Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020475
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-02
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma of the Eye
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of gp100209-217 210M Antigen and MART-126-35 27L Antigen Emulsified in Montanide ISA-51 in Patients With Metastatic Ocular Melanoma
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
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 Combining vaccine therapy with interleukin-2 may be a more effective treatment for metastatic melanoma of the eye
PURPOSE Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in treating patients who have metastatic melanoma of the eye
PURPOSE Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 in treating patients who have metastatic melanoma of the eye
Detailed Description:
OBJECTIVES I Determine the clinical response in patients with metastatic ocular melanoma treated with gp100209-217 210M antigen and MART-126-35 27L antigen emulsified in Montanide ISA-51
II Determine the clinical benefit of interleukin-2 in combination with this vaccine in these patients
PROTOCOL OUTLINE Patients receive vaccine subcutaneously once weekly Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients with progressive disease may receive vaccine SC on day 1 followed by interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL
A total of 15-25 patients will be accrued for this study within 1 year
II Determine the clinical benefit of interleukin-2 in combination with this vaccine in these patients
PROTOCOL OUTLINE Patients receive vaccine subcutaneously once weekly Treatment repeats every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients with progressive disease may receive vaccine SC on day 1 followed by interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses Treatment repeats every 3 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL
A total of 15-25 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| NCI-2910 | None | None | None |
| NCI-01-C-0074 | None | None | None |