CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
HER-2/neu Peptide Vaccine +1 morebiological
Likely dose
HER-2/neu peptide vaccine given intradermally; specific dose not specifiedAI-extracted
Key inclusion· 6
  • ✓Stage IV breast or ovarian cancer in remission or with stable disease on trastuzumab monotherapy
  • ✓HER2 overexpression by IHC 2+ or 3+; if 2+, must have HER2 gene amplification by FISH
  • ✓HLA-A2 positive
  • ✓Off cytotoxic chemotherapy and immunosuppressive agents (including systemic steroids) for at least 30 days prior to enrollment
Key exclusion· 5
  • ✕Simultaneous enrollment on other treatment studies
  • ✕Contraindication to GM-CSF-based vaccine products
  • ✕Cardiac disease including restrictive cardiomyopathy, unstable angina within last 6 months, NYHA class III-IV heart failure, or symptomatic pericardial effusion
  • ✕Active autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194714
NCT00194714Phase 2Completed
CompareCT.gov

Phase I/II Study of Combination Immunotherapy for the Generation of HER-2/Neu (HER2) Specific Cytotoxic T Cells (CTL) in Vivo

University of Washington·interventional·Posted Sep 19, 2005·Updated Jun 6, 2024

In Brief

A Phase 2 clinical trial evaluating HER-2/neu Peptide Vaccine and Laboratory Biomarker Analysis for HER2/Neu Positive and 3 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects of vaccine therapy and to see how well it works in treating patients with stage IV major histocompatibility complex, class I, A2 antigen (HLA-A2) and human epidermal growth factor receptor 2 (HER2) positive breast or ovarian cancer who are receiving trastuzumab. Giving booster vaccines made from HER2 peptides may help increase HER2 specific immunity and immune memory cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHER2/Neu Positive, HLA-A2 Positive Cells Present, Stage IV Breast Cancer, Stage IV Ovarian Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMay 1, 2016
Primary CompletionMar 31, 2021
Study CompletionMay 22, 2023
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 20.8 years ago

Interventions

HER-2/neu Peptide Vaccinebiological

Given ID

Laboratory Biomarker Analysisother

Correlative studies