ID

22060

Description

DepoCyt for Active Lymphomatous or Leukemic Meningitis; ODM derived from: https://clinicaltrials.gov/show/NCT00523939

Link

https://clinicaltrials.gov/show/NCT00523939

Keywords

Versions (1)
  1. 5/17/17 5/17/17 -
Uploaded on

May 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoplastic Meningitis NCT00523939

English

Eligibility Neoplastic Meningitis NCT00523939

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cytologically confirmed, or radiographic evidence for lymphomatous or leukemic meningitis. if the csf cytology is negative, patients must have mri/ct brain and clinical findings consistent with neoplastic meningitis.
Description

Meningeal Carcinomatosis | Meningeal Leukemia | Cerebrospinal Fluid Cytological Techniques Negative | MRI brain | CT brain | Signs and Symptoms Consistent with Meningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
UMLS CUI [2]
C0948840
UMLS CUI [3,1]
C0007806
UMLS CUI [3,2]
C0010818
UMLS CUI [3,3]
C1513916
UMLS CUI [4]
C0412675
UMLS CUI [5]
C0412585
UMLS CUI [6,1]
C0037088
UMLS CUI [6,2]
C0332290
UMLS CUI [6,3]
C0220654
karnofsky performance score of 60 or above.
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
age ≥ 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have adequate hematologic, renal and liver function. laboratory
Description

Hematologic function | Renal function | Liver function | Laboratory Results

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1254595
absolute neutrophil count (anc) ≥ 1,500/mm3 or white blood cell count > 3,000/mm3
Description

Absolute neutrophil count | White Blood Cell Count procedure

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0023508
platelet count ≥ 100, 000/mm3
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
bun and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal
Description

Blood urea nitrogen measurement | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0005845
UMLS CUI [2]
C0201976
total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal
Description

Serum total bilirubin measurement | Bilirubin, direct measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201916
sgot and sgpt ≤ 3.0 times upper limit of laboratory normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal
Description

Serum alkaline phosphatase - liver

Data type

boolean

Alias
UMLS CUI [1]
C0857886
no uncontrolled infection other than human immunodeficiency virus that is being treated with anti-retroviral therapy
Description

Communicable Disease Uncontrolled | Antiretroviral therapy HIV Infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C1963724
UMLS CUI [2,2]
C0019693
patients who have had prior cns radiation, prior intrathecal methotrexate, and prior cns prophylaxis with intrathecal or intravenous cytarabine or methotrexate are eligible
Description

Therapeutic radiology procedure Central Nervous System | Methotrexate Intrathecal | Central Nervous System Prophylaxis | Cytarabine Intrathecal | Cytarabine Intravenous | Methotrexate

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C3714787
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0677897
UMLS CUI [3]
C1516386
UMLS CUI [4,1]
C0010711
UMLS CUI [4,2]
C0677897
UMLS CUI [5,1]
C0010711
UMLS CUI [5,2]
C1522726
UMLS CUI [6]
C0025677
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
experimental/investigational chemotherapy, immunotherapy, or biologic therapy within four weeks prior to study
Description

Chemotherapy Investigational | Immunotherapy Investigational | Biological treatment Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C0021083
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C1517586
concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine, or high dose thiotepa (they cross the blood brain barrier at high levels)
Description

Systemic Chemotherapy | Methotrexate High dose | Cytarabine High dose | Thiotepa High dose | Blood - brain barrier Involved

Data type

boolean

Alias
UMLS CUI [1]
C1883256
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0444956
UMLS CUI [3,1]
C0010711
UMLS CUI [3,2]
C0444956
UMLS CUI [4,1]
C0039871
UMLS CUI [4,2]
C0444956
UMLS CUI [5,1]
C0005854
UMLS CUI [5,2]
C1314939
patients receiving whole brain radiotherapy or craniospinal irradiation
Description

Whole brain radiotherapy | Craniospinal Irradiation

Data type

boolean

Alias
UMLS CUI [1]
C1520143
UMLS CUI [2]
C3494227
previous (less than 2 years from diagnosis) or concurrent malignancies at other sites with the exception of fully treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer not requiring ongoing chemotherapy
Description

Malignant Neoplasm Site | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Prostate carcinoma Chemotherapy Unnecessary

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0851140
UMLS CUI [2,2]
C1522326
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0600139
UMLS CUI [5,2]
C0392920
UMLS CUI [5,3]
C1710572
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
known active meningeal infection
Description

meninges; infection

Data type

boolean

Alias
UMLS CUI [1]
C1400607
evidence of obstructive hydrocephalus requiring neurosurgical intervention
Description

Obstructive Hydrocephalus Requirement Neurosurgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0549423
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0524850
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Similar models

