Biological Therapy in Treating Patients With Advanced Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study of Active Immunotherapy With HER2/Neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients With No Evidence of Disease After Standard Treatment for HER2/Neu Expressing Malignancies

Conditions
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Breast Cancer, Gastric Cancer, Ovarian Cancer

Intervention / Treatment
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* Biological: HER-2/neu intracellular domain protein
* Biological: therapeutic autologous dendritic cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HER-2/neu intracellular domain protein|nan|
|Biological: therapeutic autologous dendritic cells|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | safety | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV ovarian epithelial cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, stage II gastric cancer, stage III gastric cancer, stage IV gastric cancer, stage IIIB breast cancer, stage III ovarian epithelial cancer