ID

27729

Beschrijving

MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00868595

Link

https://clinicaltrials.gov/show/NCT00868595

Trefwoorden

Versies (1)
  1. 27-11-17 27-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

27 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Castrate Resistant Prostate Cancer (CRPC) NCT00868595

Engels

Eligibility Castrate Resistant Prostate Cancer (CRPC) NCT00868595

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. males ≥ 18 years of age
Beschrijving

Gender | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
2. histological diagnosis of adenocarcinoma of the prostate
Beschrijving

Adenocarcinoma of prostate

Datatype

boolean

Alias
UMLS CUI [1]
C0007112
3. documented evidence of distant metastasis of disease
Beschrijving

Distant metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C1269798
4. no more than 1 prior chemotherapeutic, biologic or combination treatment regimen (including vitamin d analogues) for crpc. if previously treated, patients must be recovered from all toxicities prior to entry into the study.
Beschrijving

Chemotherapy Quantity CRPC | Biological treatment Quantity CRPC | Combined Modality Therapy Quantity CRPC | Vitamin D Analog Quantity CRPC | Prior Therapy | Toxicity Patient recovered

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1328504
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1328504
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1328504
UMLS CUI [4,1]
C2917444
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1328504
UMLS CUI [5]
C1514463
UMLS CUI [6,1]
C0600688
UMLS CUI [6,2]
C1115804
5. patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (lhrh analogue); anti-androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on antiandrogens and a duration of response to antiandrogens > 3months;
Beschrijving

Disease Progression | Male Castration | Orchiectomy | Medical Castration | LHRH Analogue | Androgen Antagonists Withdrawal | Flutamide | nilutamide | bicalutamide

Datatype

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C0007347
UMLS CUI [3]
C0029189
UMLS CUI [4]
C1513054
UMLS CUI [5]
C1518041
UMLS CUI [6,1]
C0002842
UMLS CUI [6,2]
C2349954
UMLS CUI [7]
C0016384
UMLS CUI [8]
C0068771
UMLS CUI [9]
C0285590
6. testosterone < 50 ng/dl achieved via medical or surgical castration. patients receiving medical castration therapy must continue such therapy throughout the study.
Beschrijving

Testosterone measurement Medical Castration | Testosterone measurement Male Castration | Medical Castration Continue

Datatype

boolean

Alias
UMLS CUI [1,1]
C0523912
UMLS CUI [1,2]
C1513054
UMLS CUI [2,1]
C0523912
UMLS CUI [2,2]
C0007347
UMLS CUI [3,1]
C1513054
UMLS CUI [3,2]
C0549178
7. adequate hematologic, renal and liver function:
Beschrijving

Hematologic function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
8. negative serology tests for human immunodeficiency virus (hiv-1 and 2), human t-cell lymphotropic virus (htlv-1), hepatitis b surface antigen (hbsag) and hepatitis c (hcv)
Beschrijving

Serology negative HIV-1 | Serology negative HIV-2 | Serology negative Human T-lymphotropic virus 1 | Serology negative Hepatitis B Surface Antigens | Serology negative Hepatitis C virus

Datatype

boolean

Alias
UMLS CUI [1,1]
C0919674
UMLS CUI [1,2]
C0019704
UMLS CUI [2,1]
C0919674
UMLS CUI [2,2]
C0019707
UMLS CUI [3,1]
C0919674
UMLS CUI [3,2]
C0020094
UMLS CUI [4,1]
C0919674
UMLS CUI [4,2]
C0019168
UMLS CUI [5,1]
C0919674
UMLS CUI [5,2]
C0220847
9. karnofsky performance score (kps) ≥ 70%
Beschrijving

Karnofsky Performance Status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
10. life expectancy > 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
11. written informed consent obtained prior to the initiation of study procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. the presence of brain metastases, pleural effusions or ascites
Beschrijving

Metastatic malignant neoplasm to brain | Pleural effusion | Ascites

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
2. pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%), or spinal cord compression
Beschrijving

Fractures of the long bones | Fractures of the long bones Expected | Cortical bone erosion Percentage Radiography | Compression of spinal cord

