Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398073
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2006-11-09
Brief Title:
Vaccine Therapy in Treating Patients With Stage IIB Stage IIC Stage III or Stage IV Melanoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Injection of AJCC Stage IIB IIC III and IV Melanoma Patients With Mouse gp100 DNA A Pilot Study to Compare Intramuscular Jet Injection With Particle Mediated Delivery
Status:
COMPLETED
Status Verified Date:
2017-01
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 DNA may help the body build an effective immune response to kill tumor cells Giving the vaccine in different ways may make a stronger immune response and kill more tumor cells
PURPOSE This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB stage IIC stage III or stage IV melanoma
PURPOSE This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB stage IIC stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Primary
Evaluate the safety and feasibility of particle-mediated epidermal delivery PMED immunization comprising mouse gp100 plasmid DNA vaccine in patients with stage IIB IIC III or IV melanoma
Compare the immunologic response induced with PMED vs intramuscular jet injection methods of vaccination in these patients
Secondary
Observe patients with measurable tumor for evidence of any antitumor response generated after vaccination
Assess for disease relapse in patients treated with this vaccine
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive mouse gp100 plasmid DNA vaccine by particle-mediated epidermal delivery on days 1 3 5 8 22 24 26 29 43 45 47 50 64 66 68 and 71
Arm II Patients receive mouse gp100 plasmid DNA vaccine by intramuscular jet injection on days 1 3 5 8 22 24 26 29 43 45 47 50 64 66 68 and 71
After completion of study treatment patients are followed periodically for 1 year
Primary
Evaluate the safety and feasibility of particle-mediated epidermal delivery PMED immunization comprising mouse gp100 plasmid DNA vaccine in patients with stage IIB IIC III or IV melanoma
Compare the immunologic response induced with PMED vs intramuscular jet injection methods of vaccination in these patients
Secondary
Observe patients with measurable tumor for evidence of any antitumor response generated after vaccination
Assess for disease relapse in patients treated with this vaccine
OUTLINE This is a randomized pilot study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive mouse gp100 plasmid DNA vaccine by particle-mediated epidermal delivery on days 1 3 5 8 22 24 26 29 43 45 47 50 64 66 68 and 71
Arm II Patients receive mouse gp100 plasmid DNA vaccine by intramuscular jet injection on days 1 3 5 8 22 24 26 29 43 45 47 50 64 66 68 and 71
After completion of study treatment patients are followed periodically for 1 year
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 |
|---|---|---|---|
| MSKCC-06113 | None | None | None |