Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
European Organization for Research and Treatment of Cancer |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00036816 |
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 |
Drug: MART-1 antigen Drug: NA17-A antigen Drug: gp100 antigen Drug: 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.
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:
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 |
Study ID Numbers: | CDR0000069325, EORTC-18001, EORTC-88001 |
Study First Received: | May 13, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00036816 |
Health Authority: | United States: Federal Government |
ciliary body and choroid melanoma, medium/large size |
Ocular melanoma Eye Neoplasms Eye Diseases Melanoma Neuroendocrine Tumors Melanoma of the choroid Neuroectodermal Tumors |
Uveal melanoma Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Intraocular melanoma Neuroepithelioma Nevus |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |