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Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage (NCT00003649)

National Cancer Institute (NCI)
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.
  • Biological: Ad5CMV-p53 gene
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    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.

    3 locations

    United States (3)
    • Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
      Nashville, Tennessee, United States, 37212
    • Vanderbilt-Ingram Cancer Center
      Nashville, Tennessee, United States, 37232-6838
    • CCOP - Green Bay
      Green Bay, Wisconsin, United States, 54301
    Status:
    completed
    Type:
    Interventional
    Phase:
    Start:
    31 October, 1998
    Updated:
    05 February, 2009
    Participants:
    0
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