ID

13084

Description

Vector Delivery of the IL-12 Gene in Men With Prostate Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00406939

Link

https://clinicaltrials.gov/show/NCT00406939

Keywords

Versions (1)
  1. 1/15/16 1/15/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

January 15, 2016

DOI

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License

Creative Commons BY-NC 3.0
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Eligibility Prostatic Neoplasms NCT00406939

English

Eligibility Prostatic Neoplasms NCT00406939

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after the hormone therapy, cryosurgery, and/or the completion of definitive radiation therapy for at least one year.
Description

prostate cancer

Data type

boolean

Alias
UMLS CUI [1]
C0600139
patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum psa level on at least 3 separate occasions at least 2 weeks apart, and that the serum psa be below 50 ng/ml.
Description

patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum psa level on at least 3 separate occasions at least 2 weeks apart, and that the serum psa be below 50 ng/ml.

Data type

boolean

Alias
UMLS CUI [1]
C0138741
the patient will possess the ability to give informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study. (informed consent document).
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol.
Description

organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
1. adequate renal function with serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 45 ml/min/m2.
Description

renal function

Data type

boolean

Alias
UMLS CUI [1]
C0201976
2. platelet count greater than 100,000 platelets/mm3.
Description

platelets

Data type

boolean

Alias
UMLS CUI [1]
C0005821
3. absolute neutrophil count greater than 1000/mm3.
Description

absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
4. hemoglobin greater than 8.5 mg/dl
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
5. normal partial thromboplastin time (ptt) and pro-thrombin time (pt).
Description

ptt and pt

Data type

boolean

Alias
UMLS CUI [1]
C0030605
6. bilirubin less than 2.5 mg/dl, sgot and sgpt less than 2.0x normal.
Description

liver function

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
acute infection: acute infection is defined as any viral, bacterial or fungal infection, which requires specific therapy.
Description

infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
symptomatic metastasis.
Description

metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
metastatic lesions in the cns/spinal cord or organs that could become life or function threatening within 3 months.
Description

metastatic lesions in the cns/spinal cord or organs that could become life or function threatening within 3 months

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Prostatic Neoplasms NCT00406939

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
prostate cancer
Item
men who have biopsy-proven local recurrence or persistence of cancer in the prostate gland with or without metastatic disease after the hormone therapy, cryosurgery, and/or the completion of definitive radiation therapy for at least one year.
boolean
C0600139 (UMLS CUI [1])
patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum psa level on at least 3 separate occasions at least 2 weeks apart, and that the serum psa be below 50 ng/ml.
Item
patients must have evidence of biologically active local recurrence of tumor as demonstrated by a rising serum psa level on at least 3 separate occasions at least 2 weeks apart, and that the serum psa be below 50 ng/ml.
boolean
C0138741 (UMLS CUI [1])
informed consent
Item
the patient will possess the ability to give informed consent and express a willingness to meet all the expected requirements of the protocol for the duration of the study. (informed consent document).
boolean
C0021430 (UMLS CUI [1])
organ function
Item
patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol.
boolean
C0678852 (UMLS CUI [1])
renal function
Item
1. adequate renal function with serum creatinine less than 1.5 mg/dl or creatinine clearance greater than 45 ml/min/m2.
boolean
C0201976 (UMLS CUI [1])
platelets
Item
2. platelet count greater than 100,000 platelets/mm3.
boolean
C0005821 (UMLS CUI [1])
absolute neutrophil count
Item
3. absolute neutrophil count greater than 1000/mm3.
boolean
C0948762 (UMLS CUI [1])
hemoglobin
Item
4. hemoglobin greater than 8.5 mg/dl
boolean
C0019046 (UMLS CUI [1])
ptt and pt
Item
5. normal partial thromboplastin time (ptt) and pro-thrombin time (pt).
boolean
C0030605 (UMLS CUI [1])
liver function
Item
6. bilirubin less than 2.5 mg/dl, sgot and sgpt less than 2.0x normal.
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
infection
Item
acute infection: acute infection is defined as any viral, bacterial or fungal infection, which requires specific therapy.
boolean
C0009450 (UMLS CUI [1])
metastasis
Item
symptomatic metastasis.
boolean
C0027627 (UMLS CUI [1])
metastatic lesions in the cns/spinal cord or organs that could become life or function threatening within 3 months
Item
metastatic lesions in the cns/spinal cord or organs that could become life or function threatening within 3 months.
boolean
C0023671 (UMLS CUI [1])
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