- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00317603
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
March 30, 2022 updated by: Ana C Garrido-Castro, Dana-Farber Cancer Institute
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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 surgery to remove a tumor sample or cancer-containing fluid, which will be used to create the vaccines.
The tumor cells or fluid is then brought to a special, certified laboratory where the vaccine is made.
Specially trained laboratory technicians then use a method known as adenoviral mediated gene transfer, which adds a new gene to the cancer cells.
This gene causes the cells to make GM-CSF, a powerful hormone that stimulates the immune system.
The cells are then given radiation so that they will not grow.
Participants will start receiving vaccine on day 1, 8, 15, 29, and then every two weeks until the supply of vaccine has run out.
The amount of the vaccine depends upon the total amount of cells that are obtained from the breast cancer tumor or fluid.
Each time the patient is vaccinated, they will be given injections that will be placed underneath the skin.
A different place will be used for each injection.
If there are enough cells from the patient's tumor sample, the patient will be given an injection of non-transduced irradiated cells (the gene was not added) .
These cells will help to measure how the patient's immune system is reacting to the tumor cells.
This is called Delayed-Type Hypersensitivity (DTH).
With vaccine #1 and #5, the patient will also receive a DTH injection.
Two to three days after the vaccine and DTH injection, skin biopsies will be taken of both sites.
At week 10 in the study treatment, or earlier if necessary, the patient will have a chest, abdomen, and pelvic CT scan to determine if the vaccine therapy has had an effect on their disease.
A brain MRI will be performed if there were any abnormalities on the first brain MRI or if new symptoms have developed.
Patients may participate in this study until one of the following happens: All vaccine created from the tumor has been given to the patient; the patient's disease worsens; the patient experiences an unacceptable and/or harmful side effect; the patient is unable to follow the study plan; or the patient's doctor feels it is no longer in the best interest of the patient to continue.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vaccine
Vaccinations will be administered on days 1,8,15 and every two weeks thereafter until the supply of vaccine has been exhausted or the patient is removed from study. As indicated in 5.2.5, vaccine cell dosage will be approximately 1x10 7 , 4x10 6 , 1x10 6 , or 1x10 5 depending on the final cell yield. |
Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimum Number of Vaccine Doses Created Using Participant Tumor Sample
Time Frame: Vaccine doses created and banked soon after registration, up to 8 days.
|
Tumor samples were obtained via malignant effusion or a surgically accessible tumor nodule of 2 cm in greatest diameter.
Tumor cells were processed to single cell suspension and transduced with adenoviral vector encoding human Granulocyte-macrophage colony-stimulating factor (GM-CSF).
Then, the cells washed extensively and irradiated with 10,000 cGy.
Over the next 14 days, sterility cultures were tested for endotoxin and mycoplasma contamination.
Individual vaccine cell dose and number varied depending on the final cell yield from vaccine production.
The minimal dose was 1 x 10^5 cells and the maximal dose was 1 x 10^7 cells.
|
Vaccine doses created and banked soon after registration, up to 8 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Grade 3 or Higher Adverse Events
Time Frame: Up to 58 Months
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Number of participants with grade 3 or higher adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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Up to 58 Months
|
Number of Participants With RECIST Criteria Responses
Time Frame: Up to 14 Years
|
Clinical outcomes as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
For target lesions, complete response (CR) is complete disappearance of all target lesions and partial response (PR) is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD.
Progressive disease (PD) is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions.
Stable disease (SD) is defined as any condition not meeting the above criteria.
|
Up to 14 Years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Beth Overmoyer, MD, Dana-Farber Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2006
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
April 21, 2006
First Submitted That Met QC Criteria
April 21, 2006
First Posted (Estimate)
April 25, 2006
Study Record Updates
Last Update Posted (Actual)
April 1, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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