ID

23157

Description

CDDO to Treat Solid Tumors and Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00322140

Link

https://clinicaltrials.gov/show/NCT00322140

Keywords

Versions (1)
  1. 6/26/17 6/26/17 -
Uploaded on

June 26, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Solid Tumors NCT00322140

English

Eligibility Solid Tumors NCT00322140

1 forms  
Criteria
Description

Criteria

patients must have histologically confirmed (by nih pathology department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which there is not therapy with survival benefit and standard curative or palliative measures do not exist.
Description

Malignant solid tumour | Malignant lymphoma, metastatic | Lymphoma unresectable | Therapeutic procedure Survival aspects Lacking | Curative treatment Standard Lacking | Palliative procedure Standard Lacking

Data type

boolean

Alias
UMLS CUI [1]
C1698088
UMLS CUI [2]
C1266190
UMLS CUI [3,1]
C0024299
UMLS CUI [3,2]
C1519810
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0220921
UMLS CUI [4,3]
C0332268
UMLS CUI [5,1]
C1273390
UMLS CUI [5,2]
C1442989
UMLS CUI [5,3]
C0332268
UMLS CUI [6,1]
C1285158
UMLS CUI [6,2]
C1442989
UMLS CUI [6,3]
C0332268
patients must have measurable or evaluable disease.
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
patients must have recovered less than or equal to grade 1 toxicity levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy. they must not have had chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin c, 8 weeks for ucn-01). patients must be at least 1 month since any prior radiation or major surgery. patients must be greater than or equal to 2 weeks since any prior participation in a phase zero study. patients on bisphosphonates for any cancer or on androgen deprivation therapy for prostate cancer, however, will not need to discontinue this therapy in order to be eligible.
Description

Toxicity CTCAE Grades | Toxicity Due to Chemotherapy | Toxicity Due to Biological treatment | Patient recovered | Nitrosourea Compounds | Mitomycin | UCN 01 | Therapeutic radiology procedure | major surgery | Participation Phase 0 Trial | Diphosphonates | Malignant Neoplasms | Antiandrogen therapy Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0392920
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1531518
UMLS CUI [4]
C1115804
UMLS CUI [5]
C0028210
UMLS CUI [6]
C0002475
UMLS CUI [7]
C0950721
UMLS CUI [8]
C1522449
UMLS CUI [9]
C0679637
UMLS CUI [10,1]
C0679823
UMLS CUI [10,2]
C1882358
UMLS CUI [11]
C0012544
UMLS CUI [12]
C0006826
UMLS CUI [13,1]
C0279492
UMLS CUI [13,2]
C0600139
age greater than or equal to 18 years.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60%, see appendix a).
Description

ECOG performance status | Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
life expectancy of greater than 3 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
patients must have normal or adequate organ and marrow function as defined below:
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
hb greater than or equal to 10 g/dl
Description

Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0518015
absolute neutrophil count greater than or equal to 1,500/ l
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelets greater than or equal to 100,000/ l
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin less than or equal to 1.5 normal institutional limits
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
ast (sgot)/alt (sgpt) less than or equal to 2.5 x institutional upper limit of normal
Description

Alanine aminotransferase measurement | Aspartate aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0201836
UMLS CUI [2]
C0201899
creatinine clearance less than 1 x upper limit of normal
Description

Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
creatinine clearance greater than or equal to 60 ml/min/1.73 m(2) for patients with creatinine levels above institutional normal.
Description

Creatinine clearance measurement | Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0700225
the effects of cddo on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation and for 2 months after discontinuation of the study. women of child bearing potential must have a negative pregnancy test in order to be eligible. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cddo, breastfeeding should be discontinued if the mother is treated with cddo.
Description

CDDO | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Pregnancy test negative | Risk Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0762434
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0036899
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0427780
UMLS CUI [8,1]
C0035647
UMLS CUI [8,2]
C0877248
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients receiving any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for at least 6 months after treatment of the brain metastases without steroids or anti-seizure medications. these patients may be enrolled at the discretion of the principal investigator.
Description

Metastatic malignant neoplasm to brain | Therapeutic procedure Metastatic malignant neoplasm to brain | Steroids | Anticonvulsants | Brain Neoplasm Metastasis Stable