Datatype

boolean

Alias
UMLS CUI [1]
C0240231
UMLS CUI [2,1]
C0240231
UMLS CUI [2,2]
C1517001
UMLS CUI [3,1]
C0948713
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0034571
UMLS CUI [4]
C0037926
3. a history of stage iii or greater cancer, excluding prostate cancer. basal or squamous cell skin cancers must have been adequately treated and the patient must be disease-free at the time of registration. patients with a history of stage i or ii other cancers must have been adequately treated and been disease-free for 3 years at the time of registration.
Beschrijving

Malignant Neoplasms TNM clinical staging | Exception Prostate carcinoma | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Disease Free of | Malignant Neoplasms TNM clinical staging Treated

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600139
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [4,1]
C0553723
UMLS CUI [4,2]
C1522326
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0332296
UMLS CUI [6,1]
C0006826
UMLS CUI [6,2]
C3258246
UMLS CUI [6,3]
C1522326
4. more than 1 prior chemotherapy, biologic or combination treatment regimen (including vitamin d analogues) for crpc
Beschrijving

Chemotherapy Quantity CRPC | Biological treatment Quantity CRPC | Combined Modality Therapy Quantity CRPC | Vitamin D Analog Quantity CRPC

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1328504
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1328504
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1328504
UMLS CUI [4,1]
C2917444
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C1328504
5. any treatment with radiopharmaceuticals, e.g. strontium-89 and samarium-153
Beschrijving

Radiopharmaceuticals | Strontium-89 | Samarium-153

Datatype

boolean

Alias
UMLS CUI [1]
C0182638
UMLS CUI [2]
C0281385
UMLS CUI [3]
C0677942
6. ketoconazole or antiandrogens (flutamide, nilutamide, bicalutamide) within 2 weeks prior to registration. patients who demonstrate an anti-androgen withdrawal response, defined as a > 25% drop in psa within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen, are not eligible until the psa rises above the nadir observed after anti-androgen withdrawal.
Beschrijving

Ketoconazole | Androgen Antagonists | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Withdrawal Response | PSA decreased Percentage

Datatype

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2]
C0002842
UMLS CUI [3]
C0016384
UMLS CUI [4]
C0068771
UMLS CUI [5]
C0285590
UMLS CUI [6,1]
C0002842
UMLS CUI [6,2]
C2349954
UMLS CUI [6,3]
C0871261
UMLS CUI [7,1]
C0178414
UMLS CUI [7,2]
C0439165
7. initiation of bisphosphonate therapy within 28 days prior to registration. patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted.
Beschrijving

Diphosphonates Dose unchanged

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0442739
8. a requirement for systemic steroid or other immunosuppressive therapy for any reason.
Beschrijving

Systemic steroids Patient need for | Therapeutic immunosuppression Patient need for

Datatype

boolean

Alias
UMLS CUI [1,1]
C2825233
UMLS CUI [1,2]
C0686904
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0686904
9. treatment with any of the following medications or interventions < 28 days prior to screening
Beschrijving

Pharmaceutical Preparations | Intervention

Datatype

boolean

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0184661
10. treatment with any investigational vaccine within 2 years prior to screening, or treatment with any other investigational product within 28 days prior to screening
Beschrijving

Vaccines Investigational | Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1517586
UMLS CUI [2]
C0013230
11. any antibiotic therapy or infection within 1 week prior to screening, including unexplained fever (temperature ≥ 100.5f or 38.1c)
Beschrijving

Antibiotic therapy | Communicable Disease | Unexplained fever

Datatype

boolean

Alias
UMLS CUI [1]
C0338237
UMLS CUI [2]
C0009450
UMLS CUI [3]
C1844662
12. history of autoimmune disease
Beschrijving

Autoimmune Diseases

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
13. serious ongoing chronic or acute illness
Beschrijving

Chronic disease Serious | Illness Serious

Datatype

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0221423
UMLS CUI [2,2]
C0205404
14. any medical intervention or other condition which, in the opinion of the principal investigator and/or the bellicum medical monitor, could compromise adherence with study requirements
Beschrijving

