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

NCT00103116 | Completed Phase 2 Results

• 4 other identifiers: CDR0000410830R21CA091624UKMC-IRB-0391-F2RUKMC-CTRF-G-01-009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Alive Five Years Post Vaccine

  five years post vaccine

Study Arms (1)

Autologous dendritic cell cancer vaccine

EXPERIMENTAL

Open label nonrandomized

Biological: autologous dendritic cell cancer vaccine

Interventions

autologous dendritic cell cancer vaccine 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.

Also known as: DC vaccine, autologous DC vaccine

Autologous dendritic cell cancer vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Edward Hirschowitz: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293, United States

Location

Related 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. doi: 10.1016/j.lungcan.2007.04.002. Epub 2007 May 16.

  PMID: 17509725 RESULT

• 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.

  PMID: 15254048 RESULT

• 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.

  PMID: 19349492 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

lentiviral minigene vaccine of COVID-19 coronavirus

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Results Point of Contact

• Title: Edward Hirschowitz
• Organization: UKentucky

eahirs2@uky.edu

8596081981

Study Officials

• Edward Hirschowitz, MD

  Lucille P. Markey Cancer Center at University of Kentucky

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 7, 2005
• First Posted: February 8, 2005
• Study Start: October 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 4, 2017
• Results First Posted: April 4, 2017

Record last verified: 2017-03

Locations

US (1)