Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT00005956
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00005956
Study Brief:
Protocol Section:
NCT00005956