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CompletedPhase 1NCT00601094
Official study title

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Study summary

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

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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) · Metastatic or stage IV · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 3, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Jonsson Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Jonsson Comprehensive Cancer Center
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.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→Recurrent or relapsed→
03
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
  • 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 refuses 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 SaO\_2 \> 90% on room air, PCO\_2 \< 45 mm Hg, or FEV\_1 \> 1.0 L)
  • 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 evidence of respiratory failure (defined as SaO\_2 \> 90% on room air, PCO\_2 \< 45 mm Hg, or FEV\_1 \> 1.0 liters)
  • Patients 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 ≤ 40 OR serum creatinine ≤ 2
  • Serum total bilirubin ≤ 1.5 OR serum transaminases ≤ 2.5 times upper limit of normal (ULN)
  • Negative pregnancy test
  • 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 30 days since prior radiotherapy, chemotherapy, or noncytotoxic investigational agents
Reasons someone may not be able to joinExclusion criteria
  • active CNS metastasis (i.e., progression of CNS disease during the past 30 days without intervention)
  • evidence of coagulopathy, defined as PT and/or PTT ≤ 1.5 times ULN OR platelets ≥ 100,000/mm\^3
  • evidence of leukoplakia, defined as absolute neutrophil count ≥ 1,500/mm\^3
  • evidence of respiratory failure (defined as SaO\_2 \> 90% on room air, PCO\_2 \< 45 mm Hg, or FEV\_1 \> 1.0 L)
  • NYHA class III-IV cardiac disease 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 positivity
  • hypersensitivity to any reagents used in the study
  • signs or symptoms of acute adenoviral infection (i.e., conjunctivitis or documented adenoviral upper respiratory infection)
  • prior or concurrent evidence of autoimmune disease
  • 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 AngelesLos Angeles, California
  • Jonsson Comprehensive Cancer Center at UCLALos Angeles, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 3, 2020. Always confirm current availability with the study team.

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