Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019682
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2001-07-11
Brief Title:
Aldesleukin With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Multi-Institutional Randomized Study of Immunization With the gp100 209-217 210M Peptide Followed by High Dose IL-2 vs High Dose IL-2 Alone in Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2017-11
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:
This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body Aldesleukin may stimulate a persons white blood cells to kill melanoma cells Vaccines may make the body build an immune response to kill tumor cells It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma
Detailed Description:
PRIMARY OBJECTIVES
I To identify whether the addition of the peptide vaccine to high dose interleukin IL-2 aldesleukin can result in a clinical response rate which may be superior to that found in similar patients treated with high dose IL-2 alone
SECONDARY OBJECTIVES
I To evaluate the toxicity profile of patients treated on this trial according to the regimen received
II To compare the disease freeprogression free survival of patients treated on both arms of the study
III To determine the immunologic response experienced by patients who have received the peptide vaccination as measured by changes in T-cell precursors from before to after treatment
IV To evaluate the quality of life of patients before and after high-dose IL-2
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive aldesleukin intravenously IV over 15 minutes every 8 hours for 12 doses
ARM II Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously SC on day 1 Patients also receive aldesleukin as in Arm I beginning on day 2
In both arms treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses Patients with complete response may receive a maximum of 2 additional courses
After completion of treatment patients are followed up every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
I To identify whether the addition of the peptide vaccine to high dose interleukin IL-2 aldesleukin can result in a clinical response rate which may be superior to that found in similar patients treated with high dose IL-2 alone
SECONDARY OBJECTIVES
I To evaluate the toxicity profile of patients treated on this trial according to the regimen received
II To compare the disease freeprogression free survival of patients treated on both arms of the study
III To determine the immunologic response experienced by patients who have received the peptide vaccination as measured by changes in T-cell precursors from before to after treatment
IV To evaluate the quality of life of patients before and after high-dose IL-2
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive aldesleukin intravenously IV over 15 minutes every 8 hours for 12 doses
ARM II Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously SC on day 1 Patients also receive aldesleukin as in Arm I beginning on day 2
In both arms treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease 3 weeks after completing 2 courses may receive a maximum of 12 additional courses Patients with complete response may receive a maximum of 2 additional courses
After completion of treatment patients are followed up every 3 months for 1 year every 4 months for 1 year every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| T98-0085 | OTHER | CTEP | None |
| NCI-2012-02897 | REGISTRY | None | None |
| CDR0000066963 | None | None | None |
| 99-C-0051 | OTHER | None | None |