Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003897
Status:
COMPLETED
Last Update Posted:
2019-11-19
First Post:
1999-11-01
Brief Title:
Vaccine Therapy With gp100 andor Sargramostim in Treating Patients With Malignant Melanoma
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase I Trial of Immunization Using Particle-Mediated Transfer of Genes for GP-100 and GM-CSF Into Uninvolved Skin of Patients With Melanoma Summary Last Modified 71999
Status:
COMPLETED
Status Verified Date:
2015-07
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 gp100 and sargramostim may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy with gp100 andor sargramostim in treating patients who have malignant melanoma
PURPOSE Phase I trial to study the effectiveness of vaccine therapy with gp100 andor sargramostim in treating patients who have malignant melanoma
Detailed Description:
OBJECTIVES I Determine the safety and toxicity of in vivo particle bombardment with DNA coated gold beads carrying cDNA for gp100 with or without gold beads carrying cDNA for sargramostim GM-CSF into uninvolved skin of patients with melanoma II Estimate the intensity and duration of gp100 transgene expression following these regimens in these patients III Assess local lymphocyte phenotype and systemic lymphocyte function following these regimens in these patients IV Compare gp100 transgene expression as well as local lymphocyte phenotype and systemic lymphocyte function when the cDNA for GM-CSF is administered 3 days before cDNA for gp100 vs on the same day as gp100 administration in these patients V Determine the effect of these regimens on tumor shrinkage histological evidence of tumor inflammation or necrosis or in vitro evidence of antitumor immune reactivity in these patients
OUTLINE This is a dose escalation study Patients are assigned to one of three treatment groups Group I Patients receive particle mediated gene transfer PMGT of gp100 on day 1 to 2 or 4 separate sites One site is biopsied on day 3 A second course is administered on day 22 and one of the sites is biopsied on day 26 Delayed type hypersensitivity DTH is assessed on days 40 and 43 Group II Patients receive PMGT of sargramostim GM-CSF on day 1 to 1-5 separate sites PMGT of gp100 is administered to 2-4 of these same sites on day 4 One of the gp100 sites is biopsied on day 6 A second course is administered beginning on day 22 with one of the sites biopsied on day 29 DTH is assessed on days 40 and 43 Group III Patients receive PMGT of GM-CSF in combination with gp100 on day 1 to 2 or 4 separate sites Courses are administered as in group I Patients who achieve partial or complete response or maintain stable disease may receive another course of therapy Cohorts of 3-6 patients are treated at each dose in each group 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 Patients are followed at 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients are assigned to one of three treatment groups Group I Patients receive particle mediated gene transfer PMGT of gp100 on day 1 to 2 or 4 separate sites One site is biopsied on day 3 A second course is administered on day 22 and one of the sites is biopsied on day 26 Delayed type hypersensitivity DTH is assessed on days 40 and 43 Group II Patients receive PMGT of sargramostim GM-CSF on day 1 to 1-5 separate sites PMGT of gp100 is administered to 2-4 of these same sites on day 4 One of the gp100 sites is biopsied on day 6 A second course is administered beginning on day 22 with one of the sites biopsied on day 29 DTH is assessed on days 40 and 43 Group III Patients receive PMGT of GM-CSF in combination with gp100 on day 1 to 2 or 4 separate sites Courses are administered as in group I Patients who achieve partial or complete response or maintain stable disease may receive another course of therapy Cohorts of 3-6 patients are treated at each dose in each group 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 Patients are followed at 3 6 and 12 months and then annually thereafter
PROJECTED ACCRUAL A total of 18 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 |
|---|---|---|---|
| SMPHPEDIATRICS | OTHER | UW Madison | httpsreporternihgovquickSearchU01CA061498 |
| U01CA061498 | NIH | None | None |
| CO98601 | OTHER | None | None |
| NCI-T98-0045 | None | None | None |
| A536755 | OTHER | None | None |