Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054535
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-02-05
Brief Title:
Vaccine Therapy and Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment Of Patients With Metastatic Melanoma Using Recombinant Vaccinia And Fowlpox Viruses Encoding The Tyrosine Antigen In Combination With Interleukin-2
Status:
COMPLETED
Status Verified Date:
2004-07
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 that will kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy with interleukin-2 in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the response rate partial response or complete remission in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine fowlpox-tyrosinase vaccine and high-dose interleukin-2
Determine the immunologic response measured by the reactivity of CD4 and CD8 T cells and serum immunoglobulins against tyrosinase and melanoma cells in patients treated with this regimen
OUTLINE Patients receive vaccinia-tyrosinase vaccine intramuscularly IM on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29 Patients then receive high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose Patients with stable disease or a minor mixed or partial response may receive additional courses of fowlpox-tyrosinase vaccine 2 doses and IL-2 as above in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 1 additional course beyond achieving CR
Patients are followed annually for at least 5 years
PROJECTED ACCRUAL A total of 19-35 patients will be accrued for this study within 2 years
Determine the response rate partial response or complete remission in patients with metastatic melanoma treated with vaccinia-tyrosinase vaccine fowlpox-tyrosinase vaccine and high-dose interleukin-2
Determine the immunologic response measured by the reactivity of CD4 and CD8 T cells and serum immunoglobulins against tyrosinase and melanoma cells in patients treated with this regimen
OUTLINE Patients receive vaccinia-tyrosinase vaccine intramuscularly IM on day 1 followed by fowlpox-tyrosinase vaccine IM on days 15 and 29 Patients then receive high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours beginning on day 30 for up to 12 doses and again beginning approximately 3 weeks after the initial dose Patients with stable disease or a minor mixed or partial response may receive additional courses of fowlpox-tyrosinase vaccine 2 doses and IL-2 as above in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 1 additional course beyond achieving CR
Patients are followed annually for at least 5 years
PROJECTED ACCRUAL A total of 19-35 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-6119 | None | None | None |
| NCI-03-C-0080 | None | None | None |