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 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT00028535
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed HER2/neu-overexpressing (2+ or 3+) malignancy by any standardized assay (fluorescence in-situ hybridization allowed)
* Measurable or evaluable disease
* Failed standard curative therapy
* No brain or CNS metastasis
* Hormone receptor status:
* Not specified
* Male or female
* Performance status - Karnofsky 70-100%
* At least 6 months
* Absolute neutrophil count at least 1,500/mm\^3
* Hemoglobin at least 8 g/dL (transfusion or epoetin alfa allowed)
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 3.0 times ULN
* Hepatitis B surface antigen negative
* Creatinine no greater than 1.5 times ULN
* Calcium no greater than 11 mg/dL (calcium-lowering agents allowed)
* No active or unstable cardiovascular disease
* No cardiac disease requiring drug or device intervention
* No coronary artery disease
* No congestive heart failure
* Cardiac ejection fraction normal by echocardiogram or MUGA scan
* No significant peripheral neuropathy
* No significant CNS disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No serious concurrent infection requiring IV antibiotic therapy
* No clinically significant autoimmune disease (e.g., rheumatoid arthritis)
* No clinically significant gastrointestinal bleeding
* No uncontrolled peptic ulcer disease
* No inflammatory bowel disease
* No other major illness that would preclude study participation
* No other concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix
* No prior interleukin-12
* No prior trastuzumab (Herceptin®)
* At least 3 weeks since prior chemotherapy
* At least 3 weeks since prior hormonal therapy
* No concurrent systemic corticosteroids
* At least 3 weeks since prior radiotherapy
* At least 3 weeks since prior surgery
* At least 3 weeks since prior investigational drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00028535
Study Brief:
Protocol Section:
NCT00028535