Eligibility Neoplastic Meningitis NCT00523939

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Meningeal Carcinomatosis | Meningeal Leukemia | Cerebrospinal Fluid Cytological Techniques Negative | MRI brain | CT brain | Signs and Symptoms Consistent with Meningeal Carcinomatosis
Item
cytologically confirmed, or radiographic evidence for lymphomatous or leukemic meningitis. if the csf cytology is negative, patients must have mri/ct brain and clinical findings consistent with neoplastic meningitis.
boolean
C0220654 (UMLS CUI [1])
C0948840 (UMLS CUI [2])
C0007806 (UMLS CUI [3,1])
C0010818 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
C0412675 (UMLS CUI [4])
C0412585 (UMLS CUI [5])
C0037088 (UMLS CUI [6,1])
C0332290 (UMLS CUI [6,2])
C0220654 (UMLS CUI [6,3])
Karnofsky Performance Status
Item
karnofsky performance score of 60 or above.
boolean
C0206065 (UMLS CUI [1])
Age
Item
age ≥ 18 years.
boolean
C0001779 (UMLS CUI [1])
Hematologic function | Renal function | Liver function | Laboratory Results
Item
patients must have adequate hematologic, renal and liver function. laboratory
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C1254595 (UMLS CUI [4])
Absolute neutrophil count | White Blood Cell Count procedure
Item
absolute neutrophil count (anc) ≥ 1,500/mm3 or white blood cell count > 3,000/mm3
boolean
C0948762 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
Platelet Count measurement
Item
platelet count ≥ 100, 000/mm3
boolean
C0032181 (UMLS CUI [1])
Blood urea nitrogen measurement | Creatinine measurement, serum
Item
bun and serum creatinine must be ≤ 1.5 times upper limit of laboratory normal
boolean
C0005845 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Serum total bilirubin measurement | Bilirubin, direct measurement
Item
total and direct serum bilirubin must be ≤ 1.5 times upper limit of laboratory normal
boolean
C1278039 (UMLS CUI [1])
C0201916 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
sgot and sgpt ≤ 3.0 times upper limit of laboratory normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Serum alkaline phosphatase - liver
Item
alkaline phosphatase derived from liver ≤ 2.0 times upper limit of laboratory normal
boolean
C0857886 (UMLS CUI [1])
Communicable Disease Uncontrolled | Antiretroviral therapy HIV Infection
Item
no uncontrolled infection other than human immunodeficiency virus that is being treated with anti-retroviral therapy
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1963724 (UMLS CUI [2,1])
C0019693 (UMLS CUI [2,2])
Therapeutic radiology procedure Central Nervous System | Methotrexate Intrathecal | Central Nervous System Prophylaxis | Cytarabine Intrathecal | Cytarabine Intravenous | Methotrexate
Item
patients who have had prior cns radiation, prior intrathecal methotrexate, and prior cns prophylaxis with intrathecal or intravenous cytarabine or methotrexate are eligible
boolean
C1522449 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2,1])
C0677897 (UMLS CUI [2,2])
C1516386 (UMLS CUI [3])
C0010711 (UMLS CUI [4,1])
C0677897 (UMLS CUI [4,2])
C0010711 (UMLS CUI [5,1])
C1522726 (UMLS CUI [5,2])
C0025677 (UMLS CUI [6])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Investigational | Immunotherapy Investigational | Biological treatment Investigational
Item
experimental/investigational chemotherapy, immunotherapy, or biologic therapy within four weeks prior to study
boolean
C0392920 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0021083 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
Systemic Chemotherapy | Methotrexate High dose | Cytarabine High dose | Thiotepa High dose | Blood - brain barrier Involved
Item
concurrent systemic chemotherapy with high dose methotrexate, high dose cytarabine, or high dose thiotepa (they cross the blood brain barrier at high levels)
boolean
C1883256 (UMLS CUI [1])
C0025677 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0010711 (UMLS CUI [3,1])
C0444956 (UMLS CUI [3,2])
C0039871 (UMLS CUI [4,1])
C0444956 (UMLS CUI [4,2])
C0005854 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
Whole brain radiotherapy | Craniospinal Irradiation
Item
patients receiving whole brain radiotherapy or craniospinal irradiation
boolean
C1520143 (UMLS CUI [1])
C3494227 (UMLS CUI [2])
Malignant Neoplasm Site | Carcinoma in situ of uterine cervix Treated | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Prostate carcinoma Chemotherapy Unnecessary
Item
previous (less than 2 years from diagnosis) or concurrent malignancies at other sites with the exception of fully treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin, or prostate cancer not requiring ongoing chemotherapy
boolean
C0006826 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0851140 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0600139 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C1710572 (UMLS CUI [5,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
meninges; infection
Item
known active meningeal infection
boolean
C1400607 (UMLS CUI [1])
Obstructive Hydrocephalus Requirement Neurosurgical Procedures
Item
evidence of obstructive hydrocephalus requiring neurosurgical intervention
boolean
C0549423 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0524850 (UMLS CUI [1,3])
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