ID

37276

Beskrivning

Study of Neukoplast (NK-92) Infusions in Patients With Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC); ODM derived from: https://clinicaltrials.gov/show/NCT02465957

Länk

https://clinicaltrials.gov/show/NCT02465957

Nyckelord

Versioner (1)
  1. 2019-07-12 2019-07-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Stage IIIB Merkel Cell Carcinoma NCT02465957

Engelsk

Eligibility Stage IIIB Merkel Cell Carcinoma NCT02465957

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. male or female patients 18 years of age or older.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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.
Beskrivning

Merkel cell carcinoma Inoperable TNM clinical staging | Merkel cell carcinoma of unknown primary origin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007129
UMLS CUI [1,2]
C0205187
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C0007129
UMLS CUI [2,2]
C0220647
3. up to two prior cytotoxic chemotherapies and/or novel immunotherapy treatments for mcc are allowed.
Beskrivning

Cytotoxic Chemotherapy Quantity Merkel cell carcinoma | Immunotherapy Quantity Merkel cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007129
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0007129
4. ecog performance status of 0-2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. major surgery within 30 days before study entry.
Beskrivning

Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
2. any of the following clinical laboratory values at the time of enrollment:
Beskrivning

Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1]
C1254595
1. absolute neutrophil count (anc) < 1,000 cells/mm3,
Beskrivning

Absolute neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
2. platelets < 50,000 x 109/l,
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
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.
Beskrivning

Liver Dysfunction | Elevated liver enzymes | Aspartate aminotransferase increased | Alanine aminotransferase increased | Elevated gamma-glutamyltransferase | Elevation Relationship Tumor infiltration

Datatyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0235996
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C1864581
UMLS CUI [6,1]
C0702240
UMLS CUI [6,2]
C0439849
UMLS CUI [6,3]
C4060690
4. renal insufficiency as indicated by a creatinine level > 2 x the uln.
Beskrivning

Renal Insufficiency | Serum creatinine raised

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0700225
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.
Beskrivning

Myocardial Infarction | Heart failure New York Heart Association Classification | Angina Pectoris Uncontrolled | Cardiac Arrhythmia Severe Uncontrolled | Ischemia Electrocardiography | Conduction system abnormalities | Electrocardiogram abnormal

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1275491
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0022116
UMLS CUI [5,2]
C1623258
UMLS CUI [6]
C0151236
UMLS CUI [7]
C0522055
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444641
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
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.
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0427780
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0700589
8. patients with other malignancies are not eligible. however, given the frequent coexistence of mcc with other malignancies, the following exceptions are allowed:
Beskrivning

Cancer Other

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
1. if they have been continuously disease-free for any solid tumor malignancy >3 years prior to the time of enrollment,
Beskrivning

Exception Solid Neoplasm Free Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0280100
UMLS CUI [1,3]
C0332296
UMLS CUI [1,4]
C0449238
2. patients with basal cell carcinoma or squamous cell carcinoma
Beskrivning

Exception Basal cell carcinoma | Exception Squamous cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007117
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007137
3. patients with prior history of in situ cancer (e.g. breast, melanoma, squamous cells carcinoma of the skin, cervical),
Beskrivning

Exception Carcinoma in Situ | Breast Carcinoma | Melanoma | Squamous cell carcinoma of skin | Cervix carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0007099
UMLS CUI [2]
C0678222
UMLS CUI [3]
C0025202
UMLS CUI [4]
C0553723
UMLS CUI [5]
C0302592
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),
Beskrivning

Exception Prostate carcinoma Without Systemic therapy | Exception Hormone Therapy | PSA Undetectable | PSA measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705847
UMLS CUI [1,2]
C0600139
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C1515119
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0279025
UMLS CUI [3,1]
C0138741
UMLS CUI [3,2]
C3827727
UMLS CUI [4]
C0201544
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].
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C1548635
UMLS CUI [2]
C0023434
UMLS CUI [3,1]
C0024282
UMLS CUI [3,2]
C0205409
UMLS CUI [3,3]
C1514715
UMLS CUI [4,1]
C1514873
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C1515119
UMLS CUI [5]
C1706867
UMLS CUI [6]
C0349631
UMLS CUI [7,1]
C0024264
UMLS CUI [7,2]
C2986483
UMLS CUI [8,1]
C0497156
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C0019214
UMLS CUI [9,2]
C0332197
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.
Beskrivning

Eligibility | Lymphoma Type Any | Hairy Cell Leukemia | Systemic therapy Absent Hematological Disease | In complete remission PET/CT scan | In complete remission Bone marrow biopsy

Datatyp

boolean

Alias
UMLS CUI [1]
C1548635
UMLS CUI [2,1]
C0024299
UMLS CUI [2,2]
C0332307
UMLS CUI [2,3]
C1552551
UMLS CUI [3]
C0023443
UMLS CUI [4,1]
C1515119
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0018939
UMLS CUI [5,1]
C0677874
UMLS CUI [5,2]
C1699633
UMLS CUI [6,1]
C0677874
UMLS CUI [6,2]
C0005954
9. patients on immunosuppressants, systemic corticosteroids or any other investigational product.
Beskrivning

Immunosuppressive Agents | CORTICOSTEROIDS FOR SYSTEMIC USE | Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C3653708
UMLS CUI [3]
C0013230
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Similar models

Eligibility Stage IIIB Merkel Cell Carcinoma NCT02465957

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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