Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107211
Status:
COMPLETED
Last Update Posted:
2014-09-17
First Post:
2005-04-05
Brief Title:
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A HER-2Neu Pulsed DC1 Vaccine for Patients With DCIS
Status:
COMPLETED
Status Verified Date:
2014-09
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 peptides and a persons white blood cells may help the body build an effective immune response to kill tumor cells Injecting the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells Giving vaccine therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast
PURPOSE This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast
PURPOSE This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility and safety of neoadjuvant ultrasound-guided intranodal vaccine therapy comprising autologous dendritic cells pulsed with recombinant HER2neu peptides in patients with ductal carcinoma in situ of the breast
Determine the sensitization of CD4 and CD8 T cells to HER2neu in patients treated with this vaccine
Determine clinical response in patients treated with this vaccine
Secondary
Correlate post-vaccine sensitization of CD4 and CD8 T cells to HER2neu with clinical response in patients treated with this vaccine
OUTLINE This is a pilot study
Patients undergo leukapheresis over 2-3 hours to obtain lymphocytes and monocytes Monocytes are cultured with sargramostim GM-CSF interleukin-4 interferon gamma and lipopolysaccharides for the production of dendritic cells DC DC are then pulsed with recombinant HER2neu peptides to produce the dendritic cell vaccine Approximately 2 days after leukapheresis patients receive the vaccine intranodally into 2 different lymph nodes by ultrasound guidance once a week for 4 weeks in the absence of unacceptable toxicity Patients then undergo a second leukapheresis to obtain T lymphocytes for immunologic analysis Within 2-3 weeks after completion of vaccine therapy patients undergo lumpectomy or mastectomy AND sentinel lymph node biopsy
After completion of study treatment patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 years
Primary
Determine the feasibility and safety of neoadjuvant ultrasound-guided intranodal vaccine therapy comprising autologous dendritic cells pulsed with recombinant HER2neu peptides in patients with ductal carcinoma in situ of the breast
Determine the sensitization of CD4 and CD8 T cells to HER2neu in patients treated with this vaccine
Determine clinical response in patients treated with this vaccine
Secondary
Correlate post-vaccine sensitization of CD4 and CD8 T cells to HER2neu with clinical response in patients treated with this vaccine
OUTLINE This is a pilot study
Patients undergo leukapheresis over 2-3 hours to obtain lymphocytes and monocytes Monocytes are cultured with sargramostim GM-CSF interleukin-4 interferon gamma and lipopolysaccharides for the production of dendritic cells DC DC are then pulsed with recombinant HER2neu peptides to produce the dendritic cell vaccine Approximately 2 days after leukapheresis patients receive the vaccine intranodally into 2 different lymph nodes by ultrasound guidance once a week for 4 weeks in the absence of unacceptable toxicity Patients then undergo a second leukapheresis to obtain T lymphocytes for immunologic analysis Within 2-3 weeks after completion of vaccine therapy patients undergo lumpectomy or mastectomy AND sentinel lymph node biopsy
After completion of study treatment patients are followed every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| UPCC-704447 | None | None | None |
| UPCC-08102 | None | None | None |