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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003649
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: February 2002
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: Ad5CMV-p53 gene
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Pilot Trial of Adenovirus p53 in Bronchioloalveolar Cell Lung Carcinoma (BAC) Administered by Bronchoalveolar Lavage

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1998
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003649

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, United States, 37212
United States, Wisconsin
CCOP - Green Bay
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: David P. Carbone, MD, PhD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Publications:
Carbone DP, Adak S, Schiller J, et al.: Adenovirus p53 administered by bronchoalveolar lavage in patients with bronchioalveolar cell lung carcinoma (BAC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-2492, 2003.
Kubba SV, Adak S, Schiller J, et al.: Phase I trial of adenovirus p53 in bronchioalveolar cell lung carcinoma (BAC) administered by bronchioalveolar lavage. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A1904, 2000.

ClinicalTrials.gov Identifier: NCT00003649     History of Changes
Other Study ID Numbers: CDR0000066741, E-6597
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014