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| Sponsored by: |
European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036816 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intraocular Melanoma |
Biological: MART-1 antigen Biological: NA17-A antigen Biological: gp100 antigen Biological: tyrosinase peptide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 |
| Study Start Date: | February 2002 |
OBJECTIVES:
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of ocular melanoma
Disease adequately treated by prior surgery (enucleation or tumorectomy) and/or radiotherapy
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |
| Cliniques Universitaires Saint-Luc | |
| Brussels, Belgium, 1200 | |
| Denmark | |
| University of Copenhagen | |
| Copenhagen, Denmark, 2100 | |
| Study Chair: | Vincent Brichard, MD | Cliniques Universitaires Saint-Luc |
| Study Chair: | Jan U. Prause, MD | University of Copenhagen |
More Information
| Study ID Numbers: | CDR0000069325, EORTC-18001, EORTC-88001 |
| Study First Received: | May 13, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00036816 History of Changes |
| Health Authority: | United States: Federal Government |
|
ciliary body and choroid melanoma, medium/large size |
|
Eye Neoplasms Uveal Melanoma Eye Diseases Adjuvants, Immunologic Melanoma of the Choroid Melanoma Neuroendocrine Tumors |
Ocular Melanoma Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular Melanoma Neuroepithelioma Nevus |
|
Neuroectodermal Tumors Neoplasms Neoplasms by Site Neoplasms by Histologic Type Eye Neoplasms Eye Diseases |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Neuroendocrine Tumors Melanoma |