Non-Small Cell Lung Cancer (NSCLC)Phase 1VTNSCLCNCT01574222
A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer
A Phase 1 study testing autologous dendritic cell adenovirus CCL21 vaccine in people with Non-Small Cell Lung Cancer (NSCLC), run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- autologous dendritic cell adenovirus CCL21 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2011to 1 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening, physical exams, blood draws, CT scans, and follow-up will be performed at VA Greater Los Angeles. All interventional procedures including leukapheresis, CT guided/bronchoscopic biopsies and vaccine injections will be performed at University of California Los Angeles (UCLA).
- Adults over the age of 21 capable of giving informed consent
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB, IV or recurrent disease
- Progressive disease despite one or more prior chemotherapy regimens as standard of care OR patient refusal of standard chemotherapy
- Measurable metastatic disease by RECIST guidelines
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- Patients with a major endobronchial lesion in the segmental, lobar, or mainstem bronchus with complete obstruction of the airway may be eligible for bronchoscopic injection provided there is no evidence of respiratory failure (defined as SaO2 at least 90% on room air, PCO2 less than, or equal to 45 mm Hg, or FEV1 greater than 1.0L)
- Patients with an endobronchial lesion in the segmental bronchus with variable stenosis (not completely obstructed) and not amenable to standard palliative airway treatments (i.e., laser and stenting) may be eligible for bronchoscopic injection if there is no indication of respiratory failure as defined above
- Patient with bullous disease may undergo CT-guided transthoracic injection provided the targeted tumor has an intended needle path without crossing bullae
- ECOG performance status 0-2
- BUN less than or equal to 40 OR serum creatinine less than 2 Serum total bilirubin less than or equal to 1.5 OR serum transaminases less than or equal to 2.5 times upper limit of normal (ULN)
- Negative pregnancy test (if applicable)
- Fertile patients must use effective contraception
- More than 14 days since prior acute therapy for viral, bacterial, or fungal infections
- More than 30 days since prior and no concurrent corticosteroids
- More than 15 days since prior radiotherapy
- More than 30 days since prior chemotherapy, or non-cytotoxic investigational agents
Who cannot join
- Active CNS metastases (i.e., progression of CNS disease during the past 30 days without intervention)
- Evidence of coagulopathy, defined as PT and/or PTT more than 1.5 times ULN or platelets more than or equal to 100,000/mm3.
- Evidence of leukoplakia, defined as absolute neutrophil count more than or equal to 1,500/mm3
- Evidence of respiratory failure (defined as SaO2 less than 90% on room air, PCO2 more than 45 mm Hg, or FEV1 less than 1.0 L
- NYHA class III-IV within the past year
- Myocardial infarction within the past year
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- Comorbid disease or medical condition that would impair the ability of the patient to receive or comply with the study protocol
- Acute viral, bacterial or fungal infection that requires specific therapy
- HIV positive
- Hypersensitivity to any reagents used in the study
- Signs or sensitivity of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
- Pregnant or nursing
- Prior organ allograft
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
Official title: Intratumoral Genetic Therapy for Lung Cancer
The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.
Read the detailed description
Primary
- to determine the safety, toxicity, and Maximum Tolerated Dose (MTD) of autologous dendritic cell-adenovirus chemokine (C-C motif) ligand 21 (CCL21) vaccine administered as an intratumoral injection in treating patients with stage IIIB, IV, or recurrent non-small cell lung cancer
Secondary
- to determine the biologic and clinical responses to therapy
- to determine treatment-related toxicity using the NCI Common Toxicity Criteria
- to identify the maximum tolerated dose (MTD)
- to monitor patients for evidence of autologous dendritic cell-adenovirus CCL21 vaccine-induced cytokines and antigen-specific immune responses
- to detect immune responses to tumor-associated antigens and vector
- to assess patients for objective signs of tumor regression (RECIST criteria)
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- autologous dendritic cell adenovirus CCL21 vaccine
- Keywords
- Stages IIIB, IV, and recurrent NSCLC, Carcinoma, Non-small cell lung, Lung Neoplasms, Carcinoma, Bronchogenic, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Carcinoma, Bronchogenic, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous dendritic cell adenovirus CCL21 vaccineBiological
Also called 10-000039, UCLA-NCI 7888, 03-06-008
Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling Receives: Biological: autologous dendritic cell adenovirus CCL21 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Toxicity as measured by NCI Common Toxicity Criteria
Measured: 28 Days
Secondary outcomes (1)
Disease status at days 28 and 56 days
Immune response assessment by antigen-specific interferon gamma (IFNy) Enzyme-Linked ImmunoSpot (ELISPOT) assays on days 0, 28, and 56
Measured: 28 and 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study start1 Oct 2011
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Why it stopped: Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven Dubinett, MD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574222
- Sponsor's protocol ID
- CLIN-004-09F
- Acronym
- VTNSCLC
- Status last verified
- Jan 2018
- First submitted
- 28 Mar 2012
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee JM, Lee MH, Garon E, Goldman JW, Salehi-Rad R, Baratelli FE, Schaue D, Wang G, Rosen F, Yanagawa J, Walser TC, Lin Y, Park SJ, Adams S, Marincola FM, Tumeh PC, Abtin F, Suh R, Reckamp KL, Lee G, Wallace WD, Lee S, Zeng G, Elashoff DA, Sharma S, Dubinett SM. Phase I Trial of Intratumoral Injection of CCL21 Gene-Modified Dendritic Cells in Lung Cancer Elicits Tumor-Specific Immune Responses and CD8+ T-cell Infiltration. Clin Cancer Res. 2017 Aug 15;23(16):4556-4568. doi: 10.1158/1078-0432.CCR-16-2821. Epub 2017 May 3.
