Status:
COMPLETED
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ma...
Detailed Description
After the patient has given their consent to participate in the trial, a series of tests will be performed to determine if the patient is eligible. These tests may take place up to 21 days before the ...
Eligibility Criteria
Inclusion
- Histologically confirmed Stage IV breast cancer
- Prior banked malignant effusion or significant malignant effusion for tumor harvest or surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan
- Must have received at least one prior regimen of chemotherapy for metastatic disease
- Patients with HER2 positive tumors must have received at least one prior trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab therapy and vaccine treatment concurrently
- Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at any point while on study
- ECOG performance status 0 or 1
- Estimated life expectancy of greater than or equal to 6 months
- 18 years of age or older
- Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy
- Adequate recovery from drug-related toxicities from prior systemic therapies
- Adequate recovery from recent surgery and radiation therapy
- Greater than 6 months since bone marrow or peripheral blood stem cell transplant
Exclusion
- Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days
- Uncontrolled active infection or illness
- Psychiatric illness/social situation that would limit study compliance
- Pregnant or nursing mothers
- Evidence of HIV infection
- Previous participation in an adenovirus-based trial
- Concurrent invasive malignancy
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00317603
Start Date
January 1 2006
End Date
June 1 2021
Last Update
April 1 2022
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115