At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 8 enrolled
Drug / intervention
Autologous, Lethally Irradiated Breast Cancer Cellsbiological
Likely dose
Not stated in 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.
A Phase Ib Study of Autologous Vaccination With Lethally Irradiated, Autologous Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete GM-CSF Following Preoperative Chemotherapy in Women With Operable Breast Cancer
In Brief
A Phase 1 clinical trial evaluating Autologous, Lethally Irradiated Breast Cancer Cells for Breast Cancer. Completed, enrolled 8 participants across 2 sites.
Detailed Summary
The purpose of this trial is to test the safety of a vaccine made from a patient's own breast cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The vaccine is made by genetically modifying a patient's own tumor cells to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsBrigham and Women's Hospital
Timeline
Phase 1CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedApr 2009
Primary CompletionOct 2011
Study CompletionJun 2021
TodayJul 2026
First PostedApr 13, 2009
Enrollment StartJan 1, 2006
Primary CompletionOct 1, 2011
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.2 years ago
Interventions
Autologous, Lethally Irradiated Breast Cancer Cellsbiological
Vaccination with autologous tumor cells engineered by adenoviral mediated gene transfer to secrete GM-CS