Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Metronidazole; Paclitaxel; Sargramostim; Vaccines

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