Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023647
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2001-09-13
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
Mannkind Corporation
Organization:
Mannkind Corporation
Study Overview
Official Title:
A Phase I Dose-Ranging Safety Study Using Intranodal Delivery of a Plasmid DNA Synchrotope TA2M in Adult Stage IV Melanoma Patients
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 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 I trial to study the effectiveness of vaccine therapy given directly into a lymph node in treating patients who have stage IV melanoma
PURPOSE Phase I trial to study the effectiveness of vaccine therapy given directly into a lymph node in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES I Determine the safety and tolerability of intranodal Synchrotope TA2M plasmid DNA vaccine in patients with stage IV melanoma II Determine the immune response of patients treated with this vaccine III Determine the clinical response of patients treated with this vaccine
OUTLINE This is dose-escalation multicenter study Patients receive Synchrotope TA2M plasmid DNA vaccine intranodally continuously over 96 hours beginning on days 0 14 28 and 42 Treatment continues for up to 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 8 patients receive escalating doses of Synchrotope TA2M plasmid DNA vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 8 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 16-24 patients will be accrued for this study within 12 months
OUTLINE This is dose-escalation multicenter study Patients receive Synchrotope TA2M plasmid DNA vaccine intranodally continuously over 96 hours beginning on days 0 14 28 and 42 Treatment continues for up to 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 8 patients receive escalating doses of Synchrotope TA2M plasmid DNA vaccine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 8 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 16-24 patients will be accrued for this study within 12 months
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-V01-1666 | None | None | None |
| CTL-207-216 | None | None | None |
| CTL-BB-IND-9146 | None | None | None |
| LAC-USC-10M001 | None | None | None |