Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003568
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
1999-11-01
Brief Title:
Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
University of Illinois at Chicago
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide g209-217210M With Hight Dose Interleukin-2 IL-2 in HLA-A21Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2005-11
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:
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 Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma
PURPOSE Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Define the antitumor activity of gp100209-217 210M a melanoma peptide derived from gp100 mixed with Montanide ISA-51 in combination with high-dose interleukin-2 IL-2 administered by various schedules in patients with advanced melanoma
Examine the effect of the addition of gp100209-217 210M peptide vaccine to high-dose IL-2 on the toxicity of the treatment in these patients
Define the induction of T-cell responses to gp100209-217 210M peptide and its gp100 parent protein by ELISA with interferon gamma production or CTL precursor frequencies in these patients after the initial course of treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to prior therapy adjuvant interferon vs chemotherapy for advanced disease vs both vs none ECOG performance status 0 vs 1 and number of organ sites involved 1 vs more than 1 Patients are randomized into 1 of 3 treatment arms Arm III closed to accrual as of 11301998
Arm I Patients receive vaccination comprising gp100209-217 210M peptide mixed with Montanide ISA-51 subcutaneously on days 1 22 43 and 64 Patients also receive high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours on days 2-6 and 16-20
Arm II Patients receive vaccination as in arm I on days 1 22 43 and 64 Patients also receive high-dose IL-2 as in arm I on days 44-48 and 60-64 Patients who demonstrate rapid visible disease progression during the initial 4 weeks of therapy while maintaining good performance status may begin high-dose IL-2 on day 23
Arm III closed to accrual as of 11301998 Patients receive vaccination as in arm I on day 1 and then high-dose IL-2 as in arm I on day 2 Patients with nonhematologic toxicity may only receive vaccination on weeks 4 7 and 10 Other patients may also receive IL-2 beginning on day 2 of each treatment week 4 7 and 10 for up to 14 doses
Patients in each arm may receive up to a total of 3 courses of treatment
Patients are followed until death
PROJECTED ACCRUAL Approximately 90 patients 25 patients for arms I and II and 40 patients for arm III arm III closed to accrual as of 11301998 will be accrued for this study within 12-18 months
Define the antitumor activity of gp100209-217 210M a melanoma peptide derived from gp100 mixed with Montanide ISA-51 in combination with high-dose interleukin-2 IL-2 administered by various schedules in patients with advanced melanoma
Examine the effect of the addition of gp100209-217 210M peptide vaccine to high-dose IL-2 on the toxicity of the treatment in these patients
Define the induction of T-cell responses to gp100209-217 210M peptide and its gp100 parent protein by ELISA with interferon gamma production or CTL precursor frequencies in these patients after the initial course of treatment
OUTLINE This is a randomized multicenter study Patients are stratified according to prior therapy adjuvant interferon vs chemotherapy for advanced disease vs both vs none ECOG performance status 0 vs 1 and number of organ sites involved 1 vs more than 1 Patients are randomized into 1 of 3 treatment arms Arm III closed to accrual as of 11301998
Arm I Patients receive vaccination comprising gp100209-217 210M peptide mixed with Montanide ISA-51 subcutaneously on days 1 22 43 and 64 Patients also receive high-dose interleukin-2 IL-2 IV over 15 minutes every 8 hours on days 2-6 and 16-20
Arm II Patients receive vaccination as in arm I on days 1 22 43 and 64 Patients also receive high-dose IL-2 as in arm I on days 44-48 and 60-64 Patients who demonstrate rapid visible disease progression during the initial 4 weeks of therapy while maintaining good performance status may begin high-dose IL-2 on day 23
Arm III closed to accrual as of 11301998 Patients receive vaccination as in arm I on day 1 and then high-dose IL-2 as in arm I on day 2 Patients with nonhematologic toxicity may only receive vaccination on weeks 4 7 and 10 Other patients may also receive IL-2 beginning on day 2 of each treatment week 4 7 and 10 for up to 14 doses
Patients in each arm may receive up to a total of 3 courses of treatment
Patients are followed until death
PROJECTED ACCRUAL Approximately 90 patients 25 patients for arms I and II and 40 patients for arm III arm III closed to accrual as of 11301998 will be accrued for this study within 12-18 months
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-T98-0027 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066634 | REGISTRY | None | None |