A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma
1. Patients must have histological proven adenocarcinoma of the pancreas with
potentially resectable disease based upon clinical staging.
2. Expected survival must be greater than three (3) months.
3. A Karnofsky Performance Status (KPS) must be 70 or greater (Appendix I).
4. 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.
5. Patients must be able to understand and sign an informed consent form, which must
comply with U.S. regulations (U.S. 21 CFR 50) and ICH guidelines. Availability of
alternative curative treatment must be fully explained to the patient and documented
in the informed consent form.
6. Eligible patients must meet the following laboratory parameters:
- 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
1. Patients who have undergone previous treatment with a biological response modifier
(interferons, interleukins) or prior immunotherapy within four (4) weeks of study
2. Patients currently requiring corticosteroids, under immune suppression for any reason
including an organ allograft.
3. Patients with known contraindications to analgesia or endoscopy.
4. Patients with unstable cardiovascular disease (Class IV cardiovascular disease
according to the New York Heart Association's functional criteria, Appendix II).
5. Patients with any acute or chronic illness as judged clinically significant by the
6. Patients who have received prior chemotherapy or radiation therapy to the thorax
within four (4) weeks of enrollment.
7. Prior surgery within 30 days of execution of the informed consent form.
8. Persistent fever greater than 39C unless clinical assessment attributes the etiology
to be tumor.
9. Primary malignancy (present or remote) of sites other than the pancreas, except for
the basal cell epithelioma of the skin.
10. Use of investigational drugs within 30 days of execution of the informed consent
11. Clinically significant (symptomatic) third space fluid collection (i.e.: ascites,
12. Patients with a diagnosis of an autoimmune state, or any psychiatric illness that in
the opinion of the Investigators would compromise treatment.