A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer (VTNSCLC)
January 16, 2018 updated by: VA Office of Research and Development
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
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West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Arm 1
Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling
|
Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum Tolerated Dose (MTD)
Time Frame: 28 Days
|
Toxicity as measured by NCI Common Toxicity Criteria
|
28 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease status at days 28 and 56 days
Time Frame: 28 and 56 Days
|
Immune response assessment by antigen-specific interferon gamma (IFNy) Enzyme-Linked ImmunoSpot (ELISPOT) assays on days 0, 28, and 56
|
28 and 56 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven Dubinett, MD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2011
Primary Completion (ACTUAL)
March 1, 2017
Study Completion (ACTUAL)
March 1, 2017
Study Registration Dates
First Submitted
March 28, 2012
First Submitted That Met QC Criteria
April 5, 2012
First Posted (ESTIMATE)
April 10, 2012
Study Record Updates
Last Update Posted (ACTUAL)
January 18, 2018
Last Update Submitted That Met QC Criteria
January 16, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-004-09F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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