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

NCT ID: NCT00103116

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-04-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous dendritic cell cancer vaccine

Open label nonrandomized

Group Type: EXPERIMENTAL

autologous dendritic cell cancer vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

DC vaccine; autologous DC vaccine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Edward Hirschowitz

OTHER

Sponsor Role: lead

Responsible Party

Edward Hirschowitz

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Edward Hirschowitz, MD

Role: STUDY_CHAIR

Lucille P. Markey Cancer Center at University of Kentucky

Locations

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17509725 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15254048 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19349492 (View on PubMed)

Other Identifiers

R21CA091624

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UKMC-IRB-0391-F2R

Identifier Type: OTHER

Identifier Source: secondary_id

UKMC-CTRF-G-01-009

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDR0000410830

Identifier Type: -

Identifier Source: org_study_id