Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425672
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2007-01-19
Brief Title:
ONTAK in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase I-II Study of Denileukin Diftitox ONTAK in Patients With Advanced Refractory Breast Cancer
Status:
COMPLETED
Status Verified Date:
2018-11
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 ONTAK may be able to help reduce the type of cells that prevent other types of immune cells from attacking the breast cancer cells
PURPOSE This phase III trial is studying the safety of ONTAK and its possible side effects to see how well it works in treating patients with advanced breast cancer that did not respond to previous treatment
PURPOSE This phase III trial is studying the safety of ONTAK and its possible side effects to see how well it works in treating patients with advanced breast cancer that did not respond to previous treatment
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety of ONTAK infusion in patients with advanced refractory breast cancer
II To evaluate the effect of ONTAK administration on peripheral blood T-regulatory cells
SECONDARY OBJECTIVES
I To evaluate the incidence of IL-2R expression in tumor samples and investigate the correlation of tumor IL-2R expression and tumor response to ONTAK therapy
II To evaluate levels of circulating sIL-2R before and after ONTAK therapy III To evaluate the effect of ONTAK on endogenous tumor specific immunity IV To evaluate the potential anti-tumor effects of ONTAK in patients with advanced refractory breast cancer
OUTLINE
Patients receive ONTAK IV over 1 hour on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
I To evaluate the safety of ONTAK infusion in patients with advanced refractory breast cancer
II To evaluate the effect of ONTAK administration on peripheral blood T-regulatory cells
SECONDARY OBJECTIVES
I To evaluate the incidence of IL-2R expression in tumor samples and investigate the correlation of tumor IL-2R expression and tumor response to ONTAK therapy
II To evaluate levels of circulating sIL-2R before and after ONTAK therapy III To evaluate the effect of ONTAK on endogenous tumor specific immunity IV To evaluate the potential anti-tumor effects of ONTAK in patients with advanced refractory breast cancer
OUTLINE
Patients receive ONTAK IV over 1 hour on days 1-5 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 1 year
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-2010-00800 | REGISTRY | None | None |
| 127 | OTHER | Tumor Vaccine Group | None |