Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005956
Status:
COMPLETED
Last Update Posted:
2014-07-09
First Post:
2000-07-05
Brief Title:
Biological Therapy in Treating Patients With Advanced Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
A Pilot Study of Active Immunotherapy With HER2Neu Intracellular Domain ICD Protein-Pulsed Autologous Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2Neu Expressing Malignancies
Status:
COMPLETED
Status Verified Date:
2013-03
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 A persons white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment
PURPOSE Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment
Detailed Description:
OBJECTIVES
Evaluate the immune response of patients with HER2neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2neu intracellular domain protein pulsed autologous dendritic cells
Assess time to recurrence in these patients
OUTLINE Autologous dendritic cells DC are pulsed with HER2neu intracellular domain protein ICD The pulsed DC are administered subcutaneously SQ and intradermally followed by autologous DC mixed with tetanus toxoid TT and autologous DC mixed with keyhole limpet hemocyanin KLH SQ and intradermally on day 1 HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1 Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year or until disease progression
PROJECTED ACCRUAL A total of 6 patients will be accrued for this study over 6 months
Evaluate the immune response of patients with HER2neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2neu intracellular domain protein pulsed autologous dendritic cells
Assess time to recurrence in these patients
OUTLINE Autologous dendritic cells DC are pulsed with HER2neu intracellular domain protein ICD The pulsed DC are administered subcutaneously SQ and intradermally followed by autologous DC mixed with tetanus toxoid TT and autologous DC mixed with keyhole limpet hemocyanin KLH SQ and intradermally on day 1 HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1 Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year or until disease progression
PROJECTED ACCRUAL A total of 6 patients will be accrued for this study over 6 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 |
|---|---|---|---|
| CDR0000067937 | OTHER | NCI | None |
| 6542 | OTHER | None | None |
| 1528 | OTHER | None | None |