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

Plain-language summary

This study evaluates a gene therapy (Ad5CMV-p53) in patients with non-small cell lung cancer that cannot be surgically removed. It included adults over 18 in adequate general condition. It was 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

Start date

11/17/1998

Estimated completion

6/15/2007

Countries

United States

Related genes

Locations

• Nashville, United States
• Nashville, United States
• Green Bay, 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 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