CClinicalTrials.gg
Status unknownNCT00104780Updated Nov 6, 2013

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

A Phase 2 interventional study of EP-2101 and incomplete Freund's adjuvant in Lung Cancer, sponsored by Epimmune. Status unknown at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-06.

Sponsored by Epimmune · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Lung Cancer

Keywords

  • recurrent non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

Browse Lung Neoplasms studies →

Lead sponsor

Epimmune is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • BiologicalEP-2101
  • Biologicalincomplete Freund's adjuvant
06

What researchers measure

Primary outcomes

  1. Comparison of overall survival with historical controls

  2. Safety

Secondary outcomes

  1. Progression-free survival

  2. Frequency, magnitude, and breadth of cytotoxic and helper T-cell response to vaccine epitopes

07

Study locations

9 sites
  • Cancer Centers of Florida - Ocoee
    Ocoee, Florida 34761, United States
  • New York Oncology Hematology, P. C. at Albany Regional Cancer Care
    Albany, New York 12208, United States
  • Duke Comprehensive Cancer Center
    Durham, North Carolina 27710, United States
  • Dayton Oncology & Hematology, P.A. - Kettering
    Kettering, Ohio 45409, United States
  • Cancer Centers of the Carolinas - Eastside
    Greenville, South Carolina 29615, United States
  • Sarah Cannon Cancer Center at Centennial Medical Center
    Nashville, Tennessee 37203, United States
  • Mary Crowley Medical Research Center at Sammons Cancer Center
    Dallas, Texas 75246, United States
  • Tyler Cancer Center
    Tyler, Texas 75702, United States
  • Cancer Care Northwest - North
    Spokane, Washington 99218, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00104780
Lead sponsor
Epimmune
First posted
Mar 4, 2005
Start date
Dec 2004
Last update
Nov 6, 2013

Study contacts

Scott Plasman
study chair · Epimmune
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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