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A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Resectable Pancreatic Adenocarcinoma

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Trial Information

A Phase I Clinical Trial of GM-CSF Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma


Inclusion Criteria:



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

Exclusion Criteria:

1. Patients who have undergone previous treatment with a biological response modifier
(interferons, interleukins) or prior immunotherapy within four (4) weeks of study
enrollment.

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
Investigators.

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
form.

11. Clinically significant (symptomatic) third space fluid collection (i.e.: ascites,
pleural effusion).

12. Patients with a diagnosis of an autoimmune state, or any psychiatric illness that in
the opinion of the Investigators would compromise treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the toxicity, immune system status, quality of life, and potential clinical benefit of systemic GM-CSF administration in patients with pancreatic adenocarcinoma.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Edward L Nelson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 02-69

NCT ID:

NCT00600002

Start Date:

June 2004

Completion Date:

Related Keywords:

  • Resectable Pancreatic Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868