Phase
Condition
Digestive System Neoplasms
Lymphoproliferative Disorders
Liver Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Aged ≥ 18 years
Patients with histologically confirmed viral related hepatocellular, SCLC,non-cutaneous/ non-uveal melanoma, ovarian, TNBC, Sarcoma, Bladder and RCC.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Acceptable liver function:
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); for patients withhepatocellular carcinoma only, total bilirubin ≤ 3 mg/dL (i.e. Child-Pugh Scorefor bilirubin is no greater than 2).
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkalinephosphatase (ALP) ≤ 5 x ULN.
- Acceptable renal function:
• Serum creatinine ≤ 1.5 times the ULN, or calculated creatinine clearance ≥ 60mL/min/1.73 m2 for patients with creatinine levels above 1.5 times the institutionalnormal
- Acceptable hematological status:
Absolute Neutrophil Count (ANC) ≥ 1500 cells/mm3
Platelet count ≥ 100,000 plts/mm3 (without transfusion); ≥ 75,000 plts/mm3 forpatients with hepatocellular carcinoma only. For hematologic malignancy patientsblood counts cited above do not apply
Hemoglobin ≥ 9 g/dL
For the hematologic malignancy patients, blood count values cited above do notapply.
Prothrombin time (PT) or International Normalized Ratio (INR) ≤ 1.25 x ULN; forpatients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulationparameter); for patients with hepatocellular carcinoma only, serum albumin > 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologicmalignancy patients, the coagulation and albumin status cited above do not apply
For patients with hepatocellular carcinoma only, Child-Pugh Class A (score 5-6)disease. Score for hepatic encephalopathy must be 1; the score for ascites must be nogreater than 2 and clinically irrelevant; for the determination of the Child-PughClass.
Exclusion
Exclusion Criteria:
Myocardial infarction within the past 6 months, unstable and/or symptomaticarrhythmia, or evidence of ischemia on ECG.
Active, uncontrolled bacterial, viral, or fungal infections requiring systemictherapy.
Pregnant or nursing women.
Known infection with human immunodeficiency virus (HIV).
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, orother conditions) that could compromise protocol objectives in the opinion of theinvestigator and/or the sponsor.
Patients with recent history of hemorrhage and patients predisposed to hemorrhage dueto coagulopathies or structural anomalies.
Patients who require treatment with therapeutic doses of coumadin-type anticoagulants (maximum daily dose of 1mg allowed for port line patency permitted).
Patients with cirrhosis classed as Child-Pugh B or C.
Patients with central nervous system (CNS) metastasis. Intrathecal chemotherapy isallowed for patients who require CNS prophylaxis or therapy.
Patients for whom dexamethasone is contraindicated.
Study Design
Study Description
Connect with a study center
Severance Hospital, Yonsie University Health System
Seoul, Seodaemun-Gu 03722
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 138-736
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 135-710
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 110-744
Korea, Republic ofSite Not Available
Mayo Clinic Arizona
Scottsdale, Arizona 85259
United StatesSite Not Available
Virginia G. Piper Cancer Center
Scottsdale, Arizona 85258
United StatesSite Not Available
Texas Oncology Dallas
Dallas, Texas 75246
United StatesSite Not Available
UT Southwestern Medical Center
Dallas, Texas 75390
United StatesSite Not Available
empty
Fort Worth, Texas
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Uthscsa/Ctrc
San Antonio, Texas 78229
United StatesSite Not Available
Northwest Cancer Specialist
Vancouver, Washington 98684
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.