Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 7:03 AM
Study NCT ID:
NCT00561756
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2007-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Treating Patients With Recurrent B-Cell Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Study Overview
Official Title:
Phase I Trial to Assess Safety and Immunogenicity of Xenogeneic CD20 DNA Vaccination With Patients With B-Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2015-11
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 mouse DNA may help the body build an effective immune response to kill cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma.
PURPOSE: This phase I trial is studying the side effects and best dose of mouse DNA vaccine in treating patients with recurrent B-cell lymphoma.
Detailed Description:
OBJECTIVES:
Primary
* To evaluate the safety and feasibility of intramuscular DNA vaccination with a plasmid DNA vector expressing the mouse extracellular domain of CD20, namely pINGmminiCD20. Doses of pING-mminiCD20 will be escalated by group to determine the optimal biological dose.
Secondary
* To evaluate antibody and T-cell responses to CD20 after vaccination.
* To observe patients for evidence of any antitumor response generated after vaccination.
OUTLINE: The entire immunization schedule comprises five injections administered every three weeks (for a total of approximately four and one half months). After the second injection, blood will be drawn for assessment of antibody and T-cell responses. After the fifth and final injection, blood will again be drawn for assessment of antibody and T-cell responses.
Primary
* To evaluate the safety and feasibility of intramuscular DNA vaccination with a plasmid DNA vector expressing the mouse extracellular domain of CD20, namely pINGmminiCD20. Doses of pING-mminiCD20 will be escalated by group to determine the optimal biological dose.
Secondary
* To evaluate antibody and T-cell responses to CD20 after vaccination.
* To observe patients for evidence of any antitumor response generated after vaccination.
OUTLINE: The entire immunization schedule comprises five injections administered every three weeks (for a total of approximately four and one half months). After the second injection, blood will be drawn for assessment of antibody and T-cell responses. After the fifth and final injection, blood will again be drawn for assessment of antibody and T-cell responses.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MSKCC-07100 | None | None | View |