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Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: March 3, 2005
Last updated: November 5, 2013
Last verified: March 2006

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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Comparison of overall survival with historical controls
  • Safety

Secondary Outcome Measures:
  • Progression-free survival
  • Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes

Study Start Date: December 2004
Detailed Description:



  • Compare the overall survival of patients with HLA-A2-positive, stage IIIB or IV or recurrent non-small cell lung cancer (NSCLC) treated with vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 with that of historical controls and patients with HLA-A2-negative, stage IIIB or IV or recurrent NSCLC who undergo observation only.
  • Determine the safety of this vaccine in these patients.


  • Determine progression-free survival of patients treated with this vaccine.
  • Determine the frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes in patients treated with this vaccine.

OUTLINE: This is an open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HLA-A2 status.

  • Group I (HLA-A2 positive): Patients receive vaccine therapy comprising EP-2101 emulsified in montanide ISA-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15.
  • Group II (HLA-A2 negative): Patients undergo observation in weeks 9 and 18. After completion of study treatment, patients in group I are followed at 3 weeks. All patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 1 year.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria:

    • Stage IIIB disease
    • Stage IV disease
    • Recurrent disease
  • HLA-A2-positive disease

    • HLA-A2 negative patients are eligible to enroll in group II (observation) only
  • Measurable disease
  • Estimated tumor volume ≤ 125 cc
  • No CNS signs or symptoms of brain metastases

    • Brain metastases that are clinically stable for ≥ 2 months AND do not require anticonvulsants or systemic steroids are allowed



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks


  • Hemoglobin ≥ 10 g/dL
  • Platelet count > 100,000/mm^3
  • WBC > 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Absolute lymphocyte count > 500/mm^3


  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for patients with liver involvement by tumor)
  • Bilirubin ≤ 2.0 mg/dL (3.0 mg/dL for patients with liver involvement by tumor)
  • Albumin ≥ 2.5 g/dL
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No history of hepatitis B or C positivity


  • Creatinine ≤ 2 times ULN


  • No history of any of the following active conditions:

    • Systemic lupus erythematosus
    • Scleroderma
    • Connective tissue disease
    • Sjögren's syndrome
    • Multiple sclerosis
    • Rheumatoid arthritis
    • Inflammatory bowel disease
  • No history of HIV positivity
  • No history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 weeks after completion of study treatment
  • No other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix
  • No other acute medical condition that would preclude study treatment
  • No mental or psychiatric condition that would preclude study compliance


Biologic therapy

  • More than 1 month since prior interferon therapy
  • More than 1 month since prior interleukin therapy
  • No prior cancer vaccine therapy, including participation in a vaccine study


  • At least 4 weeks since prior chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • More than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids


  • At least 4 weeks since prior radiotherapy


  • Not specified


  • No concurrent participation in another investigational study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00104780

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
Sponsors and Collaborators
Study Chair: Scott Plasman Epimmune
  More Information Identifier: NCT00104780     History of Changes
Other Study ID Numbers: CDR0000415721
Study First Received: March 3, 2005
Last Updated: November 5, 2013

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Freund's Adjuvant
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017