Gene Therapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

July 3, 2010 updated by: Eastern Cooperative Oncology Group

Phase I Pilot Trial of Adenovirus p53 and Radiotherapy on Nonsmall Cell Lung Cancer

RATIONALE: Inserting the gene for p53 into a person's cancer cells may improve the body's ability to fight cancer. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gene therapy plus radiation therapy in treating patients who have non-small cell lung cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the feasibility and tolerability of adenovirus p53 gene therapy and radiotherapy in patients with non-small cell lung cancer with or without prior radiotherapy to the indicator lesion(s).
  • Determine p53 and p21 expression and induction of apoptosis and necrosis in patients treated with this regimen.
  • Assess any vector incorporation, antitumor response, local control, viral dissemination, and development of adenovirus antibodies in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by prior radiotherapy to the indicator lesion(s) (yes vs no).

Adenovirus p53 is injected directly into an endobronchial lesion via bronchoscopy or into locoregional tumors via multiple percutaneous punctures under fluoroscopic, ultrasonic, or CT scan guidance on days 1, 3, and 8. Patients undergo radiotherapy beginning on day 2 and continuing for a total of 10 days.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 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 at Vanderbilt Medical Center

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically proven non-small cell lung cancer with at least 1 lesion accessible for endobronchial or percutaneous injection
  • Measurable or evaluable disease
  • Must have a requirement for palliative radiotherapy to the thorax
  • Clinically stable enough to undergo 3 adenovirus injections

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0 or 1

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Platelet count greater than 100,000/mm^3

Hepatic:

  • PT and PTT normal

Renal:

  • Not specified

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • No active systemic viral, bacterial, or fungal infection requiring treatment
  • No concurrent illness requiring hospitalization or IV medications or psychologic, familial, sociologic, geographic, or other concurrent condition that would preclude adequate follow up and compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior adenoviral gene therapy
  • Any number of any type of other prior biologic therapy allowed

Chemotherapy:

  • Any number of any type of prior chemotherapy allowed
  • At least 2 weeks since prior systemic cancer therapy and no worse than grade 2 toxicity in any organ

Endocrine therapy:

  • Any number of any type of prior endocrine therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy greater than 50 Gy if prior and concurrent radiation fields include the spinal cord
  • No prior radiotherapy in fraction sizes greater than 2 Gy with the spinal cord in the concurrent radiation field

Surgery:

  • At least 4 weeks since surgical resection of lung tissue
  • At least 2 weeks since any other prior surgery requiring general anesthesia and recovered

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: Joan H. Schiller, MD, University of Wisconsin, Madison

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

January 1, 2000

Study Registration Dates

First Submitted

January 28, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 3, 2010

Last Verified

April 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067466
  • ECOG-8597

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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