Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033228
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
2002-04-09
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
Mannkind Corporation
Organization:
Mannkind Corporation
Study Overview
Official Title:
A Phase III Pilot Study Of Intranodal Delivery Of A Plasmid DNA Synchrovax SEM Vaccine In Stage IV Melanoma Patients
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 to kill tumor cells Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma
PURPOSE Phase III trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma
Determine the safety and tolerability of this drug in these patients
Determine the immunological response as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment in patients treated with this drug
Determine the clinical response as measured by lactic dehydrogenase levels and radiologic assessment of lesions in patients treated with this drug
OUTLINE This is a multicenter dose-escalation study
Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4 Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment
Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 10 days after the last dose of study drug
PROJECTED ACCRUAL A total of 6-18 patients will be accrued for this study
Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma
Determine the safety and tolerability of this drug in these patients
Determine the immunological response as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment in patients treated with this drug
Determine the clinical response as measured by lactic dehydrogenase levels and radiologic assessment of lesions in patients treated with this drug
OUTLINE This is a multicenter dose-escalation study
Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4 Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment
Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 10 days after the last dose of study drug
PROJECTED ACCRUAL A total of 6-18 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 |
|---|---|---|---|
| CTL-26-35 | None | None | None |