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An Open Label Study of a Peptide Vaccine in Patients with Stage IIb or IIIa Non-Small Cell Lung Cancer



An Open Label Study of a Peptide Vaccine in Patients with Stage IIb or IIIa Non-Small Cell Lung Cancer

For Condition: Carcinoma, Non-Small-Cell Lung,Lung Neoplasm
Status: Completed
Sponsor(s): Epimmune ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 18

Location and Contact Information:

Mary Crowley Medical Research Center
Dallas,  Texas,  75246
United States
 

New York Oncology Hematology
Albany,  New York,  12208
United States
 

University of Washington
Seattle,  Washington,  91895
United States
 

Duke University Medical Center
Durham,  North Carolina,  27710
United States
 

Tyler Cancer Center
Tyler,  Texas,  75702
United States
 

Cancer Centers of Florida
Orlando,  Florida,  32806
United States
 

Cancer Care Northwest
Spokane,  Washington,  99218
United States
 

University of California, Los Angeles
Los Angeles,  California,  90095
United States
 


Additional Information:
Study ID Numbers:
  EP2101-101; 
Study Start Date: January 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054899

Other Lung Neoplasm Studies:
1. Study of 111In-DAC as an Medical Imaging Agent for Lung Cancer and Brain Cancer Consistent with Metastatic Lung Cancer

2. OSI-774 (Tarceva) in Treating Patients with Stage III or Stage IV Non-Small Cell Lung Cancer

3. Temozolomide for Treatment of Brain Metastases from Non-Small Cell Lung Cancer

4. A Phase 2 Trial of Antisense Nucleotide to PKC-alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients with Advanced, Previously Untreated Non-Small Cell Lung Cancer.

5. Phase II Neoadjuvant Trial of a Continuous Infusion of Paclitaxel Plus Cisplatin Followed by Chest Radiotherapy for Patients with Stage III Non-Small Cell Lung Cancer

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