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NCT00600002 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Pancreatic Cancer and Resectable Pancreatic Adenocarcinoma, sponsored by Edward Nelson.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT00600002 is a Phase 1 study of Pancreatic Cancer and Resectable Pancreatic Adenocarcinoma that has completed, run by Edward Nelson. The registered enrollment target is 30 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00600002, a Phase 1 study of Pancreatic Cancer and Resectable Pancreatic Adenocarcinoma, has completed, sponsored by Edward Nelson.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • BIOLOGICAL GM-CSF

Study Locations (1)

California

  • Chao Family Comprehensive Cancer Center - Orange

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2004-06
Est. Completion 2018-04
Phase Phase 1

Sponsor

Edward Nelson

1 total trials

What the Registry Record Tells You About NCT00600002

The ClinicalTrials.gov registry entry for NCT00600002 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (92% lower). The listed sponsor is Edward Nelson, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which GM-CSF is the first listed.

NCT00600002 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00600002 about?

NCT00600002 is a clinical study titled "Administration as a Biological Adjuvant in Clinically-Staged, Resectable Pancreatic Adenocarcinoma". 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 t...

What is the current status of trial NCT00600002?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2004-06. Estimated completion is 2018-04.

What conditions does trial NCT00600002 study?

This clinical trial studies the following conditions: Pancreatic Cancer, Resectable Pancreatic Adenocarcinoma.

What interventions are being tested in trial NCT00600002?

The interventions under investigation include: GM-CSF (BIOLOGICAL).

Who is sponsoring clinical trial NCT00600002?

This trial is sponsored by Edward Nelson, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00600002 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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