Gene Therapy in Treating Patients With Ovarian Cancer
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.
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