Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019175
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2001-07-11
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Recurrent Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE I TRIAL IN PATIENTS WITH METASTATIC MELANOMA OF IMMUNIZATION WITH A RECOMBINANT FOWLPOX VIRUS ENCODING THE GP100 MELANOMA ANTIGEN
Status:
COMPLETED
Status Verified Date:
2003-04
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 made from an antigen combined with a modified virus may make the body build an immune response to kill tumor cells Interleukin-2 may stimulate a persons white blood cells to kill melanoma cells Combining vaccine therapy with interleukin-2 may kill more tumor cells
PURPOSE Phase I trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have recurrent metastatic melanoma that has not responded to previous therapy
PURPOSE Phase I trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have recurrent metastatic melanoma that has not responded to previous therapy
Detailed Description:
OBJECTIVES I Evaluate the toxicity immunologic reactivity and possible therapeutic efficacy of immunization with recombinant fowlpox virus encoding the gp100 melanoma antigen administered alone or with interleukin-2 in patients with metastatic melanoma
OUTLINE This is a dose-escalation study Patients receive recombinant fowlpox virus encoding the gp100 melanoma antigen FPV-gp100 IV or intramuscularly to rotating sites or fowlpox virus encoding modified gp100 melanoma antigen IV every 2 weeks for 4 vaccinations Treatment continues for a maximum of 2 courses in the absence of disease progression Cohorts of 3-9 patients receive escalating doses of FPV-gp100 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity Patients in 3 of 5 cohorts also receive interleukin-2 IL-2 within 12 hours of FPV-gp100 One cohort receives IL-2 subcutaneously daily on days 1-5 and days 8-12 A second cohort receives low-dose IL-2 IV over 15 minutes every 8 hours on days 2-8 A third cohort receives high-dose IL-2 IV over 15 minutes every 8 hours on days 2-6 Patients in cohorts 4 and 5 receive FPV-gp100 alone and if no response is observed after 2 courses may receive 2 courses of IL-2 alone every 8 hours for 5 days approximately 2 weeks apart A separate cohort of 3-9 patients receives modified FPV-gp100 If no response is observed after 2 courses IL-2 may be administered as in cohorts 4 and 5 Patients are followed at 28 days after the second immunization with FPV-gp100
PROJECTED ACCRUAL A maximum of 91 patients will be accrued for this study
OUTLINE This is a dose-escalation study Patients receive recombinant fowlpox virus encoding the gp100 melanoma antigen FPV-gp100 IV or intramuscularly to rotating sites or fowlpox virus encoding modified gp100 melanoma antigen IV every 2 weeks for 4 vaccinations Treatment continues for a maximum of 2 courses in the absence of disease progression Cohorts of 3-9 patients receive escalating doses of FPV-gp100 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity Patients in 3 of 5 cohorts also receive interleukin-2 IL-2 within 12 hours of FPV-gp100 One cohort receives IL-2 subcutaneously daily on days 1-5 and days 8-12 A second cohort receives low-dose IL-2 IV over 15 minutes every 8 hours on days 2-8 A third cohort receives high-dose IL-2 IV over 15 minutes every 8 hours on days 2-6 Patients in cohorts 4 and 5 receive FPV-gp100 alone and if no response is observed after 2 courses may receive 2 courses of IL-2 alone every 8 hours for 5 days approximately 2 weeks apart A separate cohort of 3-9 patients receives modified FPV-gp100 If no response is observed after 2 courses IL-2 may be administered as in cohorts 4 and 5 Patients are followed at 28 days after the second immunization with FPV-gp100
PROJECTED ACCRUAL A maximum of 91 patients will be accrued for this study
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-T94-0139N | None | None | None |
| NCI-96-C-0121 | None | None | None |