Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096629
Status:
COMPLETED
Last Update Posted:
2018-04-25
First Post:
2004-11-12
Brief Title:
Vaccine Therapy in Treating Patients With Kidney Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Injection of Renal Cell Carcinoma Patients With Human and Mouse Prostate Specific Membrane Antigen PSMA DNA A Phase I Trial to Assess Safety and Immune Response
Status:
COMPLETED
Status Verified Date:
2018-04
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 make the body build an immune response to kill tumor cells
PURPOSE This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with kidney cancer
PURPOSE This randomized phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with kidney cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of vaccination with human and mouse prostate-specific membrane antigen PSMA DNA in patients with renal cell carcinoma
Determine the maximum tolerated dose of this regimen in these patients
Determine antibody responses to human PSMA in patients treated with this regimen
Secondary
Assess antitumor response in patients treated with this regimen
OUTLINE This is a randomized dose-escalation study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive human prostate-specific membrane antigen PSMA DNA vaccine intramuscularly IM once every 3 weeks for 3 doses doses 1-3 Patients then receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses doses 4-6
Arm II Patients receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses doses 1-3 Patients then receive human PSMA DNA vaccine IM once every 3 weeks for 3 doses doses 4-6
In both arms treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive additional booster vaccinations with the second form of PSMA DNA vaccine received for doses 4-6 every 8 weeks for up to 4 additional doses
Cohorts of 3-6 patients per arm receive escalating doses of human and mouse PSMA DNA vaccine 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 every 3 months for 2 years
Primary
Determine the safety and feasibility of vaccination with human and mouse prostate-specific membrane antigen PSMA DNA in patients with renal cell carcinoma
Determine the maximum tolerated dose of this regimen in these patients
Determine antibody responses to human PSMA in patients treated with this regimen
Secondary
Assess antitumor response in patients treated with this regimen
OUTLINE This is a randomized dose-escalation study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive human prostate-specific membrane antigen PSMA DNA vaccine intramuscularly IM once every 3 weeks for 3 doses doses 1-3 Patients then receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses doses 4-6
Arm II Patients receive mouse PSMA DNA vaccine IM once every 3 weeks for 3 doses doses 1-3 Patients then receive human PSMA DNA vaccine IM once every 3 weeks for 3 doses doses 4-6
In both arms treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease may receive additional booster vaccinations with the second form of PSMA DNA vaccine received for doses 4-6 every 8 weeks for up to 4 additional doses
Cohorts of 3-6 patients per arm receive escalating doses of human and mouse PSMA DNA vaccine 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 every 3 months for 2 years
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-03125 | None | None | None |