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An Open Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer (NSCLC)


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Lung Neoplasm

Thank you

Trial Information

An Open Label, Multi-center Safety and Tolerance Study of EP2101 Peptide Vaccine in Patients With Stage IIb or IIIa Non-Small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

EP2101-101

NCT ID:

NCT00054899

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasm
  • vaccine
  • lung
  • cancer
  • Carcinoma, Large Cell
  • Non-Small-Cell Lung Carcinoma
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of WashingtonSeattle, Washington  98195
Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
Duke University Medical CenterDurham, North Carolina  27710
Cancer Centers of FloridaOrlando, Florida  32806
University of California, Los AngelesLos Angeles, California  
New York Oncology HematologyAlbany, New York  12208