Lung CancerPhase 1NCT00601094
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
A Phase 1 study testing autologous dendritic cell-adenovirus CCL21 vaccine in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- 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
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Feb 2009to 23 May 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
- 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 refuses standard chemotherapy
- Measurable metastatic disease by RECIST guidelines
- 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 SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
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- 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 evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 liters)
- Patients 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 ≤ 40 OR serum creatinine ≤ 2
- Serum total bilirubin ≤ 1.5 OR serum transaminases ≤ 2.5 times upper limit of normal (ULN)
- Negative pregnancy test
- 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 30 days since prior radiotherapy, chemotherapy, or noncytotoxic investigational agents
Who cannot join
- active CNS metastasis (i.e., progression of CNS disease during the past 30 days without intervention)
- evidence of coagulopathy, defined as PT and/or PTT ≤ 1.5 times ULN OR platelets ≥ 100,000/mm^3
- evidence of leukoplakia, defined as absolute neutrophil count ≥ 1,500/mm^3
- evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
- NYHA class III-IV cardiac disease 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 positivity
- hypersensitivity to any reagents used in the study
- signs or symptoms of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
- prior or concurrent evidence of autoimmune disease
- pregnant or nursing
- prior organ allograft
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Greater Los Angeles
Los Angeles, California, 90073
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase I Trial of CCL21 Gene Modified Dendritic Cells In Non-Small Cell Lung Cancer
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the safety, toxicity, and maximum tolerated dose (MTD) of autologous dendritic cell-adenovirus 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 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).
OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus CCL21 vaccine.
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Adenovirus carrying the CCL21 gene is added to the dendritic cells to make the vaccine. Approximately 2 weeks after leukapheresis, patients receive an intratumoral injection of autologous dendritic cell-adenovirus CCL21 vaccine under CT-guidance or by bronchoscopy on days 0 and 7. Patients demonstrating a clinical response are eligible to receive a second round of gene transfer at their discretion and in consultation with the FDA.
Cohorts of 3 patients receive escalating doses of autologous dendritic cell-adenovirus CCL21 vaccine until the maximum tolerated dose (MTD) is determined. An additional 12 patients are treated at the MTD.
Patients undergo blood sample collection at baseline and then on days 0, 7, 14, 28, and 56 for safety and immunological studies. Blood samples are analyzed for mycoplasma by PCR; dendritic cell phenotype by flow cytometry; detection of adenovirus CCL21 by nested PCR; and adenoviral antibodies by ELISA. Patients also undergo tissue aspirate or biopsy on days 0 and 7 (during bronchoscopy or CT-guided procedure). Tissue samples are analyzed for immune-modulating cytokines (i.e., IFNγ, CXCL9, and CXCL10) by quantitative RT-PCR; detection of tumor infiltrating leukocytes by immunohistochemistry; CD83+ DC, CXCR3, CCR7, CCL21 and CD3+ T-cells, CD4, and CD8 by flow cytometry; determination of tumor expression of tumor-associated antigen by RT-PCR; and evaluation of immune modulation by ELISPOT assays.
After completion of study treatment, patients are followed periodically.
- Conditions
- Lung Cancer
- Being tested
- autologous dendritic cell-adenovirus CCL21 vaccine
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
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
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 |
|---|---|---|
| experimental arm | Experimental | Not described 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
Measured: 28 days
Toxicity as measured by NCI Common Toxicity Criteria
Measured: 28 days
Secondary outcomes (2)
Disease status at days 28 and 56
Measured: 56 days
Immune response assessment by antigen-specific IFNγ ELISPOT assays on days 0, 28, and 56
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study start26 Feb 2009
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay M. Lee, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601094
- Sponsor's protocol ID
- 03-06-008
- Other IDs
- UCLA-NCI-7888, 10-000039
- Status last verified
- Oct 2017
- First submitted
- 10 Jan 2008
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of CCL21 Gene Modified Dendritic Cells In Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00601094
- Acronym / sponsor ID
- 03-06-008
- Conditions
- Lung Cancer
- Keywords
- stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 26 Feb 2009 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 25 Jan 2008 (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.
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the safety, toxicity, and maximum tolerated dose (MTD) of autologous dendritic cell-adenovirus 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 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).
OUTLINE: This is a dose-escalation study of autologous dendritic cell-adenovirus CCL21 vaccine.
Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Adenovirus carrying the CCL21 gene is added to the dendritic cells to make the vaccine. Approximately 2 weeks after leukapheresis, patients receive an intratumoral injection of autologous dendritic cell-adenovirus CCL21 vaccine under CT-guidance or by bronchoscopy on days 0 and 7. Patients demonstrating a clinical response are eligible to receive a second round of gene transfer at their discretion and in consultation with the FDA.
Cohorts of 3 patients receive escalating doses of autologous dendritic cell-adenovirus CCL21 vaccine until the maximum tolerated dose (MTD) is determined. An additional 12 patients are treated at the MTD.
Patients undergo blood sample collection at baseline and then on days 0, 7, 14, 28, and 56 for safety and immunological studies. Blood samples are analyzed for mycoplasma by PCR; dendritic cell phenotype by flow cytometry; detection of adenovirus CCL21 by nested PCR; and adenoviral antibodies by ELISA. Patients also undergo tissue aspirate or biopsy on days 0 and 7 (during bronchoscopy or CT-guided procedure). Tissue samples are analyzed for immune-modulating cytokines (i.e., IFNγ, CXCL9, and CXCL10) by quantitative RT-PCR; detection of tumor infiltrating leukocytes by immunohistochemistry; CD83+ DC, CXCR3, CCR7, CCL21 and CD3+ T-cells, CD4, and CD8 by flow cytometry; determination of tumor expression of tumor-associated antigen by RT-PCR; and evaluation of immune modulation by ELISPOT assays.
After completion of study treatment, patients are followed periodically.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental arm | Experimental | Biological: autologous dendritic cell-adenovirus CCL21 vaccine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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 refuses standard chemotherapy
- Measurable metastatic disease by RECIST guidelines
Key exclusion criteria (14 listed)
- active CNS metastasis (i.e., progression of CNS disease during the past 30 days without intervention)
- evidence of coagulopathy, defined as PT and/or PTT ≤ 1.5 times ULN OR platelets ≥ 100,000/mm^3
- evidence of leukoplakia, defined as absolute neutrophil count ≥ 1,500/mm^3
- evidence of respiratory failure (defined as SaO_2 > 90% on room air, PCO_2 < 45 mm Hg, or FEV_1 > 1.0 L)
- NYHA class III-IV cardiac disease 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 vaccineEligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling. | Biological | experimental arm |
Primary outcome
Maximum tolerated dose
Time frame: 28 days
Toxicity as measured by NCI Common Toxicity Criteria
Time frame: 28 days
2 secondary outcomes
Disease status at days 28 and 56
Time frame: 56 days
Immune response assessment by antigen-specific IFNγ ELISPOT assays on days 0, 28, and 56
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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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.
Jay M. Lee, MD study chair
Jonsson Comprehensive Cancer Center
2 sites 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 Lung Cancer, run by Jonsson Comprehensive Cancer Center at 2 sites 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 16 inclusion and 14 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: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2020.