Lung CancerPhase 2NCT00103116
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
A Phase 2 study testing autologous dendritic cell cancer vaccine in people with Lung Cancer, run by Edward Hirschowitz at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- autologous dendritic cell cancer vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0293
About this study
Official title: Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
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.
Read the 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
- Being tested
- autologous dendritic cell cancer vaccine
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous dendritic cell cancer vaccineBiological
Also called DC vaccine, autologous DC 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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous dendritic cell cancer vaccine | Experimental | Open label nonrandomized Receives: Biological: autologous dendritic cell cancer vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months post vaccine
Secondary outcomes (1)
Number of Participants Alive Five Years Post Vaccine
Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine
Measured: five years post vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2005 (estimated)
- Study startOct 2004
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Hirschowitz
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Edward Hirschowitz, University of Kentucky
- Investigators
- Edward Hirschowitz, MD, Study chair, Lucille P. Markey Cancer Center at University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103116
- Sponsor's protocol ID
- CDR0000410830
- Other IDs
- R21CA091624, UKMC-IRB-0391-F2R, UKMC-CTRF-G-01-009
- Status last verified
- Mar 2017
- First submitted
- 7 Feb 2005
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 17509725Hirschowitz 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.
PubMed 15254048Hirschowitz EA, Yannelli JR. Immunotherapy for lung cancer. Proc Am Thorac Soc. 2009 Apr 15;6(2):224-32. doi: 10.1513/pats.200806-048LC.
PubMed 19349492
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT00103116
- Acronym / sponsor ID
- CDR0000410830
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Edward HirschowitzUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 8 Feb 2005 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous dendritic cell cancer vaccine | Experimental | Biological: autologous dendritic cell cancer vaccineOpen label nonrandomized |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous dendritic cell cancer vaccineAlso: DC vaccine, autologous DC vaccineDendritic 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. | Biological | Autologous dendritic cell cancer vaccine |
Primary outcome
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization
Time frame: six months post vaccine
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.
1 secondary outcome
Number of Participants Alive Five Years Post Vaccine
Time frame: five years post vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17509725Hirschowitz 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.
- Results publication: PubMed 15254048Hirschowitz 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.
- Results publication: PubMed 19349492Hirschowitz EA, Yannelli JR. Immunotherapy for lung cancer. Proc Am Thorac Soc. 2009 Apr 15;6(2):224-32. doi: 10.1513/pats.200806-048LC.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Hirschowitz, MD study chair
Lucille P. Markey Cancer Center at University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous dendritic cell cancer vaccine in people with Lung Cancer, run by Edward Hirschowitz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization (time frame: six months post vaccine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00103116, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.