Status:
COMPLETED
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
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2-positive Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 gr...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the feasibility of expanding HER2 specific T cells ex vivo for infusion into subjects who have advanced HER2 overexpressing cancer. II. To assess the toxicity associ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00228358
Start Date
June 1 2003
Last Update
November 11 2014
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109