GV1001 and Gemcitabine in Sequential Combination to Gemcitabine Monotherapy in Pancreatic Cancer
Advanced Unresectable Pancreatic Cancer
About this trial
This is an interventional treatment trial for Advanced Unresectable Pancreatic Cancer focused on measuring Advanced, Unresesctable, Adenocarcinoma, Pancreatic cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic adenocarcinoma of the pancreas. Adequate hematological parameters: Hemoglobin >/= 9.5 g/dL [SI units, 5.9 mmol/L] WBC >/= 3000/mm3 [SI units, >/= 3 x 109/L] Platelets >/= 100,000/mm3 [SI units, >/= 100 x 109/L] Adequate baseline liver function: Total Bilirubin < 3x ULN and Without liver metastases: AST (SGOT) </= 2.5 x ULN ALT (SGPT) </= 2.5 x ULN With liver metastases: AST (SGOT) </= 5 x ULN ALT (SGPT) </= 5 x ULN Serum creatinine </= 1.5 mg/dL [SI units, 132 µmol/L]. Performance status ECOG 0-1. Male or female 18 - 75 years inclusive. Minimum life expectancy of 3 months. Written informed consent. Exclusion Criteria: Treatment with chemotherapy for pancreatic cancer. Treatment with other investigational drugs within the last 4 weeks prior to inclusion Immune-suppressive therapy <4 weeks prior to inclusion Chronic corticosteroid use except for asthma inhalers / topical use Radiotherapy within 8 weeks of randomisation. Other prior malignancies except for adequately treated non-melanoma skin cancers (BCC, SCC) and carcinoma in situ of the cervix. Known diagnosis of HIV (AIDS), Hepatitis B, C. Known history of or co-existing autoimmune disease. Known CNS metastases. Clinically significant serious disease or organ system disease not currently controlled on present therapy. Pregnancy or lactation. Women of childbearing potential not using reliable and adequate contraceptive methods* Known sensitivity to any components of vaccine, gemcitabine or GM-CSF. Unable for any other reason to comply with the protocol (treatment or assessments). Adequate contraceptive methods are defined as the use of oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy; or women who are practising abstinence; or where the partner is sterile, for example a vasectomy.
Sites / Locations
- University of South Alabama Mitchell Cancer Institute
- Genesis Cancer Center
- Scripps Clinic Torrey Pines
- Desert Hematology Oncology Medical Group, Inc.
- The Center for Hematology-Oncology
- Tampa General Hospital Usf Digestive Disorders Centre
- Palm Beach Cancer Institute
- Portneuf Cancer Center
- Oncology Hematology Associates of Central Illinois, PC
- Hematology Oncology Specialists, Covington
- Berskhire Hematology Oncology PC
- Billings Clinic
- Carolinas Hematology Oncology Associates
- Gabrail Cancer Center
- Toledo Community Hospital Oncology Program
- Southwest Regional Cancer Center
- Mary Crowley Medical Research Center (MCMRC)Texas Oncology-Presbyrerian Hospital of Dallas
- Mary Crowley Medical Research Center, Worth St.
- Oncology Consultants, PA
- St George Hospital, Department of Medical Oncology
- Westmead Hospital, Dept. of Medical Oncology and Palliative Care
- The Townsville Hospital, Townsville Cancer Centre
- Flinders Medical Centre, Medical Oncology - Clinical Trials
- Dept. of Clinical Haematology / Oncology,the Queen Elizabeth Hospital
- Royal Hobart Hospital, Centre for Clinical Research
- Box Hill Hospital, ECRU Oncology
- The Alfred Hospital, Medical Oncology Unit
- Fremantle Hospital, Haemtology Department
- Sir Charles Gairdner Hospital
- Mount Medical Centre, Perth Oncology
- Royal Perth Hospital, Department of Medical Oncology
- Wesley Research Institute Limited
- Erasms University Hospital
- Hospital De Jolimont
- Ghent University Hospital, Digestive Oncology
- Oncology Department, Herlev Hospital
- Odense Universitetshospital, Onkologisk afd. R
- Oncology Department, Århus Hospital
- Centre d'Etudes Cliniques en Oncologie, Centre Paul Papin
- Oncologie Medicale, Clinic Pasteur
- Hepatogastroenterology Dpt, University Hospital Center of Grenoble
- Service de Medicine Interne, CHRU de Lille
- Oncologie Midicale CHR Lorient
- Hôpital de la Roche / Yon <<Les Oudaires>>, Centre Hospitalier Départmentale
- Oncologie Médicale, Centre Cathrine de Siennes
- Service de Cancerologie, Hospital Europeen Georges Pompidou
- Medical Oncology Dpt, Armoricaine Private Hospital of Radiology
- Clinic Saint Vincent
- Oncology Trials Unit, Cork University Hospital
- Cancer Clinical Trials Unit, Beaumont Hospital
- Cancer Research Unit, Mater Misericordlae University Hospital
- Department of Medical Oncology, Amnch
- Oncology Research Team, Mater Private University Hospital
- Medical Oncology, University "Politecnica Delle Marche", Oncologia Medica Universita
- Policlinico Universitario "Mater Domini", Unita Oncologia
- Hospital "Careggi", Medical Oncology
- Azienda Ospedaliera, Arcispedale S. Maria Nuova
- Hospital "G.B. Rossi", Surgical and Gastroenterological Dept. Borgo Roma
- VU University Medical Center
- Department of Oncology, Haukeland University Hospital, G.I. & Urogenital Oncology
- Sorlandet Hospital, Senter for Kreftbehandling
- Ullevål Universitetssykehus, Gastrokirurgisk afd.
- Department of Oncology, University Hospital of Northern-Norway
- Bialstocki Osrodek Onkologiczny, Oddzial Chemioterapii Nowotworow I Chorob Wewnetrznych
- W.S2.Z, Krolewiecka
- Wojewodzki Szpital Specjalistyczny im.Rydgiera, Oddzial Chemioterapii
- Klinika Chemioterapii Uniwersytetu Medycznego w Lodzi, Medical University
- Zaklad Opieki Zdrowotnej MSWiA
- Centrum Onkologii, Wosewodzki Osrodek Onkologii
- Dolnoslaskie Centrum Onkologii, Oddzial Chemioterapii
- Hospital Clinic I Provincial De Barcelona
- Medical Oncology Department, General Hospital of Baza
- Medical Oncology Department, Virgen de Las Nieves Hospital
- Hospital Universitario Gregorio Marañón, Departamento de Oncología
- Clínica Puerta de Hierro, Departamento de Oncología
- Hospital Universitario La Paz, Departamento de Oncología
- H. Monteprincipe
- Fundaciόn Hospital de Alcorcόn, Unidad de Oncología
- HRU Carlos Haya, Medical Oncology Unit
- Oncology Department, Clinic Universitary Hospital
- Digestive Unit, Universitary Hospital Virgen de La Macarena
- Sahlgrenska Hospital, Head Division for Upper GI Surgery
- University Hospital, Department Of surgery and Gasterenterology
- Department of Oncology, Malmö University Hospital
- Karolinska Institute / Hospital Solna, Department of Oncology
- Department of Oncology, Karolinska Universitetssjukhuset
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Gemcitabine
GV1001
Gemcitabine alone treatment.
GV1001 in sequential combination with Gemcitabine