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TerminatedPhase 1NCT01574222
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedautologous dendritic cell adenovirus CCL21 vaccine

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 18, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?VA Office of Research and Development

Study sponsor

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Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
VA Office of Research and Development
Interventions being studied
Biological: autologous dendritic cell adenovirus CCL21 vaccine
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Recurrent or relapsed→
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Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 18, 2018. Always confirm current availability with the study team.

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