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

June 21, 2023 updated by: Eastern Cooperative Oncology Group

Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Evaluate the safety of multiple endobronchial treatments with adenovirus p53 bronchoalveolar lavage of a single lobe of the lung in patients with bronchoalveolar cell lung carcinoma.
  • Evaluate expression of the p53 gene and induction of apoptosis in tumor and normal tissues exposed to the virus in these patients.
  • Evaluate whether transbronchial administration of adenovirus p53 results in improved local tumor control in these patients.

OUTLINE: This is a dose escalation study.

Patients undergo biopsy and receive adenovirus p53 by bronchoalveolar lavage on days 1 and 15. Patients repeat biopsy on days 3 and 28. If there is evidence of clinical benefit or response without significant toxicity, patients may receive a maximum of 3 courses. Treatment beyond 3 courses must be approved by protocol investigator.

Cohorts of 3 patients are treated at escalating dose levels of adenovirus p53. Patients in each cohort are followed for dose limiting toxicity (DLT) for 2 weeks after completion of one course before dose escalation proceeds in subsequent cohorts. If 1 of 3 patients at a dose level experiences dose limiting toxicity (DLT), then 2 additional patients are entered at the same dose level. If more than 1 of 5 patients experience DLT, the previous dose is the maximum tolerated dose (MTD). An additional 10 patients are treated at the MTD.

Patients are followed every 3 months for the first 2 years, every 6 months for the next 3 years, and annually thereafter.

PROJECTED ACCRUAL: There will be 15 patients accrued into this study over 1 year.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37212
        • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • CCOP - Green Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David P. Carbone, MD, PhD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 1998

Study Completion (Actual)

June 15, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

April 29, 2003

First Posted (Estimated)

April 30, 2003

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066741
  • E-6597

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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