Breast Cancer Clinical Trial

Biological Therapy in Treating Patients With Advanced Cancer

Summary

RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.

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Full Description

OBJECTIVES:

Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells.
Assess time to recurrence in these patients.

OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year or until disease progression.

PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed advanced malignancy that expresses HER2/neu

Stage IIA breast cancer with more than 6 positive lymph nodes
Stage IIB, IIIA, or IIIB breast cancer
Stage III ovarian cancer
Lymph node positive gastric cancer
Metastatic tumor
No measurable or evaluable disease after standard treatment
No previously irradiated or newly diagnosed CNS metastases

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Age:

18 and over

Menopausal status:

Not specified

Performance status:

Karnofsky 80-100%

Life expectancy:

Greater than 6 months

Hematopoietic:

WBC at least 3,000/mm^3
Hemoglobin at least 9 mg/dL
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin less than 2.0 mg/dL
No hepatic disease, including viral hepatitis

Renal:

Creatinine less than 2.5 mg/dL

Cardiovascular:

No New York Heart Association class III or IV heart disease

Pulmonary:

No asthma or chronic obstructive pulmonary disease

Immunologic:

Must have positive intradermal delayed hypersensitivity test for at least 1 of the following:

Candida
Mumps
Tetanus
Trichophyton
Histoplasmin

No prior autoimmune disease including, but not limited to, the following:

Inflammatory bowel disease
Systemic lupus erythematosus
Ankylosing spondylitis
Scleroderma
Multiple sclerosis

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
Hepatitis B surface antigen and hepatitis C antibody negative
No other concurrent serious chronic or acute illness or infection (including urinary tract infection)
No known shellfish or iodine allergy
No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer
No medical or psychological condition that may preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No other concurrent immunotherapy

Chemotherapy:

At least 4 weeks since prior chemotherapy and recovered
No concurrent chemotherapy

Endocrine therapy:

Concurrent hormonal therapy allowed (tamoxifen, raloxifene, toremifene, and all aromatase inhibitors)
At least 4 weeks since prior steroid or immunosuppressive therapy (e.g, azathioprine or cyclosporine)

Radiotherapy:

Prior radiotherapy allowed except to cranium
At least 4 weeks since prior radiotherapy and recovered
At least 12 weeks since prior strontium chloride Sr 89
No concurrent radiotherapy

Surgery:

At least 4 weeks since prior surgery and recovered

Other:

Concurrent bisphosphonates allowed
No prior hepatitis B immunization

Study is for people with:

Breast Cancer

Estimated Enrollment:

3

Study ID:

NCT00005956

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

3

Study ID:

NCT00005956

Recruitment Status:

Completed

Sponsor:


Duke University

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