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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01574222
First received: March 28, 2012
Last updated: July 24, 2014
Last verified: July 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intratumoral Genetic Therapy for Lung Cancer

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Immune response assessment by antigen-specific IFNy ELISPOT assays on days 0, 28, and 56


Enrollment: 16
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (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 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574222

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01574222     History of Changes
Other Study ID Numbers: CLIN-004-09F
Study First Received: March 28, 2012
Last Updated: July 24, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014