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

Completed · Phase 1

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00601094

Run by

Jonsson Comprehensive Cancer Center

People needed

17

Starts

2009-02-26

Expected to finish

2017-05-23

Last updated by the study team

2020-08-03

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Greater Los Angeles — Los Angeles, California, United States
• Jonsson Comprehensive Cancer Center at UCLA — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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