Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 to 80	NCI, Other	UKMC-IRB-0391-F2R UKMC-CTRF-G-01-009, NCT00103116

Objectives

1. 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.
2. Determine the potential clinical efficacy of this vaccine in these patients.

Entry 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

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

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

Expected Enrollment

A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Outcomes

Immunologic response

Comparison of clinical outcomes to historical controls

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.

Trial Contact Information

Trial Lead Organizations

Lucille P. Markey Cancer Center at University of Kentucky

Edward Hirschowitz, MD, Protocol chair		Ph: 859-257-9575

Registry Information
Official Title		Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
Trial Start Date		2004-10-15
Registered in ClinicalTrials.gov		NCT00103116
Date Submitted to PDQ		2004-12-13
Information Last Verified		2006-12-03
NCI Grant/Contract Number		CA091624