NCT00052351

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Sep 2002

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 19, 2013

Status Verified

May 1, 2003

First QC Date

January 24, 2003

Last Update Submit

June 17, 2013

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancer

Interventions

recombinant fowlpox-CEA(6D)/TRICOM vaccineBIOLOGICAL
recombinant vaccinia-CEA(6D)-TRICOM vaccineBIOLOGICAL
sargramostimBIOLOGICAL
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
paclitaxelDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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 PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status: * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sargramostimCyclophosphamideDoxorubicinPaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenesTherapeutics

Study Officials

  • Philip M. Arlen, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 24, 2003

First Posted

January 27, 2003

Study Start

September 1, 2002

Study Completion

October 1, 2007

Last Updated

June 19, 2013

Record last verified: 2003-05

Locations

US(2)