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Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Lung Cancer

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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 CenterLexington, Kentucky  40536-0084