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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052351 |
Purpose
RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells.
PURPOSE: Randomized clinical trial to study the effectiveness of vaccine therapy plus sargramostim and combination chemotherapy in treating women who have undergone surgery for stage II or stage III breast cancer that has spread to the lymph nodes.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine Biological: sargramostim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Radiation: radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Pilot Study Of Sequential Vaccinations With Recombinant Vaccinia-CEA(6D)-TRICOM, And Recombinant Fowlpox-CEA(6D)-TRICOM (B7.1/ICIAM-1/LFA-3) With Sargramostim (GM-CSF), In Conjunction With Standard Adjuvant Chemotherapy In High Risk Breast Cancer Patients Status Post Surgery With 4+ Or More Lymph Nodes And CEA Expressing Tumors |
| Study Start Date: | September 2002 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
Fowlpox-CEA-TRICOM: Patients are treated on 1 of the following schedules:
Patients with hormone-receptor positive tumors receive oral tamoxifen for 5 years beginning on approximately week 32.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 28 (14 per treatment arm) patients will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the breast
Carcinoembryonic antigen (CEA) expression, as indicated by 1 of the following:
Must have received prior vaccinia for smallpox immunization with 1 of the following as evidence:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
LVEF at least 45% by echocardiogram or MUGA if either of the following are true:
Immunologic
No autoimmune disease such as any of the following:
Other
Must be able to avoid close household contact with the following during and for 2 weeks after vaccinations:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent steroids except the following:
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Philip M. Arlen, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000258196, NCI-03-C-0005, NCI-5191 |
| Study First Received: | January 24, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00052351 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer |
|
Metronidazole Anti-Infective Agents Antiprotozoal Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Antibiotics, Antineoplastic Antiparasitic Agents Neoplasms by Site Therapeutic Uses Alkylating Agents Breast Diseases Skin Diseases |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |