Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019214
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:
Phase III Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100
Status:
COMPLETED
Status Verified Date:
2005-01
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 white blood cells treated with antigens may make the body build an immune response to kill melanoma cells Interleukin-2 may stimulate a persons white blood cells to kill tumor cells Combining vaccine therapy with interleukin-2 may kill more melanoma cells
PURPOSE This phase III trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy
PURPOSE This phase III trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy
Detailed Description:
OBJECTIVES
Evaluate the toxicity immunologic reactivity and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma
OUTLINE This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens
Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens either intralymphatically every 4 weeks for 2 doses or IV every 3 weeks for 4 doses Some patients also receive interleukin-2 subcutaneously or IV over 3-5 days beginning 24 hours after immunization
Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Subsequent cohorts receive cells with or without interleukin-2 One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine
One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses Patients with stable disease or who achieve minor mixed or partial response may be retreated
Patients with stable or responding disease undergo a second course of vaccination Patients who completed treatment with vaccine alone and have stable disease progressive disease disease progression after a response or a partial response with no further improvement may receive 2 additional courses
PROJECTED ACCRUAL A total of 10-42 patients will be accrued for this study
Evaluate the toxicity immunologic reactivity and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma
OUTLINE This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens
Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens either intralymphatically every 4 weeks for 2 doses or IV every 3 weeks for 4 doses Some patients also receive interleukin-2 subcutaneously or IV over 3-5 days beginning 24 hours after immunization
Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Subsequent cohorts receive cells with or without interleukin-2 One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine
One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses Patients with stable disease or who achieve minor mixed or partial response may be retreated
Patients with stable or responding disease undergo a second course of vaccination Patients who completed treatment with vaccine alone and have stable disease progressive disease disease progression after a response or a partial response with no further improvement may receive 2 additional courses
PROJECTED ACCRUAL A total of 10-42 patients will be accrued for this study
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-T96-0046N | None | None | None |
| NCI-97-C-0046 | None | None | None |
| NCI-97-C-0019 | None | None | None |