Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228358
Status:
COMPLETED
Last Update Posted:
2014-11-11
First Post:
2005-09-13
Brief Title:
Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patients Own T Cells in the Laboratory in Treating Patients With HER-2Neu Overexpressing Metastatic Breast Cancer Ovarian Cancer or Non-Small Cell Lung Cancer Previously Treated With HER-2Neu Vaccine
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Phase I Study of Infusion of HER-2Neu Specific T Cells in Patients With Advanced Stage HER-2Neu Expressing Cancers Who Have Received a HER-2Neu Vaccine
Status:
COMPLETED
Status Verified Date:
2014-11
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:
This phase I trial studies the safety and the ability to expand laboratory-treated T cells when given together with cyclophosphamide or denileukin diftitox in treating patients with human epidermal growth factor receptor HER-2neu overexpressing metastatic breast cancer ovarian cancer or non-small cell lung cancer previously treated with HER-2neu vaccine Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells from growing Drugs used in chemotherapy such as cyclophosphamide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapy such as denileukin diftitox may stimulate the immune system in different ways and stop tumor cells from growing Giving laboratory-treated T cells together with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To assess the feasibility of expanding HER2 specific T cells ex vivo for infusion into subjects who have advanced HER2 overexpressing cancer
II To assess the toxicity associated with infusing autologous HER2 specific T cells into patients using either a single dose of cyclophosphamide or ONTAK denileukin diftitox prior to T cell infusion
SECONDARY OBJECTIVES
I To investigate to what extent HER2 specific T cell immunity can be boosted in individuals treated with a single dose of cyclophosphamide of ONTAK followed by infusion of autologous HER2 specific T cells
II To investigate the potential anti-tumor effects of HER2 specific T cells in patients with HER2 overexpressing advanced-stage cancers
III To evaluate how long tumor antigen specific T cell immune augmentation persists in vivo after a single dose of cyclophosphamide or ONTAK followed by infusion of autologous HER2 specific T cells
OUTLINE This is a dose-escalation study of ex vivo-expanded HER2-specific T cells Patients are assigned to 1 of 2 treatment groups
GROUP A Patients receive low-dose cyclophosphamide intravenously IV on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on days 1 10 and 20
GROUP B Patients receive ONTAK denileukin diftitox IV over 1 hour on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on days 1 10 and 20
After completion of study treatment patients are followed periodically
I To assess the feasibility of expanding HER2 specific T cells ex vivo for infusion into subjects who have advanced HER2 overexpressing cancer
II To assess the toxicity associated with infusing autologous HER2 specific T cells into patients using either a single dose of cyclophosphamide or ONTAK denileukin diftitox prior to T cell infusion
SECONDARY OBJECTIVES
I To investigate to what extent HER2 specific T cell immunity can be boosted in individuals treated with a single dose of cyclophosphamide of ONTAK followed by infusion of autologous HER2 specific T cells
II To investigate the potential anti-tumor effects of HER2 specific T cells in patients with HER2 overexpressing advanced-stage cancers
III To evaluate how long tumor antigen specific T cell immune augmentation persists in vivo after a single dose of cyclophosphamide or ONTAK followed by infusion of autologous HER2 specific T cells
OUTLINE This is a dose-escalation study of ex vivo-expanded HER2-specific T cells Patients are assigned to 1 of 2 treatment groups
GROUP A Patients receive low-dose cyclophosphamide intravenously IV on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on days 1 10 and 20
GROUP B Patients receive ONTAK denileukin diftitox IV over 1 hour on day -1 and 3 escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on days 1 10 and 20
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| NCI-2009-01547 | REGISTRY | CTRP Clinical Trial Reporting Program | None |