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A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer (VTNSCLC)

This study has been terminated.
(Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure))
Sponsor:
ClinicalTrials.gov Identifier:
NCT01574222
First Posted: April 10, 2012
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention Phase
Non-Small Cell Lung Cancer (NSCLC) Biological: autologous dendritic cell adenovirus CCL21 vaccine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
No masking
Primary Purpose: Treatment
Official Title: Intratumoral Genetic Therapy for Lung Cancer

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
    Toxicity as measured by NCI Common Toxicity Criteria


Secondary Outcome Measures:
  • 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


Enrollment: 16
Actual Study Start Date: October 1, 2011
Study Completion Date: March 1, 2017
Primary Completion Date: March 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: autologous dendritic cell adenovirus CCL21 vaccine
Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
Other Name: 10-000039, UCLA-NCI 7888, 03-06-008

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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574222


Locations
United States, California
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Steven Dubinett, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01574222     History of Changes
Other Study ID Numbers: CLIN-004-09F
First Submitted: March 28, 2012
First Posted: April 10, 2012
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
Stages IIIB, IV, and recurrent NSCLC
Carcinoma, Non-small cell lung
Lung Neoplasms
Carcinoma, Bronchogenic
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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