Yükleniyor... / Loading...
Vaccine Therapy With or Without Cyclophosphamide in Treating Patients Undergoing Chemotherapy and Radiation Therapy for Stage I or Stage II Pancreatic Cancer That Can Be Removed by Surgery
Bu çalışma, cerrahi ile çıkarılabilen Evre I veya II pankreas kanseri (pancreatic cancer) olan hastalarda GVAX pankreas kanseri aşısını, siklofosfamid (cyclophosphamide) ile birlikte veya tek başına değerlendirmiştir. Çalışmaya, yeni tanı almış, ameliyatla çıkarılabilir pankreas adenokarsinomu olan ve uygun genel sağlık durumundaki hastalar katılabilmiştir. Johns Hopkins Sidney Kimmel Comprehensive Cancer Center tarafından yürütülen çalışma Faz 2 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: * Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas * Stage I or II disease * Surgically resectable disease (R0 or R1) by spiral CT scan * No distant metastases * A clear fat plane is present around the celiac and superior mesenteric arteries * Patent superior mesenteric and portal veins * Candidate for a pancreaticoduodenectomy PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Hemoglobin ≥ 9 g/dL * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Serum creatinine ≤ 2 mg/dL * AST and ALT ≤ 2 times upper limit of normal (ULN) * Amylase ≤ 2 times ULN * Alkaline phosphatase ≤ 5 times ULN * Hyperbilirubinemia secondary to tumor-associated extrahepatic biliary obstruction allowed * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 4 weeks after the completion of study treatment * No history of autoimmune disease, including systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis * No uncontrolled medical problems * No active infections * No other cancer within the past 5 years except for superficial bladder cancer, nonmelanoma skin cancer, or low-grade prostate cancer not requiring therapy PRIOR CONCURRENT THERAPY: * More than 28 days since prior anticancer therapy * No prior cancer immunotherapy, including the same pancreatic cancer vaccine used in this study * More than 28 days since prior systemic steroid therapy or immunosuppressive therapy * No systemic steroid therapy or immunosuppressive therapy during and within 28 days after vaccine administration * No other concurrent immunotherapy, chemotherapy, radiotherapy, gene therapy, biologic therapy, or investigational therapy for the treatment of pancreatic cancer