Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01355393
Status:
COMPLETED
Last Update Posted:
2020-02-10
First Post:
2011-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Phase I-II Study of HER2 Vaccination With Poly(I) • Poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2019-06
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 randomized phase I/II trial studies the side effects and best dose of rintatolimod when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells that express HER-2/neu. Adjuvant therapies, such as GM-CSF and rintatolimod, are additional cancer treatments given after the primary treatment to lower the risk that the cancer will come back and are one way to help vaccines produce stronger immune responses. Giving vaccine therapy together with rintatolimod and/or GM-CSF may be a safe and effective treatment for breast cancer.
Detailed Description:
OBJECTIVES:
I. To choose the most promising (maximum biologic dose \[MBD\]) of five different doses (4, 20, 79, 495 and 2000 mcg) of Ampligen (rintatolimod) administered intradermally (i.d.) as an adjuvant with HER2 vaccination, with respect to toxicity and incidence and magnitude of immune response.
II. To determine, using MBD of Ampligen (defined in first primary aim), whether Ampligen when given with GM-CSF as a combined adjuvant strategy with HER2 vaccination increases both the incidence and magnitude of HER2 Th1 immunity as compared to the standard GM-CSF adjuvant strategy.
OUTLINE: This will be a phase I-II randomized two-stage HER2 vaccine study in breast cancer patients.
STUDY STAGE I: There are five groups of patients randomized to 1 of 5 arms with each arm receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses) given i.d.
STUDY STAGE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive the synthetic HER-2/neu peptide vaccine admixed with rintatolimod given i.d.
ARM II: 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF and the other 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF in addition to rintatolimod (dose set by Stage I group that had the most active response) given i.d.
In both study stages, treatment repeats every month for up to 3 months in the absence of disease progression or unacceptable toxicity.
After completion of last vaccine, patients are followed up at 1 and 12 months.
I. To choose the most promising (maximum biologic dose \[MBD\]) of five different doses (4, 20, 79, 495 and 2000 mcg) of Ampligen (rintatolimod) administered intradermally (i.d.) as an adjuvant with HER2 vaccination, with respect to toxicity and incidence and magnitude of immune response.
II. To determine, using MBD of Ampligen (defined in first primary aim), whether Ampligen when given with GM-CSF as a combined adjuvant strategy with HER2 vaccination increases both the incidence and magnitude of HER2 Th1 immunity as compared to the standard GM-CSF adjuvant strategy.
OUTLINE: This will be a phase I-II randomized two-stage HER2 vaccine study in breast cancer patients.
STUDY STAGE I: There are five groups of patients randomized to 1 of 5 arms with each arm receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different doses) given i.d.
STUDY STAGE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive the synthetic HER-2/neu peptide vaccine admixed with rintatolimod given i.d.
ARM II: 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF and the other 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF in addition to rintatolimod (dose set by Stage I group that had the most active response) given i.d.
In both study stages, treatment repeats every month for up to 3 months in the absence of disease progression or unacceptable toxicity.
After completion of last vaccine, patients are followed up at 1 and 12 months.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-00658 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 7425/133 | None | None | View | |
| 133 [Tumor Vaccine Group] | None | None | View | |
| 7425 | OTHER | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |