Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Lucille P. Markey Cancer Center at University of Kentucky National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00103116

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	Drug: allogeneic tumor cell vaccine Drug: therapeutic autologous dendritic cells Procedure: adjuvant therapy	Phase II

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Autologous Dendritic Cell Vaccines in Non-Small Cell Lung Cancer (NSCLC)

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Immunologic response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of clinical outcomes to historical controls [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	October 2004

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

Lucille P. Markey Cancer Center at University of Kentucky

National Cancer Institute (NCI)

Investigators

Study Chair:

Edward Hirschowitz, MD

Lucille P. Markey Cancer Center at University of Kentucky

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000410830, UKMC-IRB-0391-F2R, UKMC-CTRF-G-01-009
Study First Received:	February 7, 2005
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00103116
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Adenocarcinoma, Bronchiolo-Alveolar
Lung Neoplasms

Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009