Intervention compromises Protocol Compliance | Condition compromises Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
other criteria apply however are not listed
Beschrijving

Criteria Additional

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Castrate Resistant Prostate Cancer (CRPC) NCT00868595

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
1. males ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Adenocarcinoma of prostate
Item
2. histological diagnosis of adenocarcinoma of the prostate
boolean
C0007112 (UMLS CUI [1])
Distant metastasis
Item
3. documented evidence of distant metastasis of disease
boolean
C1269798 (UMLS CUI [1])
Chemotherapy Quantity CRPC | Biological treatment Quantity CRPC | Combined Modality Therapy Quantity CRPC | Vitamin D Analog Quantity CRPC | Prior Therapy | Toxicity Patient recovered
Item
4. no more than 1 prior chemotherapeutic, biologic or combination treatment regimen (including vitamin d analogues) for crpc. if previously treated, patients must be recovered from all toxicities prior to entry into the study.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1328504 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1328504 (UMLS CUI [3,3])
C2917444 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1328504 (UMLS CUI [4,3])
C1514463 (UMLS CUI [5])
C0600688 (UMLS CUI [6,1])
C1115804 (UMLS CUI [6,2])
Disease Progression | Male Castration | Orchiectomy | Medical Castration | LHRH Analogue | Androgen Antagonists Withdrawal | Flutamide | nilutamide | bicalutamide
Item
5. patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (lhrh analogue); anti-androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on antiandrogens and a duration of response to antiandrogens > 3months;
boolean
C0242656 (UMLS CUI [1])
C0007347 (UMLS CUI [2])
C0029189 (UMLS CUI [3])
C1513054 (UMLS CUI [4])
C1518041 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0016384 (UMLS CUI [7])
C0068771 (UMLS CUI [8])
C0285590 (UMLS CUI [9])
Testosterone measurement Medical Castration | Testosterone measurement Male Castration | Medical Castration Continue
Item
6. testosterone < 50 ng/dl achieved via medical or surgical castration. patients receiving medical castration therapy must continue such therapy throughout the study.
boolean
C0523912 (UMLS CUI [1,1])
C1513054 (UMLS CUI [1,2])
C0523912 (UMLS CUI [2,1])
C0007347 (UMLS CUI [2,2])
C1513054 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
Hematologic function | Renal function | Liver function
Item
7. adequate hematologic, renal and liver function:
boolean
C0221130 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Serology negative HIV-1 | Serology negative HIV-2 | Serology negative Human T-lymphotropic virus 1 | Serology negative Hepatitis B Surface Antigens | Serology negative Hepatitis C virus
Item
8. negative serology tests for human immunodeficiency virus (hiv-1 and 2), human t-cell lymphotropic virus (htlv-1), hepatitis b surface antigen (hbsag) and hepatitis c (hcv)
boolean
C0919674 (UMLS CUI [1,1])
C0019704 (UMLS CUI [1,2])
C0919674 (UMLS CUI [2,1])
C0019707 (UMLS CUI [2,2])
C0919674 (UMLS CUI [3,1])
C0020094 (UMLS CUI [3,2])
C0919674 (UMLS CUI [4,1])
C0019168 (UMLS CUI [4,2])
C0919674 (UMLS CUI [5,1])
C0220847 (UMLS CUI [5,2])
Karnofsky Performance Status
Item
9. karnofsky performance score (kps) ≥ 70%
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
10. life expectancy > 6 months
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
11. written informed consent obtained prior to the initiation of study procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain | Pleural effusion | Ascites
Item
1. the presence of brain metastases, pleural effusions or ascites
boolean
C0220650 (UMLS CUI [1])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
Fractures of the long bones | Fractures of the long bones Expected | Cortical bone erosion Percentage Radiography | Compression of spinal cord
Item
2. pathologic long-bone fractures, imminent pathologic long-bone fracture (cortical erosion on radiography > 50%), or spinal cord compression
boolean
C0240231 (UMLS CUI [1])
C0240231 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C0948713 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0034571 (UMLS CUI [3,3])
C0037926 (UMLS CUI [4])
Malignant Neoplasms TNM clinical staging | Exception Prostate carcinoma | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Disease Free of | Malignant Neoplasms TNM clinical staging Treated