PubMed 28468947
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intratumoral Genetic Therapy for Lung Cancer
- ClinicalTrials.gov ID
- NCT01574222
- Acronym / sponsor ID
- VTNSCLC / CLIN-004-09F
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Keywords
- Stages IIIB, IV, and recurrent NSCLC, Carcinoma, Non-small cell lung, Lung Neoplasms, Carcinoma, Bronchogenic, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
- Enrolment
- 1 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Jonsson Comprehensive Cancer Center, National Cancer Institute (NCI)
- Study start
- 1 Oct 2011 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 10 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.
Detailed description
Primary
- to determine the safety, toxicity, and Maximum Tolerated Dose (MTD) of autologous dendritic cell-adenovirus chemokine (C-C motif) ligand 21 (CCL21) vaccine administered as an intratumoral injection in treating patients with stage IIIB, IV, or recurrent non-small cell lung cancer
Secondary
- to determine the biologic and clinical responses to therapy
- to determine treatment-related toxicity using the NCI Common Toxicity Criteria
- to identify the maximum tolerated dose (MTD)
- to monitor patients for evidence of autologous dendritic cell-adenovirus CCL21 vaccine-induced cytokines and antigen-specific immune responses
- to detect immune responses to tumor-associated antigens and vector
- to assess patients for objective signs of tumor regression (RECIST criteria)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: autologous dendritic cell adenovirus CCL21 vaccineEligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Screening, physical exams, blood draws, CT scans, and follow-up will be performed at VA Greater Los Angeles. All interventional procedures including leukapheresis, CT guided/bronchoscopic biopsies and vaccine injections will be performed at University of California Los Angeles (UCLA).
- Adults over the age of 21 capable of giving informed consent
- Pathologically confirmed non-small cell lung cancer (NSCLC)
- Stage IIIB, IV or recurrent disease
- Progressive disease despite one or more prior chemotherapy regimens as standard of care OR patient refusal of standard chemotherapy
Key exclusion criteria (13 listed)
- Active CNS metastases (i.e., progression of CNS disease during the past 30 days without intervention)
- Evidence of coagulopathy, defined as PT and/or PTT more than 1.5 times ULN or platelets more than or equal to 100,000/mm3.
- Evidence of leukoplakia, defined as absolute neutrophil count more than or equal to 1,500/mm3
- Evidence of respiratory failure (defined as SaO2 less than 90% on room air, PCO2 more than 45 mm Hg, or FEV1 less than 1.0 L
- NYHA class III-IV within the past year
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 adenovirus CCL21 vaccineAlso: 10-000039, UCLA-NCI 7888, 03-06-008Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling. | Biological | Arm 1 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 Days
Toxicity as measured by NCI Common Toxicity Criteria
1 secondary outcome
Disease status at days 28 and 56 days
Time frame: 28 and 56 Days
Results and safety
The study was stopped early (reason given: Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 28468947Lee JM, Lee MH, Garon E, Goldman JW, Salehi-Rad R, Baratelli FE, Schaue D, Wang G, Rosen F, Yanagawa J, Walser TC, Lin Y, Park SJ, Adams S, Marincola FM, Tumeh PC, Abtin F, Suh R, Reckamp KL, Lee G, Wallace WD, Lee S, Zeng G, Elashoff DA, Sharma S, Dubinett SM. Phase I Trial of Intratumoral Injection of CCL21 Gene-Modified Dendritic Cells in Lung Cancer Elicits Tumor-Specific Immune Responses and CD8+ T-cell Infiltration. Clin Cancer Res. 2017 Aug 15;23(16):4556-4568. doi: 10.1158/1078-0432.CCR-16-2821. Epub 2017 May 3.
- Click here for more information about this study: Intratumoral genetic therapy for lung cancerLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Steven Dubinett, MD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous dendritic cell adenovirus CCL21 vaccine in people with Non-Small Cell Lung Cancer (NSCLC), run by VA Office of Research and Development 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?
The sponsor lists 17 inclusion and 13 exclusion criteria. 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: stopped early, as of the sponsor's last update on 18 Jan 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)). Results are not available in the source record.
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?
Maximum Tolerated Dose (MTD) (time frame: 28 Days). 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 NCT01574222, which also lists 1 linked publication.
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 18 Jan 2018.