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:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT00228358
Eligibility Criteria:
Inclusion Criteria:
* Patients with progressive HER2/neu overexpressing metastatic breast, ovarian, or non-small cell lung cancer not considered curable by conventional therapies, including trastuzumab
* Extra-skeletal disease that can be accurately measured \>= 10 mm by standard imaging techniques that can include but not limited to computed tomography (CT), positron emission tomography (PET), magnetic resonance imaging (MRI)
* Skeletal or bone-only disease which is measurable by Fludeoxyglucose F 18 (FDG) PET imaging will also be allowed
* Patients with ovarian cancer may have measurable disease; however, their only indication of progression may be an abnormal CA-125
* Patients must have documented HER-2/neu overexpression in their tumor (either primary or metastasis) as was required per the eligibility criteria of their original vaccination protocol
* Patients must have received HER2-specific vaccinations while enrolled on a HER2 vaccine protocol approved at the University of Washington Human Subjects Division
* Patients must have undergone leukapheresis after vaccination through a protocol approved at the University of Washington Human Subjects Division and have product stored for clinical use
* Subjects must have a Performance Status Score (Zubrod/Eastern Cooperative Oncology Group \[ECOG\] Scale) = 0 or 1
* Patients can be currently receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy
* Patients on trastuzumab and/or lapatinib must have adequate cardiac function as demonstrated by multi gated acquisition (MUGA) scan or echocardiogram (ECHO) within 90 days of eligibility determination
* Patients must be off all immunosuppressive treatments, and/or systemic steroid therapy, for at least 14 days prior to initiation of study treatment
* Patients must be off chemotherapy and trastuzumab for at least 1 week prior to the first infusion of T cells
* Men and women of reproductive ability must agree to contraceptive use during the study and for one month after the final T cell infusion
* Patients with a history of brain metastases must have a stable head imaging study within 30 days of enrollment
* White blood cells (WBC) \>= 3000/mm\^3
* Absolute neutrophil count (ANC) \>= 1000/mm\^3
* Hemoglobin (Hgb) \>= 10 mg/dl
* Platelets \>= 75,000mm\^3
* Serum creatinine =\< 2.0 mg/dl or creatinine clearance \> 60 ml/min
* Total bilirubin =\< 2.5 mg/dl
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =\< 3 times ULN
Exclusion Criteria:
* Concurrent enrollment in other treatment studies
* Patients with any of the following cardiac conditions:
* Symptomatic restrictive cardiomyopathy
* Unstable angina within the last 4 months prior to enrollment
* New York Heart Association functional class III-IV heart failure on active treatment
* Patients with any clinically significant autoimmune disease uncontrolled with treatment
* Pregnant or breast-feeding women
* Known history of hypersensitivity to diphtheria toxin or interleukin (IL)-2 (only for subjects enrolled in Group B)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00228358
Study Brief:
Protocol Section:
NCT00228358