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0220650
UMLS CUI [3]
C0038317
UMLS CUI [4]
C0003286
UMLS CUI [5,1]
C0006104
UMLS CUI [5,2]
C0027627
UMLS CUI [5,3]
C0205360
history of allergic reactions attributed to other synthetic triperinoids or compounds of similar chemical or biologic composition to cddo, such as derivative compounds 1-[2-cyano-3-,12- dioxooleana -1,9-dien-28-oyl] imidazole (cddo-im), and c-28 methyl ester of 2-cyano-3,12-dioxoolen-1,9-dien-28-oic acid (cddo-me).
Description

Allergic Reaction Triterpenoid Compound | Allergic Reaction CDDO Chemical composition Similar | Allergic Reaction CDDO-Im | Allergic Reaction CDDO-Me

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1519655
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0762434
UMLS CUI [2,3]
C0243176
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1175500
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1100924
patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to: active or uncontrolled infection, immune deficiencies or confirmed diagnosis of hiv infection, hepatitis b, hepatitis c, or uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past six months, uncontrolled cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Illness compromises Study Subject Participation Status | Communicable Disease | Communicable Disease Uncontrolled | Immunologic Deficiency Syndromes | HIV Infection | Hepatitis B | Hepatitis C | Diabetic - poor control | Uncontrolled hypertension | Symptomatic congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C2348568
UMLS CUI [2]
C0009450
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0021051
UMLS CUI [5]
C0019693
UMLS CUI [6]
C0019163
UMLS CUI [7]
C0019196
UMLS CUI [8]
C0421258
UMLS CUI [9]
C1868885
UMLS CUI [10]
C0742758
UMLS CUI [11]
C0002965
UMLS CUI [12]
C0027051
UMLS CUI [13,1]
C0003811
UMLS CUI [13,2]
C0205318
UMLS CUI [14,1]
C0004936
UMLS CUI [14,2]
C0525058
UMLS CUI [14,3]
C0439801
UMLS CUI [15,1]
C0748872
UMLS CUI [15,2]
C0525058
UMLS CUI [15,3]
C0439801
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Similar models

Eligibility Solid Tumors NCT00322140

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Malignant solid tumour | Malignant lymphoma, metastatic | Lymphoma unresectable | Therapeutic procedure Survival aspects Lacking | Curative treatment Standard Lacking | Palliative procedure Standard Lacking
Item
patients must have histologically confirmed (by nih pathology department) solid tumor malignancy or lymphoma that is metastatic or unresectable and for which there is not therapy with survival benefit and standard curative or palliative measures do not exist.
boolean
C1698088 (UMLS CUI [1])
C1266190 (UMLS CUI [2])
C0024299 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C0087111 (UMLS CUI [4,1])
C0220921 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])
C1273390 (UMLS CUI [5,1])
C1442989 (UMLS CUI [5,2])
C0332268 (UMLS CUI [5,3])
C1285158 (UMLS CUI [6,1])
C1442989 (UMLS CUI [6,2])
C0332268 (UMLS CUI [6,3])
Measurable Disease | Evaluable Disease
Item
patients must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Toxicity CTCAE Grades | Toxicity Due to Chemotherapy | Toxicity Due to Biological treatment | Patient recovered | Nitrosourea Compounds | Mitomycin | UCN 01 | Therapeutic radiology procedure | major surgery | Participation Phase 0 Trial | Diphosphonates | Malignant Neoplasms | Antiandrogen therapy Prostate carcinoma
Item
patients must have recovered less than or equal to grade 1 toxicity levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy. they must not have had chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin c, 8 weeks for ucn-01). patients must be at least 1 month since any prior radiation or major surgery. patients must be greater than or equal to 2 weeks since any prior participation in a phase zero study. patients on bisphosphonates for any cancer or on androgen deprivation therapy for prostate cancer, however, will not need to discontinue this therapy in order to be eligible.
boolean
C0600688 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1531518 (UMLS CUI [3,3])
C1115804 (UMLS CUI [4])
C0028210 (UMLS CUI [5])
C0002475 (UMLS CUI [6])
C0950721 (UMLS CUI [7])
C1522449 (UMLS CUI [8])
C0679637 (UMLS CUI [9])
C0679823 (UMLS CUI [10,1])
C1882358 (UMLS CUI [10,2])
C0012544 (UMLS CUI [11])
C0006826 (UMLS CUI [12])
C0279492 (UMLS CUI [13,1])
C0600139 (UMLS CUI [13,2])
Age
Item
age greater than or equal to 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60%, see appendix a).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have normal or adequate organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Hemoglobin measurement
Item
hb greater than or equal to 10 g/dl
boolean
C0518015 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count greater than or equal to 1,500/ l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets greater than or equal to 100,000/ l
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin less than or equal to 1.5 normal institutional limits
boolean
C1278039 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
ast (sgot)/alt (sgpt) less than or equal to 2.5 x institutional upper limit of normal
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Creatinine clearance measurement
Item
creatinine clearance less than 1 x upper limit of normal
boolean
C0373595 (UMLS CUI [1])
Creatinine clearance measurement | Serum creatinine raised
Item
creatinine clearance greater than or equal to 60 ml/min/1.73 m(2) for patients with creatinine levels above institutional normal.
boolean
C0373595 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
CDDO | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Pregnancy test negative | Risk Adverse event
Item
the effects of cddo on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation and for 2 months after discontinuation of the study. women of child bearing potential must have a negative pregnancy test in order to be eligible. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cddo, breastfeeding should be discontinued if the mother is treated with cddo.
boolean
C0762434 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0079399 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
C3831118 (UMLS CUI [7,1])
C0427780 (UMLS CUI [7,2])
C0035647 (UMLS CUI [8,1])
C0877248 (UMLS CUI [8,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
patients receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Therapeutic procedure Metastatic malignant neoplasm to brain | Steroids | Anticonvulsants | Brain Neoplasm Metastasis Stable
Item
patients with known brain metastases are excluded from this clinical trial, with the exception of patients whose brain metastatic disease status has remained stable for at least 6 months after treatment of the brain metastases without steroids or anti-seizure medications. these patients may be enrolled at the discretion of the principal investigator.
boolean
C0220650 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C0038317 (UMLS CUI [3])
C0003286 (UMLS CUI [4])
C0006104 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
Allergic Reaction Triterpenoid Compound | Allergic Reaction CDDO Chemical composition Similar | Allergic Reaction CDDO-Im | Allergic Reaction CDDO-Me
Item
history of allergic reactions attributed to other synthetic triperinoids or compounds of similar chemical or biologic composition to cddo, such as derivative compounds 1-[2-cyano-3-,12- dioxooleana -1,9-dien-28-oyl] imidazole (cddo-im), and c-28 methyl ester of 2-cyano-3,12-dioxoolen-1,9-dien-28-oic acid (cddo-me).
boolean
C1527304 (UMLS CUI [1,1])
C1519655 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C0762434 (UMLS CUI [2,2])
C0243176 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C1175500 (UMLS CUI [3,2])
C1527304 (UMLS CUI [4,1])
C1100924 (UMLS CUI [4,2])
Illness compromises Study Subject Participation Status | Communicable Disease | Communicable Disease Uncontrolled | Immunologic Deficiency Syndromes | HIV Infection | Hepatitis B | Hepatitis C | Diabetic - poor control | Uncontrolled hypertension | Symptomatic congestive heart failure | Angina, Unstable | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
patients with clinically significant illnesses which could compromise participation in the study, including, but not limited to: active or uncontrolled infection, immune deficiencies or confirmed diagnosis of hiv infection, hepatitis b, hepatitis c, or uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past six months, uncontrolled cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0021051 (UMLS CUI [4])
C0019693 (UMLS CUI [5])
C0019163 (UMLS CUI [6])
C0019196 (UMLS CUI [7])
C0421258 (UMLS CUI [8])
C1868885 (UMLS CUI [9])
C0742758 (UMLS CUI [10])
C0002965 (UMLS CUI [11])
C0027051 (UMLS CUI [12])
C0003811 (UMLS CUI [13,1])
C0205318 (UMLS CUI [13,2])
C0004936 (UMLS CUI [14,1])
C0525058 (UMLS CUI [14,2])
C0439801 (UMLS CUI [14,3])
C0748872 (UMLS CUI [15,1])
C0525058 (UMLS CUI [15,2])
C0439801 (UMLS CUI [15,3])
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