Küçük Hücreli Dışı Akciğer Kanseri Hastalarında Gen Terapisi ile Birlikte Radyoterapi

Sade dilde özet

Bu çalışma, küçük hücreli dışı akciğer kanseri olan hastalarda Ad5CMV-p53 gen terapisinin radyoterapi ile birlikte kullanımını değerlendirmiştir. Gen terapisi, bronkoskopi ya da deri yoluyla doğrudan tümöre enjekte edilmiştir; çalışmaya göğüs bölgesine palyatif radyoterapi gereken hastalar alınmıştır. Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Eastern Cooperative Oncology Group

Müdahale

Ad5CMV-p53 gene, radiation therapy

Başlangıç

01.01.2000

Ülkeler

United States

İlgili genler

Merkezler

• Nashville, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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