At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 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 I Trial of Vaccination With Autologous, Lethally Irradiated Breast Cancer Cells Engineered by Adenoviral Mediated Gene Transfer to Secrete Granulocyte-Macrophage Colony Stimulating Factor in Metastatic Breast Cancer Patients
In Brief
A Phase 1 clinical trial evaluating Autologous, Lethally Irradiated Breast Cancer Cells for Breast Cancer. Completed, enrolled 15 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 2006
Primary CompletionMay 2008
Study CompletionJun 2021
TodayJul 2026
First PostedApr 25, 2006
Enrollment StartJan 1, 2006
Primary CompletionMay 1, 2008
Study CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 20.2 years ago
Interventions
Autologous, Lethally Irradiated Breast Cancer Cellsbiological
Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out