Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01820754 : Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC)
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

Patients are eligible to be in the study if they meet all of the following criteria:

- Histologically or cytologically documented non-small cell lung cancer (NSCLC)

- Clinical stage IB (?4cm per CT), Stage IIA/IIB, or Stage III (N0-2) amenable to
surgical resection

- Patients must be deemed a surgical candidate

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- No prior chemotherapy for current diagnosis of lung cancer

- Age is ? (greater than or equal to) 18 years

- No active invasive malignancy in the past 2 years other than non-melanoma skin
cancer. Cancers that are in-situ are not considered invasive

- Signed written informed consent including Health Insurance Portability and
Accountability Act (HIPAA) authorization according to institutional guidelines

- Adequate Organ Function:

- Absolute neutrophil count (ANC) or absolute granulocyte count (AGC) ?1500 per
microliter (uL)

- Platelets ? 100,000 per uL

- Total bilirubin ?(less than or equal to)1.5 milligram per deciliter (mg/dL)

- Creatinine clearance ? 45 milliliter per minute (mL / min); (Creatinine <
2mg / dL to receive cisplatin)

- Serum glutamic-oxaloacetic transaminase / Serum glutamic pyruvic transaminase
(SGOT/SGPT) ? 2.5x institutional upper limit normal (ULN)

- Females of child-bearing potential (not surgically sterilized and between menarche
and 1 year post menopause) must test negative for pregnancy within 48 hours prior
to any initial study procedure based on a serum pregnancy test. Both sexually active
males and females of reproductive potential must agree to use a reliable method of
birth control, as determined by the patient and their health care team, during the
study and for 3 months following the last dose of study drug. If subject uses
appropriate contraceptive methods (the use of two forms at the same time) from the
time of the initial serum pregnancy test, then the subsequent pregnancy test can be
done within 72 hours of receiving study drug administration. If appropriate
contraceptive measures are not begun immediately with the first serum pregnancy test,
then subsequent serum pregnancy tests must be done within 48 hours prior to the study
drug administration

- Patients must agree to research blood sampling to participate in study

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

- Have had treatment within the last 30 days with a drug that has not received
regulatory (Food and Drug Administration (FDA)) approval for any indication at the
time of study entry

- Concurrent administration of any other anti-tumor therapy

- Inability to comply with protocol or study procedures

- Active infection requiring intravenous (IV) antibiotics, antifungal or antiviral
agents, that in the opinion of the investigator would compromise the patient's
ability to tolerate therapy

- Major surgery (other than definitive lung cancer surgery) within two weeks of study
or other serious concomitant systemic disorders that, in the opinion of the
investigator, would compromise the safety of the patient or compromise the patient's
ability to complete the study

- Myocardial infarction (MI) having occurred less than 6 months before inclusion, any
known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or
cardiac failure not controlled by medications

- Contraindication to corticosteroids

- Unwillingness to stop taking herbal supplements while on study

- Female patients who are pregnant or breast-feeding

- Autoimmune disease. Patients with a history of inflammatory bowel disease, including
ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients
with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic
progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune
vasculitis [eg, Wegener's Granulomatosis]); motor neuropathy considered of autoimmune
origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis)

- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up
to 1 month before or after any dose of ipilimumab)

- A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4
inhibitor or agonist

- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (e.g., infectious) illness
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01820754      |      Link to official Clinicaltrials.gov listing
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