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Phase II Randomized Pilot Study of Sequential Vaccinia-CEA-TRICOM Vaccine, Fowlpox-CEA-TRICOM Vaccine, and Sargramostim (GM-CSF) With Standard Adjuvant Chemotherapy in Women With High-Risk Stage II or III Breast Cancer
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase II
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Treatment
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Completed
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18 and over
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NCI
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NCI-03-C-0005 NCI-5191, 5191, NCT00052351
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Objectives - Compare the immunological effects of 2 different schedules of vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF) administered with standard adjuvant chemotherapy in women with high-risk stage II or III breast cancer.
- Compare the safety of these regimens in these patients.
- Determine the feasibility of obtaining determinations of CD4 response in patients treated with these regimens.
- Compare disease-free survival of patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma of the breast
- Stage II or III
- At least 4 positive lymph nodes
- No inflammatory ductal carcinoma
- No positive lymph nodes by immunohistochemistry only
- Carcinoembryonic antigen (CEA) expression, as indicated by 1 of the following:
- At least 30% of tumor stains for CEA on immunohistochemistry
- Elevated serum CEA (greater than 5 ng/mL) anytime during disease course
- Must be HLA-A2 positive
- Must have received prior vaccinia for smallpox immunization with 1 of the following as evidence:
- If age 25 and under, physician certification of prior vaccination
- If over age 25, patient recollection and vaccination-site scar
- Any age, detectable anti-vaccinia antibodies
- No metastases by CT scan of chest, abdomen, and pelvis and a bone scan
- Hormone receptor status:
- Estrogen receptor status and progesterone receptor status known
Prior/Concurrent Therapy:
Biologic therapy - See Disease Characteristics
Chemotherapy - No prior doxorubicin, cyclophosphamide, or paclitaxel
Endocrine therapy - No concurrent steroids except the following:
- Topical steroids
- Inhaled steroids for moderate asthma
- Dexamethasone prior to taxanes
Radiotherapy - No prior radiotherapy to more than 50% of the lymph nodes
Surgery - At least 2 weeks since prior surgery and recovered
- No prior splenectomy
Other - No other concurrent anti-tumor therapies
Patient Characteristics:
Age Sex Menopausal status: Performance status Life expectancy Hematopoietic - WBC at least 3,000/mm3
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 1.5 times ULN
- Hepatitis B and C negative
Renal - Creatinine no greater than 1.5 mg/dL
OR - Creatinine clearance greater than 60 mL/min
- No proteinuria
OR - Protein less than 1,000 mg per 24-hour urine collection
- No hematuria
- No abnormal sediment
Cardiovascular - LVEF at least 45% by echocardiogram or MUGA if either of the following are true:
- History of cardiac disease
- Received prior cardiotoxic chemotherapy
Immunologic - No evidence of immunocompromised status
- No autoimmune disease such as any of the following:
- Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
- Systemic lupus erythematosus
- Sjogren's syndrome
- Scleroderma
- Myasthenia gravis
- Goodpasture syndrome
- Addison's disease
- Hashimoto's thyroiditis
- Active Graves' disease
- No active or prior eczema or other eczematoid skin disorders
- No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
- HIV negative
- No active infection within the past 3 days
- No allergy to eggs
- No history of allergy or untoward reaction to prior vaccination with vaccinia
virus
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other serious illness
- No other malignancy within the past 3 years except squamous cell or basal
cell skin cancer
- No history of seizures, encephalitis, or multiple sclerosis
- No active inflammatory bowel disease
- Must be able to avoid close household contact with the following during and for 2
weeks after vaccinations:
- Persons with active or prior eczema or other eczematoid skin disorders
- Persons with any other acute, chronic, or exfoliative skin conditions (e.g., atopic
dermatitis, burns, impetigo, varicella zoster, severe acne, or other open
rashes or wounds)
- Pregnant or nursing women
- Children under 5 years old
- Immunodeficient or immunosuppressed persons (by disease or therapy),
including those with HIV infection
Expected Enrollment A total of 28 (14 per treatment arm) patients will be accrued for this study within 18 months. Outline This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
- Vaccinia-CEA-TRICOM: Beginning 2-3 weeks after surgery and before initiation of standard adjuvant chemotherapy, all patients receive vaccinia-CEA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4 of week 1.
- Fowlpox-CEA-TRICOM: Patients are treated on 1 of the following schedules:
- Arm I: During chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of weeks 2, 5, 8, 11, 14, 17, 20, and 23. After chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
- Arm II: Prior to chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of week 2. After chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
- Chemotherapy: Patients receive doxorubicin IV over 5-7 minutes and cyclophosphamide IV over 30 minutes on day 1 of weeks 3, 6, 9, and 12. Patients then receive paclitaxel IV over 3 hours on day 1 of weeks 15, 18, 21, and 24. Treatment continues in the absence of disease progression (after at least 1 course of chemotherapy) or unacceptable toxicity.
- Radiotherapy: Patients undergo radiotherapy during weeks 26-32 in the absence of disease progression.
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.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | Philip Arlen, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) |
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | 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 | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2002-09-16 | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00052351 | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2002-09-27 | ![](https://webarchive.library.unt.edu/eot2008/20081015132122im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2003-05-06 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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