Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600002
• Other study ID #: UCI 02-69
• Secondary ID: 2003-2972
• Status: Completed
• Phase: Phase 1
• Start date: June 2004
• Est. completion date: April 2018

Study information

• Verified date: June 2018
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The application of immunotherapeutic strategies that target the most potent antigen presenting cell, the dendritic cell (DC), are likely to substantially increase the magnitude of the anti-tumor immune response. Although there are issues of activation state and antigen load, mechanisms to increase the number of DCs available to the immune system are among the first steps in development of affective DC based immunotherapeutic strategies. The Central Hypothesis of our study is: Administration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) to patients with pancreatic adenocarcinoma will result in enhance recruitment of DCs to the sentinel lymph node, into the peripheral blood, and/or tumor site. We propose performing a phase I, dose escalation, clinical trial of systemic and intra-tumoral GM-CSF administration for the treatment of pancreatic adenocarcinoma. This trial will be designed to assess toxicity and immunologic effects, principally dendritic cell recruitment. Patients with resectable pancreatic adenocarcinoma by clinical staging criteria will be eligible for enrollment.

The trial we propose is a phase I clinical trial of the addition of GM-CSF as a biological adjuvant to standard care for patients with potentially resectable pancreatic adenocarcinoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Neoplasms
• Resectable Pancreatic Adenocarcinoma

Intervention

Biological:
• GM-CSF
Cohort 1: 50 ug/m2 given Intravenous. Cohort 2: 150 ug/m2 given Intravenous. Cohort 3: 250 ug/m2 given Intravenous. Cohort 4: 0 ug/m2 and vehicle (normal saline) given Intra-tumoral. Cohort 5: 50 ug/m2 given Intra-tumoral. Cohort 6: 150 ug/m2 given Intra-tumoral. Cohort 7: 250 ug/m2 given Intra-tumoral.

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Edward Nelson

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate toxicity, dendritic cell recruitment, and immune parameters		2 years
Secondary	Evaluate patient survival		2 years
Secondary	Evaluate progression free survival		2 years
Secondary	Evaluate time to treatment failure		2 years
Secondary	Evaluate quality of life		2 years
Secondary	Evaluate biochemical markers		2 years