CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
allogeneic GM-CSF-secreting breast cancer vaccine +8 morebiological
Likely dose
trastuzumab 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00847171
NCT00847171Phase 2Completed
CompareCT.gov

A Safety and Bioactivity Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-Secreting Breast Tumor Vaccine for the Treatment of Patients With High Risk/ Metastatic HER-2/Neu- Overexpressing Breast Cancer With No Evidence of Disease

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Feb 19, 2009·Updated Sep 26, 2018

In Brief

A Phase 2 clinical trial evaluating allogeneic GM-CSF-secreting breast cancer vaccine, trastuzumab, and 7 other interventions for Breast Cancer. Completed, enrolled 20 participants across 1 site.

Detailed Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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. Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving trastuzumab together with cyclophosphamide and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 17.4 years ago

Interventions

allogeneic GM-CSF-secreting breast cancer vaccinebiological

Day 0 : Allogeneic GM-CSF-secreting Breast Cancer Vaccine administered as: 12 intradermal injections of a divided total dose of 5 x108 cells.

trastuzumabbiological

Patient HAS received prior Trastuzumab within the last two weeks, give Trastuzumab 2 mg/kg weekly on Day -1 for 5 weeks. Patient has NOT received Trastuzumab within the last two weeks, give On Cycle 1, Day -1 ONLY, Loading dose 4 mg/kg

cyclophosphamidedrug

Cyclophosphamide 200mg/m2 IV in NS 100ml over 30 minutes on Day -1 ONLY. Note: there are no dose modifications for Cyclophosphamide.

flow cytometryother

Samples will be analyzed by flow cytometry using Cell Quest software

immunoenzyme techniqueother

immunohistochemistry staining methodother

Measuring Immune Priming In Vivo By Vaccine Site Biopsies

laboratory biomarker analysisother

pharmacological studyother

biopsyprocedure

skin biopsy to be performed on day 3 and day 7 for cycle 1 and 3 only