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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joan H. Schiller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000067466

NCT ID:

NCT00004225

Start Date:

January 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516