Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT00103116
First received: February 7, 2005
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells 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 I, stage II, or stage III non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Biological: therapeutic autologous dendritic cells
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Immunologic response [ Time Frame: July/2005-Oct/2007 ] [ Designated as safety issue: No ]
    Measurement of antigen specific reaction through six months post-vaccine


Secondary Outcome Measures:
  • Comparison of clinical outcomes to historical controls [ Time Frame: July/2005-May/2012 ] [ Designated as safety issue: No ]
    Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine


Estimated Enrollment: 60
Study Start Date: October 2004
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vaccine Biological: therapeutic autologous dendritic cells

Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure.

Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.


Detailed Description:

OBJECTIVES:

  • Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.
  • Determine the potential clinical efficacy of this vaccine in these patients.

OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical).

Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity.

Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC)

    • Meets 1 of the following stage criteria:

      • Completely resected stage I-IIIB disease

        • Underwent surgical resection > 4 weeks but ≤ 4 years ago
      • Unresectable stage IIIA or IIIB disease AND previously treated with definitive radiotherapy or chemotherapy > 6 weeks ago
    • Bronchoalveolar carcinomas allowed
  • Clinically stable disease by chest x-ray or CT scan within the past 6 weeks

    • No progressive disease
  • No malignant pleural or pericardial effusions

PATIENT CHARACTERISTICS:

Age

  • 18 to 80

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Hemoglobin ≥ 9.0 g/dL

Hepatic

  • Bilirubin ≤ 2.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No known history of infectious hepatitis

Renal

  • Creatinine ≤ 3 mg/dL
  • Ionized calcium ≥ 0.9 mmol/L (may be replaced)

Cardiovascular

  • No known New York Heart Association class III-IV congestive heart failure
  • No hemodynamically significant valvular heart disease
  • No myocardial infarction within the past 6 months
  • No active angina pectoris
  • No uncontrolled ventricular arrhythmia
  • No stroke within the past year
  • No known cerebrovascular disease
  • No other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam)

Immunologic

  • No known HIV positivity
  • No other immunosuppressive disorders, including chronic disorders

Other

  • Not pregnant
  • Negative pregnancy test
  • Potassium ≥ 3.0 mEq/L (may be replaced)
  • Able to tolerate modest blood volume and electrolyte shifts during leukapheresis
  • No other malignancy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior biologic therapy allowed
  • Other concurrent biologic therapy allowed

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent steroids during and for 16 weeks after study treatment

Radiotherapy

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics

Other

  • Prior neoadjuvant or adjuvant therapy for surgically resected patients allowed
  • No concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
  • No concurrent chronic immunosuppressive medications
  • Concurrent cyclooxygenase-2 inhibitors allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103116

Locations
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
Sponsors and Collaborators
University of Kentucky
Investigators
Study Chair: Edward Hirschowitz, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Additional Information:
No publications provided

Responsible Party: University of Kentucky
ClinicalTrials.gov Identifier: NCT00103116     History of Changes
Other Study ID Numbers: CDR0000410830, R21CA091624, UKMC-IRB-0391-F2R, UKMC-CTRF-G-01-009
Study First Received: February 7, 2005
Last Updated: February 21, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by University of Kentucky:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014