Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019669
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2001-07-11
Brief Title:
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization of Patients With Metastatic Melanoma Using a Recombinant Fowlpox Virus Encoding a GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence
Status:
COMPLETED
Status Verified Date:
2004-08
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 It is not yet known whether combining melanoma vaccine with interleukin-2 is more effective than vaccine therapy alone in treating metastatic melanoma
PURPOSE Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment
PURPOSE Phase II trial to compare the effectiveness of melanoma vaccine and interleukin-2 with that of melanoma vaccine alone in treating patients who have metastatic melanoma that has not responded to previous treatment
Detailed Description:
OBJECTIVES
Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly with or without interleukin-2 IL-2
Compare the immune response in patients before and after treatment with these regimens
Compare the toxicity profile of these regimens in these patients
OUTLINE This is a partially randomized study Patients are randomized to 1 of 3 treatment cohorts
Cohort 1 Patients receive recombinant fowlpox virus encoding gp100 peptide fowlpox vaccine IV once every 4 weeks for up to 4 doses Closed to accrual as of 62102
Cohort 2 Patients receive fowlpox vaccine intramuscularly IM once every 4 weeks for up to 4 doses Closed to accrual as of 62104
Cohort 3 for patients in need of immediate interleukin-2 IL-2 and those with disease progression after treatment in cohorts 1 or 2 Patients receive fowlpox vaccine either IV or IM once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine
NOTE The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2
Expanded cohort 2 open to accrual 71902 Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses Upon disease progression patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine Closed to accrual 12403 In all cohorts 3-4 weeks after the last injection patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy Patients with responding disease may receive repeat vaccinations for up to 8 courses Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3 Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy
PROJECTED ACCRUAL A maximum of 84 patients 24 in cohorts 1 and 2 19-33 in cohort 3 and 27 in expanded cohort 2 will be accrued for this study within 1 year
Compare the clinical response in patients with metastatic melanoma treated with immunization with recombinant fowlpox vaccine administered either intravenously or intramuscularly with or without interleukin-2 IL-2
Compare the immune response in patients before and after treatment with these regimens
Compare the toxicity profile of these regimens in these patients
OUTLINE This is a partially randomized study Patients are randomized to 1 of 3 treatment cohorts
Cohort 1 Patients receive recombinant fowlpox virus encoding gp100 peptide fowlpox vaccine IV once every 4 weeks for up to 4 doses Closed to accrual as of 62102
Cohort 2 Patients receive fowlpox vaccine intramuscularly IM once every 4 weeks for up to 4 doses Closed to accrual as of 62104
Cohort 3 for patients in need of immediate interleukin-2 IL-2 and those with disease progression after treatment in cohorts 1 or 2 Patients receive fowlpox vaccine either IV or IM once every 4 weeks for 4 doses and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine
NOTE The IM route of administration was selected as the preferred route of administration from cohorts 1 and 2
Expanded cohort 2 open to accrual 71902 Patients receive fowlpox vaccine IM once every 4 weeks for up to 4 doses Upon disease progression patients receive fowlpox vaccine as above and IL-2 IV every 8 hours for a maximum of 12 doses beginning 24 hours after fowlpox vaccine Closed to accrual 12403 In all cohorts 3-4 weeks after the last injection patients achieving a complete remission may receive a maximum of an additional 2 courses of therapy Patients with responding disease may receive repeat vaccinations for up to 8 courses Patients with no response or progressive disease in cohorts not receiving IL-2 may be treated with fowlpox vaccine and IL-2 as in cohort 3 Patients who are randomized to receive IL-2 may not receive additional IL-2 therapy
PROJECTED ACCRUAL A maximum of 84 patients 24 in cohorts 1 and 2 19-33 in cohort 3 and 27 in expanded cohort 2 will be accrued for this study within 1 year
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-T98-0088 | None | None | None |
| NCI-99-C-0044 | None | None | None |