Diagnosis
Item
all* patients must have a histological or cytological diagnosis of metastatic disease or hematological malignancies expressing the muc1. patients must have metastatic disease, and have failed at least one regimen of standard based chemotherapy for metastatic disease as indicated in the following table. patients must have disease considered to be incurable by surgical or radiological intervention.
boolean
C0449575 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C0175969 (UMLS CUI [1,5])
C0205471 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0392920 (UMLS CUI [2,4])
C0231175 (UMLS CUI [2,5])
C0175969 (UMLS CUI [2,6])
Age and consent
Item
patients must be > 18 years of age, consenting to participate in the study.
boolean
C0001779 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
Measurable tumor
Item
patients must have at least one site of measurable tumor or measurable tumor marker.
boolean
C1302351 (UMLS CUI [1])
C0041365 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
Imaging baseline
Item
radiological and other relevant imaging studies, such as ct scans, must be performed within 4 weeks of the first treatment as a baseline to document extent of disease.
boolean
C0011923 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
C0449279 (UMLS CUI [1,3])
Recovery from previous therapy
Item
patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
boolean
C1882428 (UMLS CUI [1,1])
C0679637 (UMLS CUI [1,2])
C1882428 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0013221 (UMLS CUI [3,1])
C2826210 (UMLS CUI [3,2])
General health and performance status
Item
patients must have a performance status of 70% or greater on the karnofsky scale (ecog 0-2) and a minimal life expectancy of 12 months.
boolean
C0206065 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
Consent
Item
patients must sign an informed consent, and be mentally responsible.
boolean
C0021430 (UMLS CUI [1,1])
C0683673 (UMLS CUI [1,2])
MUC1 expression
Item
in multiple myeloma, muc1 expression will be tested after confirming that all inclusion/exclusion criteria are met and within the screening period.
boolean
C0026764 (UMLS CUI [1,1])
C0565975 (UMLS CUI [1,2])
C1548787 (UMLS CUI [1,3])
Inclusion criteria not fulfilled
Item
patients not fulfilling the above criteria.
boolean
C1512693 (UMLS CUI [1])
Comorbidities
Item
patients with a significant concurrent medical complication that in the judgment of the principal investigator could affect the patient's ability to tolerate or complete this study.
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
C0085732 (UMLS CUI [1,5])
Immunosuppressive treatment
Item
patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine. (first vaccination should be at least 30 days from end of immunosuppressive treatment)
boolean
C0021081 (UMLS CUI [1,1])
C0021053 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
C0221099 (UMLS CUI [1,4])
Prior irradiation
Item
subjects with prior irradiation to a field that includes more than 25 of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. however, patients who had standard pelvic field radiation as adjuvant therapy for rectal cancer are not excluded.
boolean
C1522449 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0005953 (UMLS CUI [2,2])
C0021079 (UMLS CUI [2,3])
C0750492 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C3162256 (UMLS CUI [3,2])
C0007113 (UMLS CUI [3,3])
Pregnancy and breastfeeding
Item
pregnant and breast feeding women will be excluded. premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Brain metastasis
Item
patients with brain metastasis.
boolean
C0220650 (UMLS CUI [1])
Infection
Item
patients with active infection.
boolean
C0009450 (UMLS CUI [1])
Viral infections
Item
patients with hiv-, HBS-Ag- and hcv-positive.
boolean
C0036743 (UMLS CUI [1,1])
C0521026 (UMLS CUI [1,2])
C3714514 (UMLS CUI [1,3])
C0019699 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
C0855842 (UMLS CUI [4])