TerminatedPhase 1NCT01574222

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

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

StatusTerminated
PhasePhase 1
U.S. locations1
SponsorVA Office of Research and Development
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

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

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

04
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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