior transcleral tumor resection allowed
- Recovered from prior surgery
- No prior major organ allograft
- No prior splenectomy
Other:
- No other concurrent investigational drugs
- No concurrent systemic immunosuppressive drugs
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Randomized Phase III Study Of Adjuvant Immunization With The NA17.A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.
Read the detailed description
OBJECTIVES:
- Determine whether adjuvant NA17-A and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse.
- Determine whether this regimen increases survival of these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vaccination with NA17-A and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years.
- Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years.
All patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.
- Conditions
- Intraocular Melanoma
- Being tested
- MART-1 antigen, NA17-A antigen, gp100 antigen, tyrosinase peptide
- Keywords
- ciliary body and choroid melanoma, medium/large size
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MART-1 antigenBiological
NA17-A antigenBiological
gp100 antigenBiological
tyrosinase peptideBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startFeb 2002
- Primary completionFeb 2003
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular MelanomaStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Vincent Brichard, MD, Study chair, Cliniques universitaires Saint-Luc- Université Catholique de LouvainJan U. Prause, MD, Study chair, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036816
- Sponsor's protocol ID
- EORTC-18001 -88001
- Other IDs
- EORTC-18001, EORTC-88001
- Status last verified
- Sep 2012
- First submitted
- 13 May 2002
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study Of Adjuvant Immunization With The NA17.A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse
- ClinicalTrials.gov ID
- NCT00036816
- Acronym / sponsor ID
- EORTC-18001 -88001
- Conditions
- Intraocular Melanoma
- Keywords
- ciliary body and choroid melanoma, medium/large size
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 13 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Feb 2002
- Primary completion
- Feb 2003 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye.
PURPOSE: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who are at high risk for recurrent melanoma of the eye.
Detailed description
OBJECTIVES:
- Determine whether adjuvant NA17-A and melanoma differentiation peptides are effective in decreasing the occurrence of liver metastasis in HLA-A2-positive patients with primary ocular melanoma at high risk of relapse.
- Determine whether this regimen increases survival of these patients.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor size (medium vs large), prior treatment of primary tumor (surgery vs radiotherapy), and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive vaccination with NA17-A and melanoma differentiation peptides (e.g., tyrosinase, Melan-A, and gp100 antigens) subcutaneously and intradermally on days 1, 8, 15, and 22. Patients then receive a vaccination once every 14 days for 4 doses, once every 28 days for 4 doses, once every 56 days for 4 doses, and then once every 3 months for a total of 4 years.
- Arm II: Patients undergo observation only every 3 months for 2 years and then every 6 months for 2 years.
All patients are followed every 3 months for 1 year and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MART-1 antigen | Biological | – |
| NA17-A antigen | Biological | – |
| gp100 antigen | Biological | – |
| tyrosinase peptide | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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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.
Vincent Brichard, MD study chair
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Jan U. Prause, MD study chair
University of Copenhagen
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MART-1 antigen, NA17-A antigen and gp100 antigen in people with Intraocular Melanoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 stopped early (reason given: low accrual). Results are not available in the source record.
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.
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 24 Sep 2012.