Malignant Neoplasm Solid tumour | Patients Unresponsive to Treatment | Therapeutic procedure Toxic effect Unacceptable | Lymphoma Unresponsive to Treatment | Standard therapy Doxorubicin Regimen Quantity | Anti-CD20 Antibody Regimen Quantity | Disease Progression
Item
histologically-confirmed solid tumor malignancy (patients must be refractory to or demonstrate unacceptable toxicity towards effective therapy known to provide clinical benefit for their condition) or refractory lymphoma (patients whose disease has progressed despite standard therapy including at least one-doxorubicin-containing regimen and one anti-cd20 monoclonal antibody-containing regimen.
boolean
C0006826 (UMLS CUI [1,1])
C0280100 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0600688 (UMLS CUI [3,2])
C1883420 (UMLS CUI [3,3])
C0024299 (UMLS CUI [4,1])
C0205269 (UMLS CUI [4,2])
C2936643 (UMLS CUI [5,1])
C0013089 (UMLS CUI [5,2])
C0040808 (UMLS CUI [5,3])
C1265611 (UMLS CUI [5,4])
C3891557 (UMLS CUI [6,1])
C0040808 (UMLS CUI [6,2])
C1265611 (UMLS CUI [6,3])
C0242656 (UMLS CUI [7])
Karnofsky Performance Status
Item
kps ≥70%.
boolean
C0206065 (UMLS CUI [1])
Chemotherapy | Operative Surgical Procedures | Therapeutic radiology procedure | Adverse events resolved CTCAE Grades
Item
all adverse events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to nci ctcae (v. 3.0) grade ≤ 1 (except for hemoglobin).
boolean
C0392920 (UMLS CUI [1])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0877248 (UMLS CUI [4,1])
C1514893 (UMLS CUI [4,2])
C1516728 (UMLS CUI [4,3])
Bone Marrow function | Renal function | Normal adrenal function | Pancreatic function | Liver function
Item
adequate bone marrow, renal, adrenal, pancreatic and liver function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C3275461 (UMLS CUI [3])
C0232786 (UMLS CUI [4])
C0232741 (UMLS CUI [5])
Informed Consent
Item
signed informed consent.
boolean
C0021430 (UMLS CUI [1])
Chemotherapy | Biological treatment | Immunotherapy | Investigational New Drugs | Nitrosoureas | Mitomycin | Radioimmunotherapy | major surgery | Diagnostic surgical procedure | Therapeutic radiology procedure
Item
administration of chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 28 days prior to receipt of study medication (6 weeks for nitrosoureas or mitomycin c; 12 weeks for radioimmunotherapy). major surgery, other than diagnostic surgery, within 4 weeks before first study drug administration. radiotherapy within 4 weeks.
boolean
C0392920 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
C0028210 (UMLS CUI [5])
C0002475 (UMLS CUI [6])
C0085101 (UMLS CUI [7])
C0679637 (UMLS CUI [8])
C0522769 (UMLS CUI [9])
C1522449 (UMLS CUI [10])
Granulocyte Colony-Stimulating Factor Support Patient need for | Blood Platelets Support Patient need for
Item
patients that require g-csf and/or platelet support.
boolean
C0079459 (UMLS CUI [1,1])
C0344211 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0005821 (UMLS CUI [2,1])
C0344211 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Blood Coagulation Disorders
Item
patients with ongoing coagulopathies.
boolean
C0005779 (UMLS CUI [1])
Autologous bone marrow transplant | Allogeneic bone marrow transplantation
Item
patients with prior bone marrow transplant therapy (autologous or allogeneic).
boolean
C0194037 (UMLS CUI [1])
C0149615 (UMLS CUI [2])
intrathecal therapy
Item
patients receiving intrathecal therapy.
boolean
C1831734 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
known brain metastases.
boolean
C0220650 (UMLS CUI [1])
Heart Disease Significant
Item
significant cardiac disease.
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Hypersensitivity Propylene glycol CTCAE Grades | Allergy to ethanol CTCAE Grades
Item
patients with a prior hypersensitivity reaction of ctcae grade ≥ 3 to therapy containing propylene glycol or ethanol.
boolean
C0020517 (UMLS CUI [1,1])
C0072225 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0740909 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Postmenopausal state | Female Sterilization | Gender Contraceptive methods | Childbearing Potential Serum pregnancy test negative | Male sterilization
Item
pregnant or breast-feeding women. female patients must be postmenopausal, surgically sterile or they must agree to use acceptable methods of birth control. female patients with childbearing potential must have a negative serum pregnancy test. male patients must be surgically sterile or agree to use an acceptable method of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
C0079399 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C0024559 (UMLS CUI [7])
Therapeutic procedure Secondary Malignant Neoplasm
Item
concurrent, active secondary malignancy for which the patient is receiving therapy.
boolean
C0087111 (UMLS CUI [1,1])
C3266877 (UMLS CUI [1,2])
Bacterial Infection Uncontrolled Requirement systemic therapy | Mycosis Uncontrolled Requirement systemic therapy | Communicable Disease Requirement Antibiotics Parenteral
Item
active uncontrolled bacterial or fungal infection requiring systemic therapy; infection requiring parenteral antibiotics.
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C1515119 (UMLS CUI [1,4])
C0026946 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1515119 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0003232 (UMLS CUI [3,3])
C1518896 (UMLS CUI [3,4])
HIV Seropositivity | Hepatitis A | Hepatitis B | Hepatitis C
Item
known to be positive for hiv; active hepatitis a, b, or c infection.
boolean
C0019699 (UMLS CUI [1])
C0019159 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])