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

November 5, 2013 updated by: Epimmune

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ocoee, Florida, United States, 34761
        • Cancer Centers of Florida - Ocoee
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P. C. at Albany Regional Cancer Care
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology & Hematology, P.A. - Kettering
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Cancer Centers of the Carolinas - Eastside
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Cancer Center at Centennial Medical Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Mary Crowley Medical Research Center at Sammons Cancer Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Washington
      • Spokane, Washington, United States, 99218
        • Cancer Care Northwest - North

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 weeks

Hematopoietic

  • 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

Hepatic

  • 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

Renal

  • Creatinine ≤ 2 times ULN

Immunologic

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy

  • 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

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • Not specified

Other

  • No concurrent participation in another investigational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Comparison of overall survival with historical controls

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epimmune

Investigators

  • Study Chair: Scott Plasman, Epimmune

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000415721
  • EPIMMUNE-EP2101-201
  • MCMRC-0461

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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