Yumurtalık Kanseri Olan Hastaların Tedavisinde Gen Terapisi

Sade dilde özet

Bu çalışma, yumurtalık kanseri (ovarian cancer) olan hastalarda bir gen terapisini (Ad5CMV-p53 gene) ve laparoskopik cerrahiyi incelemiştir. Çalışmaya, platin ve paklitaksel tedavilerine dirençli, tekrarlayan veya ilerleyen yumurtalık epitel kanseri olan 18 yaş ve üzeri hastalar katılabilmiştir. Çalışma 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

National Cancer Institute (NCI)

Müdahale

Ad5CMV-p53 gene, laparoscopic surgery

Başlangıç

01.09.1998

Ülkeler

United States

İlgili genler

Merkezler

• Houston, United States

Uygunluk kriterleri

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

DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic ovarian epithelial cancer that is platinum- and paclitaxel resistant as defined by: Disease progression while on first-line regimen containing both a platinum drug and paclitaxel OR Tumor progression within 6 months of completion of platinum-based therapy (either as first- or second-line) or paclitaxel-based therapy (either as first- or second-line)
* Refractory or recurrent ovarian epithelial cancer as defined by: Lesions of any diameter
* Nonmeasurable disease (with CA-125 at least 35)
* Ascites and/or pleural effusions allowed
* No borderline or low malignant potential tumors

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: Zubrod 0-2
* Life expectancy: At least 12 weeks
* WBC at least 3,000/mm3
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Bilirubin no greater than 1.5 mg/dL PT/PTT normal
* Creatinine no greater than 1.4 mg/dL
* No active, unresolved upper respiratory infections
* Not HIV positive
* At least 5 years since prior malignancy, except nonmelanomatous skin cancer
* Willing and able to undergo placement of Tenckhoff catheter in the peritoneal cavity for sampling of ascites or peritoneal fluid
* No concurrent serious medical illness
* No untreated gastrointestinal obstruction
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* May have failed an unlimited number of prior chemotherapy regimens
* At least 30 days since prior chemotherapy
* No prior radiotherapy to the pelvis or abdomen
* Eligible for laparoscopy