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

Plain-language summary

This study evaluated Ad5CMV-p53 gene therapy combined with radiation therapy in patients with non-small cell lung cancer. The gene therapy was injected directly into the tumour, either endobronchially or percutaneously, in patients who required palliative radiotherapy to the chest. It was carried out as a Phase 1 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Eastern Cooperative Oncology Group

Intervention

Ad5CMV-p53 gene, radiation therapy

Start date

1/1/2000

Countries

United States

Related genes

Locations

• Nashville, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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