A Phase I-II Study of Tumor Vaccine Following Chemotherapy in Patients With Metastatic Breast Cancer Untreated With Chemo/Radiation in the Previous 18 Months: Vaccine-Induced Bias of T-Cell Repertoire Reconstitution After T-Cell Re-Infusion
Protocol # 03-C-0040
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the study outline?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
Despite the recent development of several new active chemotherapy and hormone therapy drugs, metastatic breast cancer remains, in more than 90% of cases, an incurable disease with conventional first line and salvage treatments, including chemotherapy, hormone therapy, surgery, and radiation therapy. This sad reality makes it reasonable for someone newly diagnosed with metastatic breast cancer to consider up-front treatment on research studies combining experimental treatment with conventional treatments of known potential benefit. New approaches, geared toward cure and not palliation, are clearly needed for the treatment of metastatic breast cancer. This trial studies the efficacy of two cancer vaccines, specifically directed against the breast cancer cells, in addition to conventional treatment.
Who is eligible for this trial? (PDQ)
- Histologically or cytologically confirmed metastatic infiltrating carcinoma of the breast
- More than 18 months since prior chemotherapy or radiotherapy for non-metastatic or for metastatic disease
- CEA positive tumor by standard immunohistochemistry
- Defined as more than 30% of cells staining positive
- Measurable or evaluable disease or no evidence of disease (post surgery)
- No brain metastases
- Hormone receptor status:
- Positive or negative
- 18 and over
- ECOG 0-1
- Absolute neutrophil count > 1,000/mm3; platelet count > 90,000/mm3; no history of abnormal bleeding tendency
- Bilirubin < 1.5 mg/dL (except in patients with Gilbert's disease); AST and ALT < 3 times upper limit of normal; hepatitis B and C negative
- No illness that would preclude study participation
What types of drugs or therapies are being used?
This trial combines the state of the art conventional treatments with an experimental cancer vaccine strategy. The conventional treatments include dose-intensive chemotherapy (see below), surgery and radiation therapy (if indicated), and hormonal therapy. This trial is designed to evaluate the potential efficacy of the two cancer vaccines.
What is the study outline? (PDQ)
- Patients receive immunization with CEA vaccine before chemotherapy
- Patients' own white blood cells (lymphocytes sensitized by the vaccine) are collected and preserved frozen (cyro-preserved) for future use
- Patients receive paclitaxel/cyclophosphamide on days 1 through 3 plus filgrastim (G-CSF) on day 5 for 3 to 5 monthly courses
- Patients then receive doxorubicin/cyclophosphamide for 4 cycles (if not previously treated with an anthracycline)
- Patients receive fludarabine/cyclophosphamide on days 1-4, for one cycle
- Patients receive infusions of their own cryo-preserved lymphocytes
- Patients then receive recombinant vaccines at multiple time points for up to 2.5 years after the start of treatment
What is the frequency and duration of the visits?
- Patients receive chemotherapy, as outlined above, on an outpatient basis. Chemotherapy may be given by the treating oncologist.
- Patients are to be seen at various intervals for disease monitoring and vaccinations over a 3-year time period.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Sportès received his M.D. from the University of Paris, France in 1979. He completed Pediatric Residency in 1984 and Pediatric Hematology-Oncology Fellowship in 1986 at the University of Michigan. In 1988, he completed a 2-year NIH-sponsored scientist exchange program with the bone marrow transplantation unit at Hôpital Saint-Louis in Paris, France. Dr. Sportès has held various positions during his 15-year tenure at NCI. In 1999, he joined NCI's Center for Cancer Research Experimental Transplantation and Immunology Branch as Staff Clinician.
Where is this trial taking place?
NIH Clinical Center
National Institutes of Health
NCI Medical Oncology Branch and Affiliates
Experimental Transplantation and Immunology Branch
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Claude Sportès, M.D.
Principal Investigator
Phone: 301-435-5280
csportes@mail.nih.gov
Referrals:
Zetta Blacklock, R.N., B.S., B.S.N.
Transplant Coordinator
Phone: 301-594-2056
Fax: 301-451-5578
bblacklock@mail.nih.gov
Caroline Stewart, R.N., B.S.N.
Research Nurse
Phone: 301-451-6569
Fax: 301-451-5578
cstewartv@mail.nih.gov
Where can additional information be found?
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