search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
autologous dendritic cell cancer vaccine
Sponsored by
Edward Hirschowitz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous dendritic cell cancer vaccine

Arm Description

Open label nonrandomized

Outcomes

Primary Outcome Measures

Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.

Secondary Outcome Measures

Number of Participants Alive Five Years Post Vaccine
Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine

Full Information

First Posted
February 7, 2005
Last Updated
March 30, 2017
Sponsor
Edward Hirschowitz
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00103116
Brief Title
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Official Title
Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward Hirschowitz
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous dendritic cell cancer vaccine
Arm Type
Experimental
Arm Description
Open label nonrandomized
Intervention Type
Biological
Intervention Name(s)
autologous dendritic cell cancer vaccine
Other Intervention Name(s)
DC vaccine, autologous DC vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
Description
Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.
Time Frame
six months post vaccine
Secondary Outcome Measure Information:
Title
Number of Participants Alive Five Years Post Vaccine
Description
Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine
Time Frame
five years post vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Hirschowitz, MD
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Study Chair
Facility Information:
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17509725
Citation
Hirschowitz EA, Foody T, Hidalgo GE, Yannelli JR. Immunization of NSCLC patients with antigen-pulsed immature autologous dendritic cells. Lung Cancer. 2007 Sep;57(3):365-72. doi: 10.1016/j.lungcan.2007.04.002. Epub 2007 May 16.
Results Reference
result
PubMed Identifier
15254048
Citation
Hirschowitz EA, Foody T, Kryscio R, Dickson L, Sturgill J, Yannelli J. Autologous dendritic cell vaccines for non-small-cell lung cancer. J Clin Oncol. 2004 Jul 15;22(14):2808-15. doi: 10.1200/JCO.2004.01.074.
Results Reference
result
PubMed Identifier
19349492
Citation
Hirschowitz EA, Yannelli JR. Immunotherapy for lung cancer. Proc Am Thorac Soc. 2009 Apr 15;6(2):224-32. doi: 10.1513/pats.200806-048LC.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs