Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
18 Years
80 Years
Both
Lung Cancer
Trial Information
Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Immunologic response
Outcome Description:
Measurement of antigen specific reaction through six months post-vaccine
Outcome Time Frame:
July/2005-Oct/2007
Safety Issue:
No
Principal Investigator
Edward Hirschowitz, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Lucille P. Markey Cancer Center at University of Kentucky
Authority:
United States: Federal Government
Study ID:
CDR0000410830
NCT ID:
NCT00103116
Start Date:
October 2004
Completion Date:
Related Keywords:
- Lung Cancer
- 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
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
