Clear Cell Renal Carcinoma | Renal Cell Carcinoma Predominately Clear Cell | Histology Papillary
Item
must have a histologically confirmed diagnosis of renal cell carcinoma (clear cell or predominately clear cell component). papillary histology may also be enrolled (maximum of 6 patients)
boolean
C0279702 (UMLS CUI [1])
C0007134 (UMLS CUI [2,1])
C0332251 (UMLS CUI [2,2])
C0229473 (UMLS CUI [2,3])
C4048239 (UMLS CUI [3,1])
C0205312 (UMLS CUI [3,2])
Recurrent disease | Disease TNM clinical staging | Disease unresectable | Systemic therapy | Disease Progression | Kinase inhibitor Quantity
Item
must be diagnosed with relapsed or stage iv disease that is medically or surgically unresectable and that has progressed after systemic therapy, including at least one agent in the general class of kinase inhibitors (tki not required for papillary histology)
boolean
C0277556 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0012634 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
C1515119 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
C3537035 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
Measurable Disease Site metastatic | Evaluable Disease Site metastatic | Therapeutic radiology procedure Absent | Intervention Palliative Redundant
Item
must have measurable/evaluable metastatic disease sites that have not previously received radiotherapy and which does not require palliative intervention (at the time of enrollment). patients with non-measurable/evaluable disease are ineligible
boolean
C1513041 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1522484 (UMLS CUI [1,3])
C1516986 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C1522484 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0184661 (UMLS CUI [4,1])
C1285530 (UMLS CUI [4,2])
C1313915 (UMLS CUI [4,3])
Tumor lesion Quantity | Uptake 99mTC-EC20
Item
must have at least one tumor lesion that displays uptake of 99mtc-ec20
boolean
C0027651 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0243144 (UMLS CUI [2,1])
C1883272 (UMLS CUI [2,2])
Age
Item
must be > than or = 18 years of age
boolean
C0001779 (UMLS CUI [1])
Gender Childbearing Potential Lacking | Gender Serum pregnancy test negative
Item
women must either be 1)not of child-bearing potential of 2)have a negative serum pregnancy test within 7 days prior to commencing treatment with investigational agents
boolean
C0079399 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2,1])
C0430061 (UMLS CUI [2,2])
Cytotoxic Chemotherapy Completed | Therapeutic radiology procedure Completed | Immunotherapy Completed | Investigational Therapy Completed | Toxicity Patient recovered | Palliative course of radiotherapy Excluded
Item
must have completed prior cytotoxic chemotherapy, radiotherapy, immunotherapy or experimental therapy 30 or more days prior to study enrollment, and recovered (or returned to baseline) from associated acute toxicities. this restriction excludes palliative radiotherapy.
boolean
C0677881 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
C0949266 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C0600688 (UMLS CUI [5,1])
C1115804 (UMLS CUI [5,2])
C0475092 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
ECOG performance status
Item
must have an ecog score less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Renal function | Liver function
Item
must have adequate hematologic, renal, and heptic function
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Severe allergy Fluorescein CTCAE Grades | Severe allergy Contrast Media CTCAE Grades | Severe allergy Cytokines CTCAE Grades | Fluorescein
Item
must not have a history of severe hypersensitivity (grade 3 - 4 allergic reaction) to fluorescein, radiological contrast agent, cytokines, or have received fluorescein within 30 days of the study
boolean
C2945656 (UMLS CUI [1,1])
C0060520 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C2945656 (UMLS CUI [2,1])
C0009924 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C2945656 (UMLS CUI [3,1])
C0079189 (UMLS CUI [3,2])
C1516728 (UMLS CUI [3,3])
C0060520 (UMLS CUI [4])
Medical condition Excludes Interleukin-2 | Medical condition Excludes Interferon-alpha
Item
must not have medical conditions that preclude the use of il-2 or ifn-α.
boolean
C3843040 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0021756 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0002199 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
must not be pregnant or breast-feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Chemotherapy | Cancer hormonal therapy | Therapeutic immunosuppression
Item
must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy with immunosuppressant agents
boolean
C0392920 (UMLS CUI [1])
C0877050 (UMLS CUI [2])
C0021079 (UMLS CUI [3])
Diphosphonates | Zometa | EC90 | GPI0100
Item
must not be currently receiving bisphosphonates such as zometa® (unless started > four weeks prior to treatment with ec90/gpi-0100, in which case they can be continued)
boolean
C0012544 (UMLS CUI [1])
C0939788 (UMLS CUI [2])
C1831884 (UMLS CUI [3])
C0935831 (UMLS CUI [4])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
must not have any concomitant malignancy with the exception of basal cell or squamous cell carcinoma of skin
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain Radiography | Stem cell transplant | Immunologic Deficiency Syndromes | Illness Preventing Protocol Compliance | Mental disorders Preventing Protocol Compliance | Illness Preventing Evaluation Endpoints | Mental disorders Preventing Evaluation Endpoints
Item
must not have radiographically documented evidence of current brain metastases, a history of stem cell transplant, immunodeficiency, and/or a medical or psychiatric illness (that in the investigator's opinion, would prevent adequate compliance with study therapy or evaluation of the endpoints)
boolean
C0220650 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
C1504389 (UMLS CUI [2])
C0021051 (UMLS CUI [3])
C0221423 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C1292733 (UMLS CUI [5,2])
C0525058 (UMLS CUI [5,3])
C0221423 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
C2349179 (UMLS CUI [6,4])
C0004936 (UMLS CUI [7,1])
C1292733 (UMLS CUI [7,2])
C1261322 (UMLS CUI [7,3])
C2349179 (UMLS CUI [7,4])
Radiopharmaceutical Interferes with Assessment 99mTC-EC20
Item
must not have been administered another radiopharmaceutical that would interfere with the assessment of 99mtc-ec20
boolean
C0182638 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C1883272 (UMLS CUI [1,4])
Tolerance Radionuclide Imaging
Item
must not be unable to tolerate conditions for radionuclide imaging
boolean
C0034537 (UMLS CUI [1,1])
C0034606 (UMLS CUI [1,2])