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

NCT00601094 | Completed Phase 1 DMC

• 3 other identifiers: 03-06-008UCLA-NCI-788810-000039
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose

  28 days

• Toxicity as measured by NCI Common Toxicity Criteria

  28 days

Secondary Outcomes (2)

• Disease status at days 28 and 56

  56 days

• Immune response assessment by antigen-specific IFNγ ELISPOT assays on days 0, 28, and 56

  56 days

Study Arms (1)

experimental arm

EXPERIMENTAL

Biological: autologous dendritic cell-adenovirus CCL21 vaccine

Interventions

autologous dendritic cell-adenovirus CCL21 vaccine BIOLOGICAL

Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.

experimental arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (2)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Jay M. Lee, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 25, 2008
• Study Start: February 26, 2009
• Primary Completion: May 23, 2017
• Study Completion: May 23, 2017
• Last Updated: August 3, 2020

Record last verified: 2017-10

Locations

US (2)