Lung Cancer Clinical Trial
Official title:
A Phase I Study of Anti-CD3 x Cetuximab-Armed Activated T Cells, Low Dose IL-2, and GM-CSF for EGFR-Positive, Advanced Non-Small Cell Lung Cancer
Verified date | March 2015 |
Source | Roger Williams Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with
antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate
the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may
increase the number of immune cells found in bone marrow or peripheral blood. Giving
laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more
tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated
autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients
with recurrent, refractory, or metastatic non-small cell lung cancer.
FUNDING SOURCE--FDA OOPD
Status | Terminated |
Enrollment | 5 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) - Recurrent, refractory, or metastatic disease after = 1 prior first-line regimen (chemotherapy or radiotherapy) - Documented EGFR-positive disease (any expression level) by immunohistochemistry (IHC) (may be based on archival sample) - Measurable or evaluable disease by radiograph, CT scan, MRI, and/or physical exam - Appropriate slides of the primary lesion must be available for review of IHC staining assessment by a central pathology team - No clinical evidence of active brain metastases - Patients with brain metastases are eligible provide they have received definitive radiotherapy or chemotherapy and/or have undergone surgical resection for brain metastases - No prior hematological malignancy PATIENT CHARACTERISTICS: - Karnofsky performance status (PS) 60-100% OR ECOG PS 0-2 - Life expectancy = 3 months - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Granulocytes = 1,000/mm^3 - Platelet count = 50,000/mm^3 - Hemoglobin = 8 g/dL - BUN = 2.0 times normal - Serum creatinine = 2.0 mg/dL - Bilirubin = 1.5 times normal - SGOT = 1.5 times normal (with or without liver metastases) - Hepatitis B surface antigen and HIV negative - LVEF = 45 % at rest (by MUGA) - No evidence of depressed left ventricular function - FEV_1, DLCO, and FVC = 50% of the predicted value - No other malignancy, except for the following: - History of curatively treated in situ squamous cell carcinoma or basal cell carcinoma of the skin - History of other curatively treated malignancy (except those with a hematologic origin) for which the patient has remained in complete remission > 5 years after completing therapy (as documented by history, physical exams, tumor markers, and radiology scanning) - No serious medical or psychiatric illness that would preclude giving informed consent or receiving intensive treatment - No recent myocardial infarction (within the past year) - No current angina/coronary symptoms requiring medications - No clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA results) - No systolic blood pressure (BP) = 130 mm Hg or diastolic BP = 80 mm Hg - Patients with elevated BP must have it controlled by anti-hypertensive medications for at least 7 days prior to the first infusion PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 4 weeks since prior chemotherapy or radiotherapy - At least 4 weeks since prior cetuximab or small molecule EGFR-inhibitors including, but not limited to, gefitinib or erlotinib hydrochloride - No concurrent radiotherapy - No concurrent steroids except for treatment of adrenal failure, septic shock, or pulmonary toxicity or hormones for non-disease-related conditions (e.g., insulin for diabetes) |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roger Williams Medical Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Roger Williams Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | 4 weeks | Yes | |
Primary | Maximum tolerated dose of EGFRBi-armed autologous activated T-cells | 4 weeks | Yes | |
Primary | Determination of immunologic changes by evaluation of cytokine profiles obtained before and after stimulation with OKT3 in vitro | 4 weeks | No | |
Secondary | Overall survival | 2 years | No | |
Secondary | Progression-free survival | 2 years | No | |
Secondary | Evaluation of tumor markers and human anti-mouse antibody responses as assessed by carcinoembryonic antigen (CEA) levels in serum samples and development of IgG and IgM anti-mouse antibody responses to the Bi-antibodies | 4 weeks | No | |
Secondary | Determination of immunologic changes by evaluation of peripheral blood lymphocytes | 4 weeks | No | |
Secondary | Determination of immunologic changes by evaluation of cytotoxic T-lymphocytes as measured by interferon gamma ELISPOTS directed at autologous tumor or lung cancer cell lines | 4 weeks | Yes | |
Secondary | Determination of immunologic changes by evaluation of phenotypes of peripheral blood mononuclear cells before and after immunotherapy | 4 weeks | No |
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