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CompletedPhase 1NCT00003649
Official study title

Gene Therapy in Treating Patients With Non-small Cell Lung Cancer That Cannot Be Surgically Removed

Study summary

RATIONALE: Exposing tumor cells to the p53 gene may improve the body's ability to fight non-small cell lung cancer. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have non-small cell lung cancer that cannot be surgically removed.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAd5CMV-p53 gene

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 22, 2023 · 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?3 U.S. locations

Locations may change over time.

Who runs it?Eastern Cooperative Oncology Group

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Eastern Cooperative Oncology Group
Interventions being studied
Biological: Ad5CMV-p53 gene
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)→
Treatment approach
Surgery→Cell or gene therapy→
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
  • DISEASE CHARACTERISTICS:
  • Histologically confirmed unresectable non-small cell lung cancer with a growth pattern allowing access to the majority of tumor cells via the airway (e.g., bronchioloalveolar or papillary adenocarcinoma) PATIENT CHARACTERISTICS: Age:
  • 18 and over Performance status:
  • ECOG 0-1 Life expectancy:
  • At least 12 weeks Hematopoietic:
  • Platelet count greater than 100,000/mm\^3
  • Prothrombin time and partial thromboplastin time normal Hepatic:
  • Bilirubin less than 1.5 mg/dL Renal:
  • Creatinine less than 1.5 mg/dL Cardiovascular:
  • No New York Heart Association class III or IV heart disease Pulmonary:
  • Room air oxygen saturation greater than 90%
  • FEV1 greater than 1.0 L pCO2 less than 50 Other:
  • HIV negative
  • No active systemic viral, bacterial, or fungal infections requiring treatment
  • No concurrent illness requiring hospitalization or intravenous medication
  • Not pregnant or nursing
  • Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy:
  • No prior adenovirus gene therapy
  • At least 2 weeks since any systemic biologic therapy including prior biologic response modifiers and recovered Chemotherapy:
  • At least 2 weeks since any prior systemic chemotherapy and recovered Endocrine therapy:
  • Recovered from any prior endocrine therapy Radiotherapy:
  • Recovered from any prior radiotherapy Surgery:
  • At least 2 weeks since any surgical procedure requiring anesthesia
  • At least 4 weeks since prior surgical resection of lung tissues Other:
  • No other concurrent therapy

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

  • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee
  • Vanderbilt-Ingram Cancer CenterNashville, Tennessee
  • CCOP - Green BayGreen Bay, Wisconsin

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 22, 2023. Always confirm current availability with the study team.

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