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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

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.

PROJECTED ACCRUAL: A total of 28 (14 per treatment arm) patients will be accrued for this
study within 18 months.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Philip M. Arlen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000258196

NCT ID:

NCT00052351

Start Date:

September 2002

Completion Date:

October 2007

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Center for Cancer ResearchBethesda, Maryland  20892