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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA091624 | U.S. NIH Grant/Contract | View source | |
| UKMC-IRB-0391-F2R | Other Identifier | IRB | |
| UKMC-CTRF-G-01-009 | Other Grant/Funding Number | Cancer Treatment Research Foundation |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous dendritic cell cancer vaccine | Experimental | Open label nonrandomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer (NSCLC)
Meets 1 of the following stage criteria:
Completely resected stage I-IIIB disease
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 malignant pleural or pericardial effusions
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Edward Hirschowitz, MD | Lucille P. Markey Cancer Center at University of Kentucky | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536-0293 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17509725 | Result | 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. | |
| 15254048 | 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. |
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None excluded; all completed.
Non-randomized open label; stage I-IIIB NSCLC. Closed to accrual in 2006 when defined phase I immunological endpoints were reached.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vaccine | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vaccine | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants with immunological response | six months post vaccine |
|
five years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaccine | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| injection site reaction | General disorders | Non-systematic Assessment | Self limited injection site reaction was observed in half the study participants |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Hirschowitz | UKentucky | 8596081981 | eahirs2@uky.edu |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000706173 | lentiviral minigene vaccine of COVID-19 coronavirus |
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|
| 19349492 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants Alive Five Years Post Vaccine | Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine | Posted | Number | participants | five years post vaccine |
|
|
|
| 0 |
| 32 |
| 16 |
| 32 |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |