Clinical trial NCT00103116: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-02-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
timeFrame: six months post vaccine
Secondary outcomes:
measure: Number of Participants Alive Five Years Post Vaccine
timeFrame: five years post vaccine
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center at University of Kentucky Chandler Medical Center
state: Kentucky
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: Edward Hirschowitz, MD
role: STUDY_CHAIR
References:
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.
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.
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.