Age
Item
1. male or female patients 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
Merkel cell carcinoma Inoperable TNM clinical staging | Merkel cell carcinoma of unknown primary origin
Item
2. patients must have histologically confirmed merkel cell carcinoma (mcc) that is inoperable stage iii (iiib) or stage iv, as defined by the 2010 ajcc staging criteria for mcc(2). patients with stage iiib mcc must have been evaluated by a surgical oncologist who has documented that their disease is surgically unresectable. mcc of unknown primary is allowed.
boolean
C0007129 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007129 (UMLS CUI [2,1])
C0220647 (UMLS CUI [2,2])
Cytotoxic Chemotherapy Quantity Merkel cell carcinoma | Immunotherapy Quantity Merkel cell carcinoma
Item
3. up to two prior cytotoxic chemotherapies and/or novel immunotherapy treatments for mcc are allowed.
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007129 (UMLS CUI [1,3])
C0021083 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0007129 (UMLS CUI [2,3])
ECOG performance status
Item
4. ecog performance status of 0-2.
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
5. voluntary written informed consent must be given before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
boolean
C0021430 (UMLS CUI [1])
Major surgery
Item
1. major surgery within 30 days before study entry.
boolean
C0679637 (UMLS CUI [1])
Laboratory Results
Item
2. any of the following clinical laboratory values at the time of enrollment:
boolean
C1254595 (UMLS CUI [1])
Absolute neutrophil count
Item
1. absolute neutrophil count (anc) < 1,000 cells/mm3,
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
2. platelets < 50,000 x 109/l,
boolean
C0032181 (UMLS CUI [1])
Liver Dysfunction | Elevated liver enzymes | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated gamma-glutamyltransferase | Elevation Relationship Tumor infiltration
Item
3. liver function abnormalities as indicated by ongoing hepatic enzyme elevation (e.g. ast, alt, ggt) > 2x the uln. elevation related to direct tumor infiltration is allowed.
boolean
C0086565 (UMLS CUI [1])
C0235996 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C1864581 (UMLS CUI [5])
C0702240 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C4060690 (UMLS CUI [6,3])
Renal Insufficiency | Serum creatinine raised
Item
4. renal insufficiency as indicated by a creatinine level > 2 x the uln.
boolean
C1565489 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Cardiac Arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities | Electrocardiogram abnormal
Item
5. myocardial infarction within 6 months prior to enrollment or new york hospital association (nyha) class iii or iv heart failure, uncontrolled angina, severe uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or significant conduction system abnormalities in the opinion of the investigator. prior to study entry any known abnormality on electrocardiogram (ecg) must be determined and documented by the investigator to be not clinically significant to the patient participation in this study.
boolean
C0027051 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])
C0002962 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0003811 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0022116 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0151236 (UMLS CUI [6])
C0522055 (UMLS CUI [7])
Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk | Medical condition Interferes with Study Subject Participation Status | Mental disorders Interfere with Study Subject Participation Status
Item
6. any condition, including laboratory abnormalities, that in the opinion of the investigator places the patient at unacceptable risk if he/she were to participate in the study. this includes, but is not limited, to serious medical conditions or psychiatric illness likely to interfere with participation in this clinical study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
7. female patients who are pregnant or breastfeeding. female patients of childbearing potential must have a negative pregnancy test and agree to use adequate contraception for the duration of the trial.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
Cancer Other
Item
8. patients with other malignancies are not eligible. however, given the frequent coexistence of mcc with other malignancies, the following exceptions are allowed:
boolean
C1707251 (UMLS CUI [1])
Exception Solid Neoplasm Free Duration
Item
1. if they have been continuously disease-free for any solid tumor malignancy >3 years prior to the time of enrollment,
boolean
C1705847 (UMLS CUI [1,1])
C0280100 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,4])
Exception Basal cell carcinoma | Exception Squamous cell carcinoma
Item
2. patients with basal cell carcinoma or squamous cell carcinoma
boolean
C1705847 (UMLS CUI [1,1])
C0007117 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007137 (UMLS CUI [2,2])
Exception Carcinoma in Situ | Breast Carcinoma | Melanoma | Squamous cell carcinoma of skin | Cervix carcinoma
Item
3. patients with prior history of in situ cancer (e.g. breast, melanoma, squamous cells carcinoma of the skin, cervical),
boolean
C1705847 (UMLS CUI [1,1])
C0007099 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2])
C0025202 (UMLS CUI [3])
C0553723 (UMLS CUI [4])
C0302592 (UMLS CUI [5])
Exception Prostate carcinoma Without Systemic therapy | Exception Hormone Therapy | PSA Undetectable | PSA measurement
Item
4. patients with prior history of prostate cancer that is not under active systemic treatment except hormonal therapy, but with undetectable psa (<0.2ng/ml),
boolean
C1705847 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C1515119 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0138741 (UMLS CUI [3,1])
C3827727 (UMLS CUI [3,2])
C0201544 (UMLS CUI [4])
Eligibility | Chronic Lymphocytic Leukemia | Lymphocytosis Isolated Rai Staging System | Requirement Absent Systemic therapy | B-Symptoms | Richter's syndrome | Lymphocyte Doubling Time | Lymphadenopathy Absent | Hepatosplenomegaly Absent
Item
5. patients with chronic lymphocytic leukemia are eligible if they have isolated lymphocytosis (rai stage o) on the condition that they do not require systemic treatment for their disease ["b" symptoms, richter's transformation, lymphocyte doubling time (<6 months) and they do not have lymphadenopathy of hepatosplenomegaly].
boolean
C1548635 (UMLS CUI [1])
C0023434 (UMLS CUI [2])
C0024282 (UMLS CUI [3,1])
C0205409 (UMLS CUI [3,2])
C1514715 (UMLS CUI [3,3])
C1514873 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1515119 (UMLS CUI [4,3])
C1706867 (UMLS CUI [5])
C0349631 (UMLS CUI [6])
C0024264 (UMLS CUI [7,1])
C2986483 (UMLS CUI [7,2])
C0497156 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0019214 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
Eligibility | Lymphoma Type Any | Hairy Cell Leukemia | Systemic therapy Absent Hematological Disease | In complete remission PET/CT scan | In complete remission Bone marrow biopsy
Item
6. patients with lymphoma of any type or hairy cell leukemia are eligible on the condition that they do not receive active systemic treatment for their hematologic disease and are in complete remission as evidenced by pet/ct scans and bone marrow biopsies for at least 3 months.
boolean
C1548635 (UMLS CUI [1])
C0024299 (UMLS CUI [2,1])
C0332307 (UMLS CUI [2,2])
C1552551 (UMLS CUI [2,3])
C0023443 (UMLS CUI [3])
C1515119 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0018939 (UMLS CUI [4,3])
C0677874 (UMLS CUI [5,1])
C1699633 (UMLS CUI [5,2])
C0677874 (UMLS CUI [6,1])
C0005954 (UMLS CUI [6,2])
Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE | Investigational New Drugs
Item
9. patients on immunosuppressants, systemic corticosteroids or any other investigational product.
boolean
C0021081 (UMLS CUI [1])
C3653708 (UMLS CUI [2])
C0013230 (UMLS CUI [3])