NCT00054899

Brief Summary

EP2101 is a new cancer vaccine containing 10 different peptide antigens. The vaccine is designed to activate the immune system to develop a response against tumor cells in order to delay or prevent the recurrence of cancer. This study will test the safety and measure the level of immune stimulating capability of EP2101 in patients with Non-Small Cell Lung Cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 12, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2003

Completed
Last Updated

March 24, 2010

Status Verified

April 1, 2004

First QC Date

February 12, 2003

Last Update Submit

March 23, 2010

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasm

Keywords

vaccinelungcancerCarcinoma, Large CellNon-Small-Cell Lung Carcinoma

Interventions

EP2101BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of Non-Small Cell Lung Cancer, stage IIb or IIIa
  • At least four weeks following prior standard treatment, with no evidence of disease
  • Must use adequate birth control

You may not qualify if:

  • Prior cancer vaccine therapy or concurrent participation in any other investigational study
  • A history of HIV, Hepatitis B or C, or any other acute medical condition which may compromise patient safety or the activity of the study vaccine treatment
  • A history of adverse reactions following administration of any vaccines, or a history of hypersensitivity to any components of the study vaccine
  • Women who are pregnant, intend to become pregnant, or who are breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Cancer Centers of Florida

Orlando, Florida, 32806, United States

Location

New York Oncology Hematology

Albany, New York, 12208, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

University of Washington

Seattle, Washington, 91895, United States

Location

Cancer Care Northwest

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasmsCarcinoma, Large Cell

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 12, 2003

First Posted

February 14, 2003

Study Start

January 1, 2003

Last Updated

March 24, 2010

Record last verified: 2004-04

Locations

US(8)