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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00600002
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histological proven adenocarcinoma of the pancreas with potentially resectable disease based upon clinical staging.
* Expected survival must be greater than three (3) months.
* A Karnofsky Performance Status (KPS) must be 70 or greater.
* Patients must be \>18 years of age. Because Leukine® is a "Pregnancy Category C" drug, female patients must be not be lactating and must be surgically sterile (via hysterectomy or bilateral tubal ligation), postmenopausal, or using acceptable methods of contraception if they are of child bearing potential. Female patients of childbearing potential must also have a negative serum pregnancy test.
* Patients must be able to understand and sign an informed consent form, which must comply with U.S. regulations (U.S. 21 Code of Federal Regulations (CFR) 50) and International Conference on Harmonisation (ICH) guidelines. Availability of alternative curative treatment must be fully explained to the patient and documented in the informed consent form.
* Eligible patients must meet the following laboratory parameters:
* White blood cell (WBC) \>3,000/mm3
* Platelets \>100,000/mm3
* Hct \>33% or Hgb \>10.5 gm/dL
* Prothrombin time (PT) within 3 seconds of control
* Serum creatinine \<1.5 mg/dL
* Serum calcium \<11.0 mg/dL
* Serum Amylase \< 2 times the upper limit of normal
* Negative HIV-Ag and HIV-Ab
Exclusion Criteria:
* Patients who have undergone previous treatment with a biological response modifier (interferons, interleukins) or prior immunotherapy within four (4) weeks of study enrollment.
* Patients currently requiring corticosteroids, under immune suppression for any reason including an organ allograft.
* Patients with known contraindications to analgesia or endoscopy.
* Patients with unstable cardiovascular disease (Class IV cardiovascular disease according to the New York Heart Association's functional criteria).
* Patients with any acute or chronic illness as judged clinically significant by the Investigators.
* Patients who have received prior chemotherapy or radiation therapy to the thorax within four (4) weeks of enrollment.
* Prior surgery within 30 days of execution of the informed consent form.
* Persistent fever greater than 39 degrees Celsius unless clinical assessment attributes the etiology to be tumor.
* Primary malignancy (present or remote) of sites other than the pancreas, except for the basal cell epithelioma of the skin.
* Use of investigational drugs within 30 days of execution of the informed consent form.
* Clinically significant (symptomatic) third space fluid collection (i.e.: ascites, pleural effusion).
* Patients with a diagnosis of an autoimmune state, or any psychiatric illness that in the opinion of the Investigators would compromise treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00600002
Study Brief:
Protocol Section:
NCT00600002