Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005617
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2000-05-02
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2012-07
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 peptides may make the body build an immune response to kill tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or relapsed malignant melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage IV or relapsed malignant melanoma
Detailed Description:
OBJECTIVES
Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma
Determine the immunological and clinical responses in this patient population after this therapy
OUTLINE This is a dose-escalation study
Patients undergo leukapheresis between days -14 to -8 Mononuclear cells are isolated used to generate dendritic cells DC and then pulsed with MART-1 peptide Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0 14 and 28
Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC 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 until death
PROJECTED ACCRUAL A total of 18-24 patients will be accrued for this study
Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma
Determine the immunological and clinical responses in this patient population after this therapy
OUTLINE This is a dose-escalation study
Patients undergo leukapheresis between days -14 to -8 Mononuclear cells are isolated used to generate dendritic cells DC and then pulsed with MART-1 peptide Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0 14 and 28
Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC 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 until death
PROJECTED ACCRUAL A total of 18-24 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 |
|---|---|---|---|
| NCI-H00-0050 | None | None | None |
| UCLA-9508375 | None | None | None |