This trial is active, not recruiting.

Condition lung cancer
Treatment therapeutic autologous dendritic cells
Phase phase 2
Sponsor University of Kentucky
Collaborator National Cancer Institute (NCI)
Start date October 2004
End date April 2008
Trial size 60 participants
Trial identifier NCT00103116, CDR0000410830, R21CA091624, UKMC-CTRF-G-01-009, UKMC-IRB-0391-F2R


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
therapeutic autologous dendritic cells
Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.

Primary Outcomes

Immunologic response
time frame: July/2005-Oct/2007

Secondary Outcomes

Comparison of clinical outcomes to historical controls
time frame: July/2005-May/2012

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of Kentucky.