Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer, male breast cancer, unspecified adult solid tumor, protocol specific
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed breast cancer meeting 1 of the following criteria: Recurrent and/or metastatic lesions that are HER2/neu-positive or negative Recurrent or progressive cancer of the lung, ovary, pancreas, prostate, bladder, or other primary site associated with HER2/neu-positive tumor by histochemistry Bone-only metastatic breast cancer, cytologically confirmed malignant effusions, histologically confirmed marrow involvement, or other evaluable (but non-measurable) metastatic disease allowed Failed prior first-line chemotherapy (e.g., anthracycline- or taxane-based therapy) with or without adjuvant chemotherapy or hormonal therapy No curative or reliably effective palliative surgery, radiotherapy, or medical therapy available Stable brain metastases allowed provided the following criteria are met*: Previously treated No concurrent requirement for corticosteroids No radiological or clinical deterioration within the past 6 weeks NOTE: *Patients who had recent treatment with gamma knife or intensity-modulated radiotherapy for brain metastases are eligible provided there has been recovery from known or anticipated toxic effects Patients with no HLA-A2 allele are eligible Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Female or male Menopausal status Not specified Performance status ECOG 0-2 Life expectancy At least 4 months Hematopoietic Absolute granulocyte count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 2 mg/dL Alkaline phosphatase ≤ 5 times upper limit of normal (ULN) ALT and AST ≤ 2 times ULN Renal BUN ≤ 30 mg/dL Creatinine ≤ 2 mg/dL ≤ 1 g protein on 24-hour urine collection OR ≤ 1+ proteinuria on urinalysis Cardiovascular Hypertension controlled by agents (except beta-blockers) allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No history of anaphylactic reaction to any known or unknown antigen No history of clinical hypersensitivity to sargramostim (GM-CSF), interferon, yeast, beef, or to any components used in preparation of study vaccine No clinical or laboratory features indicative of AIDS No rheumatological, psychiatric, or other clinically progressive major medical problems requiring treatment No other malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy More than 3 weeks since prior biological therapy, including trastuzumab (Herceptin^®) More than 3 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy See Disease Characteristics More than 3 weeks since prior chemotherapy (8 weeks for nitrosoureas or mitomycin) No concurrent chemotherapy Endocrine therapy See Disease Characteristics More than 3 weeks since prior hormonal therapy No concurrent hormonal therapy No concurrent systemic steroids Concurrent inhalation steroids for respiratory hypersensitivity (e.g., triamcinolone nasal or pulmonary inhalers) allowed Radiotherapy See Disease Characteristics More than 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery More than 3 weeks since prior major surgery with general anesthesia No concurrent major surgery Other Recovered from prior therapy Patients receiving pamidronate, bisphosphonates, or other supportive measures must continue therapy during study participation No concurrent anticoagulants No concurrent beta-blockers for control of mild hypertension or other indications
Sites / Locations
- Glendale Memorial Hospital Comprehensive Cancer Center
- Hollywood Presbyterian Medical Center