ID

25199

Description

A Phase II Study of EC17 (Folate-hapten Conjugate) in Patients With Progressive Metastatic Renal Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT00485563

Link

https://clinicaltrials.gov/show/NCT00485563

Keywords

Versions (1)
  1. 8/28/17 8/28/17 -
Uploaded on

August 28, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00485563

English

Eligibility Renal Cell Carcinoma NCT00485563

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Description

Clear Cell Renal Carcinoma | Renal Cell Carcinoma Predominately Clear Cell | Histology Papillary

Data type

boolean

Alias
UMLS CUI [1]
C0279702
UMLS CUI [2,1]
C0007134
UMLS CUI [2,2]
C0332251
UMLS CUI [2,3]
C0229473
UMLS CUI [3,1]
C4048239
UMLS CUI [3,2]
C0205312
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)
Description

Recurrent disease | Disease TNM clinical staging | Disease unresectable | Systemic therapy | Disease Progression | Kinase inhibitor Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C3258246
UMLS CUI [3,1]
C0012634
UMLS CUI [3,2]
C1519810
UMLS CUI [4]
C1515119
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C3537035
UMLS CUI [6,2]
C1265611
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
Description

Measurable Disease Site metastatic | Evaluable Disease Site metastatic | Therapeutic radiology procedure Absent | Intervention Palliative Redundant

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1522484
UMLS CUI [2,1]
C1516986
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C1522484
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C1285530
UMLS CUI [4,3]
C1313915
must have at least one tumor lesion that displays uptake of 99mtc-ec20
Description

Tumor lesion Quantity | Uptake 99mTC-EC20

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0243144
UMLS CUI [2,2]
C1883272
must be > than or = 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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
Description

Gender Childbearing Potential Lacking | Gender Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3831118
UMLS CUI [1,3]
C0332268
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430061
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.
Description

Cytotoxic Chemotherapy Completed | Therapeutic radiology procedure Completed | Immunotherapy Completed | Investigational Therapy Completed | Toxicity Patient recovered | Palliative course of radiotherapy Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0677881
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0205197
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0205197
UMLS CUI [4,1]
C0949266
UMLS CUI [4,2]
C0205197
UMLS CUI [5,1]
C0600688
UMLS CUI [5,2]
C1115804
UMLS CUI [6,1]
C0475092
UMLS CUI [6,2]
C2828389
must have an ecog score less than or equal to 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must have adequate hematologic, renal, and heptic function
Description

Hematologic function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Description

Severe allergy Fluorescein CTCAE Grades | Severe allergy Contrast Media CTCAE Grades | Severe allergy Cytokines CTCAE Grades | Fluorescein

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0060520
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0009924
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C2945656
UMLS CUI [3,2]
C0079189
UMLS CUI [3,3]
C1516728
UMLS CUI [4]
C0060520
must not have medical conditions that preclude the use of il-2 or ifn-α.
Description

Medical condition Excludes Interleukin-2 | Medical condition Excludes Interferon-alpha

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0021756
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0002199
must not be pregnant or breast-feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
must not be currently undergoing chemotherapy, anticancer hormonal therapy, and/or therapy with immunosuppressant agents
Description

Chemotherapy | Cancer hormonal therapy | Therapeutic immunosuppression

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0877050
UMLS CUI [3]
C0021079
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)
Description

Diphosphonates | Zometa | EC90 | GPI0100

Data type

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2]
C0939788
UMLS CUI [3]
C1831884
UMLS CUI [4]
C0935831
must not have any concomitant malignancy with the exception of basal cell or squamous cell carcinoma of skin
Description

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0034571
UMLS CUI [2]
C1504389
UMLS CUI [3]
C0021051
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C1292733
UMLS CUI [5,3]
C0525058
UMLS CUI [6,1]
C0221423
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C1261322
UMLS CUI [6,4]
C2349179
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C1292733
UMLS CUI [7,3]
C1261322
UMLS CUI [7,4]
C2349179
must not have been administered another radiopharmaceutical that would interfere with the assessment of 99mtc-ec20
Description

Radiopharmaceutical Interferes with Assessment 99mTC-EC20

Data type

boolean

Alias
UMLS CUI [1,1]
C0182638
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C1883272
must not be unable to tolerate conditions for radionuclide imaging
Description

Tolerance Radionuclide Imaging

Data type

boolean

Alias
UMLS CUI [1,1]
C0034537
UMLS CUI [1,2]
C0034606
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Similar models

Eligibility Renal Cell Carcinoma NCT00485563

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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