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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00103116
• Other study ID #: CDR0000410830
• Secondary ID: R21CA091624UKMC-
• Status: Completed
• Phase: Phase 2
• First received: February 7, 2005
• Last updated: March 30, 2017
• Start date: October 2004
• Est. completion date: April 2008

Study information

• Verified date: March 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• autologous dendritic cell cancer vaccine
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.

Locations

Country	Name	City	State
United States	Markey Cancer Center at University of Kentucky Chandler Medical Center	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Edward Hirschowitz	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2007 May 16. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization	Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.	six months post vaccine
Secondary	Number of Participants Alive Five Years Post Vaccine	Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine	five years post vaccine