Prostate carcinoma Whitmore-Jewett staging system | Secondary malignant neoplasm of prostate
Item
1. patients must have high-risk stage d1 or metastatic prostate cancer (d2), confirmed by review of histology.
boolean
C0600139 (UMLS CUI [1,1])
C1520141 (UMLS CUI [1,2])
C0347001 (UMLS CUI [2])
Operative Surgical Procedure Patients Recovered
Item
2. patients must have fully recovered from surgery.
boolean
C0543467 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0521108 (UMLS CUI [1,3])
Stable Disease | Progressive Disease | Radiography | Ultrasonography | X-Ray Computed Tomography | Hormone Therapy | Chemotherapy
Item
3. patients must show stable or progressive disease as assessed by x-ray, ultrasound, and/or ct scans under hormonal and/or chemotherapeutic treatment, that had been administered for at least three months.
boolean
C0677946 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0034571 (UMLS CUI [3])
C0041618 (UMLS CUI [4])
C0040405 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C0392920 (UMLS CUI [7])
Chemotherapy Pretreatment Discontinued | Therapeutic radiology procedure Pretreatment Discontinued | Hormone Therapy
Item
4. any pretreatment with chemo- or radiotherapy must have been discontinued for at least four weeks prior to first dose of study agent. hormone therapy is allowed before and throughout the study.
boolean
C0392920 (UMLS CUI [1,1])
C3539075 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C3539075 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0279025 (UMLS CUI [3])
Life Expectancy
Item
5. patients must have an expected survival of at least three months.
boolean
C0023671 (UMLS CUI [1])
Karnofsky Performance Status
Item
6. patients must have a karnofsky performance status of 70% or more.
boolean
C0206065 (UMLS CUI [1])
Laboratory Results Normal Range
Item
7. within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:
boolean
C1254595 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
White Blood Cell Count procedure
Item
leukocytes >3.000/ul
boolean
C0023508 (UMLS CUI [1])
Lymphocyte Count measurement
Item
lymphocytes >700/ul
boolean
C0200635 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >100.000/ul
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine <2.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
alt, ast, and total bilirubin all < 2.5 x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C1278039 (UMLS CUI [3])
Age
Item
8. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
9. able to give valid written informed consent.
boolean
C0021430 (UMLS CUI [1])
Heart Disease Clinical Significance New York Heart Association Classification
Item
1. clinically significant heart disease (nyha class iii or iv).
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Illness Serious | Communicable Diseases Requirement Antibiotics | Blood Coagulation Disorders
Item
2. other serious illnesses, eg, active infections requiring antibiotics, bleeding disorders.
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0003232 (UMLS CUI [2,3])
C0005779 (UMLS CUI [3])
systemic steroids | topical steroids | Steroids Inhalation
Item
3. concomitant systemic treatment with corticosteroids. topical or inhalational steroids are permitted.
boolean
C2825233 (UMLS CUI [1])
C2064827 (UMLS CUI [2])
C0038317 (UMLS CUI [3,1])
C0205535 (UMLS CUI [3,2])
CNS metastases
Item
4. metastatic disease to the central nervous system.
boolean
C0686377 (UMLS CUI [1])
Mental impairment Limiting Informed Consent | Mental impairment Limiting Protocol Compliance
Item
5. mental impairment, in the opinion of the investigator, that may compromise the ability to give informed consent and comply with the requirements of the study.
boolean
C0683322 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0683322 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
Follow-up immunological Availability Lack | Follow-up Clinical Availability Lack
Item
6. lack of availability for immunological and clinical follow-up assessments.
boolean
C3274571 (UMLS CUI [1,1])
C0205470 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0332268 (UMLS CUI [1,4])
C3274571 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
C0332268 (UMLS CUI [2,4])
Study Subject Participation Status | Chemotherapy | Therapeutic radiology procedure | Investigational New Drugs
Item
7. participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to first dosing.
boolean
C2348568 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Recipient organ | Recipient Bone Marrow Allograft | Autoimmune Diseases | Vitiligo | Inflammatory Bowel Diseases | Multiple Sclerosis
Item
8. being a recipient of an organ or bone marrow allograft. having an autoimmune disease other than vitiligo, such as, but not limited to, inflammatory bowel disease or multiple sclerosis.
boolean
C1709854 (UMLS CUI [1,1])
C0524930 (UMLS CUI [1,2])
C1709854 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0450127 (UMLS CUI [2,3])
C0004364 (UMLS CUI [3])
C0042900 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0026769 (UMLS CUI [6])