Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036816
Status:
TERMINATED
Last Update Posted:
2012-09-24
First Post:
2002-05-13
Brief Title:
Vaccine Therapy in Treating Patients With Melanoma of the Eye
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Randomized Phase III Study Of Adjuvant Immunization With The NA17A2 And Melanoma Differentiation Peptites In HLA-A2 Patients With Primary Ocular Melanoma At High Risk Of Relapse
Status:
TERMINATED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-88001 | None | None | None |
| EORTC-18001 | None | None | None |