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Sponsored by: |
Epimmune |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00104780 |
RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Lung Cancer |
Biological: EP-2101 Biological: incomplete Freund's adjuvant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II, Open Label, Multi-Center Study of EP2101 Therapeutic Vaccine in Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer (NSCLC) |
Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:
HLA-A2-positive disease
No CNS signs or symptoms of brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
No history of any of the following active conditions:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Florida | |
Cancer Centers of Florida - Ocoee | |
Ocoee, Florida, United States, 34761 | |
United States, New York | |
New York Oncology Hematology, P. C. at Albany Regional Cancer Care | |
Albany, New York, United States, 12208 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Dayton Oncology & Hematology, P.A. - Kettering | |
Kettering, Ohio, United States, 45409 | |
United States, South Carolina | |
Cancer Centers of the Carolinas - Eastside | |
Greenville, South Carolina, United States, 29615 | |
United States, Tennessee | |
Sarah Cannon Cancer Center at Centennial Medical Center | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Mary Crowley Medical Research Center at Sammons Cancer Center | |
Dallas, Texas, United States, 75246 | |
Tyler Cancer Center | |
Tyler, Texas, United States, 75702 | |
United States, Washington | |
Cancer Care Northwest - North | |
Spokane, Washington, United States, 99218 |
Study Chair: | Scott Plasman | Epimmune |
Study ID Numbers: | CDR0000415721, EPIMMUNE-EP2101-201, MCMRC-0461 |
Study First Received: | March 3, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00104780 History of Changes |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer |
Thoracic Neoplasms Immunologic Factors Respiratory Tract Diseases Lung Neoplasms Lung Diseases Adjuvants, Immunologic |
Non-small Cell Lung Cancer Freund's Adjuvant Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Freund's Adjuvant Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |