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])
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])