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

Primary Purpose

Resectable Pancreatic Adenocarcinoma, Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GM-CSF

About this trial

This is an interventional treatment trial for Resectable Pancreatic Adenocarcinoma focused on measuring GM-CSF, Leukine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chao Family Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GM-CSF

Arm Description

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.

Outcomes

Primary Outcome Measures

Evaluate toxicity, dendritic cell recruitment, and immune parameters

Secondary Outcome Measures

Evaluate patient survival

Evaluate progression free survival

Evaluate time to treatment failure

Evaluate quality of life

Evaluate biochemical markers

Full Information

NCT ID

NCT00600002

First Posted

January 17, 2008

Last Updated

June 7, 2018

Sponsor

Edward Nelson

1. Study Identification

Unique Protocol Identification Number

NCT00600002

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Edward Nelson

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resectable Pancreatic Adenocarcinoma, Pancreatic Cancer

Keywords

GM-CSF, Leukine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GM-CSF

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

GM-CSF

Intervention Description

Primary Outcome Measure Information:

Title

Evaluate toxicity, dendritic cell recruitment, and immune parameters

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Evaluate patient survival

Time Frame

2 years

Title

Evaluate progression free survival

Time Frame

2 years

Title

Evaluate time to treatment failure

Time Frame

2 years

Title

Evaluate quality of life

Time Frame

2 years

Title

Evaluate biochemical markers

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward L Nelson, M.D.

Organizational Affiliation

Chao Family Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chao Family Comprehensive Cancer Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

12. IPD Sharing Statement

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

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