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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

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the doses of lethally irradiated, autologous breast cancer cells engineered by adenoviral mediated gene transfer to secrete GM-CSF that can be manufactured in patients with metastatic breast cancer

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Beth Overmoyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • autologous vaccination
  • GM-CSF
  • adenoviral mediated gene transfer
  • Stage IV breast cancer
  • Breast Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115