Item
3. a history of stage iii or greater cancer, excluding prostate cancer. basal or squamous cell skin cancers must have been adequately treated and the patient must be disease-free at the time of registration. patients with a history of stage i or ii other cancers must have been adequately treated and been disease-free for 3 years at the time of registration.
boolean
C0006826 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0600139 (UMLS CUI [2,2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0553723 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0332296 (UMLS CUI [5,2])
C0006826 (UMLS CUI [6,1])
C3258246 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
Chemotherapy Quantity CRPC | Biological treatment Quantity CRPC | Combined Modality Therapy Quantity CRPC | Vitamin D Analog Quantity CRPC
Item
4. more than 1 prior chemotherapy, biologic or combination treatment regimen (including vitamin d analogues) for crpc
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1328504 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1328504 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1328504 (UMLS CUI [3,3])
C2917444 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C1328504 (UMLS CUI [4,3])
Radiopharmaceuticals | Strontium-89 | Samarium-153
Item
5. any treatment with radiopharmaceuticals, e.g. strontium-89 and samarium-153
boolean
C0182638 (UMLS CUI [1])
C0281385 (UMLS CUI [2])
C0677942 (UMLS CUI [3])
Ketoconazole | Androgen Antagonists | Flutamide | nilutamide | bicalutamide | Androgen Antagonists Withdrawal Response | PSA decreased Percentage
Item
6. ketoconazole or antiandrogens (flutamide, nilutamide, bicalutamide) within 2 weeks prior to registration. patients who demonstrate an anti-androgen withdrawal response, defined as a > 25% drop in psa within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non-steroidal anti-androgen, are not eligible until the psa rises above the nadir observed after anti-androgen withdrawal.
boolean
C0022625 (UMLS CUI [1])
C0002842 (UMLS CUI [2])
C0016384 (UMLS CUI [3])
C0068771 (UMLS CUI [4])
C0285590 (UMLS CUI [5])
C0002842 (UMLS CUI [6,1])
C2349954 (UMLS CUI [6,2])
C0871261 (UMLS CUI [6,3])
C0178414 (UMLS CUI [7,1])
C0439165 (UMLS CUI [7,2])
Diphosphonates Dose unchanged
Item
7. initiation of bisphosphonate therapy within 28 days prior to registration. patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted.
boolean
C0012544 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Systemic steroids Patient need for | Therapeutic immunosuppression Patient need for
Item
8. a requirement for systemic steroid or other immunosuppressive therapy for any reason.
boolean
C2825233 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Pharmaceutical Preparations | Intervention
Item
9. treatment with any of the following medications or interventions < 28 days prior to screening
boolean
C0013227 (UMLS CUI [1])
C0184661 (UMLS CUI [2])
Vaccines Investigational | Investigational New Drugs
Item
10. treatment with any investigational vaccine within 2 years prior to screening, or treatment with any other investigational product within 28 days prior to screening
boolean
C0042210 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2])
Antibiotic therapy | Communicable Disease | Unexplained fever
Item
11. any antibiotic therapy or infection within 1 week prior to screening, including unexplained fever (temperature ≥ 100.5f or 38.1c)
boolean
C0338237 (UMLS CUI [1])
C0009450 (UMLS CUI [2])
C1844662 (UMLS CUI [3])
Autoimmune Diseases
Item
12. history of autoimmune disease
boolean
C0004364 (UMLS CUI [1])
Chronic disease Serious | Illness Serious
Item
13. serious ongoing chronic or acute illness
boolean
C0008679 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0221423 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Intervention compromises Protocol Compliance | Condition compromises Protocol Compliance
Item
14. any medical intervention or other condition which, in the opinion of the principal investigator and/or the bellicum medical monitor, could compromise adherence with study requirements
boolean
C0184661 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Criteria Additional
Item
other criteria apply however are not listed
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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