|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 13, 2002 | ||||||||
| Last Updated Date | February 6, 2009 | ||||||||
| Start Date ICMJE | February 2002 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00036816 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Vaccine Therapy in Treating Patients With Melanoma of the Eye | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief 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. |
||||||||
| Detailed Description | 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. |
||||||||
| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||||||
| Condition ICMJE | Intraocular Melanoma | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Immunologic:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Belgium, Denmark | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00036816 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000069325, EORTC-18001, EORTC-88001 | ||||||||
| Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | June 2006 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||