Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine

Completed · Phase 1

Conditions studied: HER2-positive Breast Cancer, Recurrent Breast Cancer, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Stage IV Breast Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor

In brief

This phase I trial studies the safety and the ability to expand laboratory-treated T cells when given together with cyclophosphamide or denileukin diftitox in treating patients with human epidermal growth factor receptor (HER)-2/neu overexpressing metastatic breast cancer, ovarian cancer, or non-small cell lung cancer previously treated with HER-2/neu vaccine. Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as denileukin diftitox, may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor cells

Key facts

Study ID: NCT00228358
Run by: University of Washington
People needed: 8
Starts: 2003-06-01
Last updated by the study team: 2014-11-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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