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
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 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 July 20, 2014