ID

44799

Description

A Study to Assess the Safety and Efficacy of MUC1 Peptide Vaccine and hGM-CSF in Patients With MUC1-positive Tumor Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT01232712

Link

https://clinicaltrials.gov/show/NCT01232712

Keywords

Versions (1)
  1. 11/30/21 11/30/21 - Tabea Kampen
Copyright Holder

Vaxil Therapeutics Ltd.

Uploaded on

November 30, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Multiple Myeloma NCT01232712

German English

Eligibility Multiple Myeloma NCT01232712

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
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.
Description

Diagnosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0449575
UMLS CUI [1,2]
C0027627
UMLS CUI [1,3]
C0392920
UMLS CUI [1,4]
C0231175
UMLS CUI [1,5]
C0175969
UMLS CUI [2,1]
C0205471
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0027627
UMLS CUI [2,4]
C0392920
UMLS CUI [2,5]
C0231175
UMLS CUI [2,6]
C0175969
patients must be > 18 years of age, consenting to participate in the study.
Description

Age and consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0021430
patients must have at least one site of measurable tumor or measurable tumor marker.
Description

Measurable tumor

Data type

boolean

Alias
UMLS CUI [1]
C1302351
UMLS CUI [2,1]
C0041365
UMLS CUI [2,2]
C1513040
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.
Description

Imaging baseline

Data type

boolean

Alias
UMLS CUI [1,1]
C0011923
UMLS CUI [1,2]
C1442488
UMLS CUI [1,3]
C0449279
patients should be at least 4 weeks beyond any major surgery or chemoradiotherapy and have recovered from drug induced toxicity.
Description

Recovery from previous therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1882428
UMLS CUI [1,2]
C0679637
UMLS CUI [2,1]
C1882428
UMLS CUI [2,2]
C0392920
UMLS CUI [3,1]
C0013221
UMLS CUI [3,2]
C2826210
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.
Description

General health and performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C0206065
UMLS CUI [1,2]
C0023671
patients must sign an informed consent, and be mentally responsible.
Description

Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0683673
in multiple myeloma, muc1 expression will be tested after confirming that all inclusion/exclusion criteria are met and within the screening period.
Description

MUC1 expression

Data type

boolean

Alias
UMLS CUI [1,1]
C0026764
UMLS CUI [1,2]
C0565975
UMLS CUI [1,3]
C1548787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients not fulfilling the above criteria.
Description

Inclusion criteria not fulfilled

Data type

boolean

Alias
UMLS CUI [1]
C1512693
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.
Description

Comorbidities

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C0205197
UMLS CUI [1,5]
C0085732
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)
Description

Immunosuppressive treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0021053
UMLS CUI [1,3]
C0521982
UMLS CUI [1,4]
C0221099
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.
Description

Prior irradiation

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0024204
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0005953
UMLS CUI [2,3]
C0021079
UMLS CUI [2,4]
C0750492
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C3162256
UMLS CUI [3,3]
C0007113
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.
Description

Pregnancy and breastfeeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
patients with brain metastasis.
Description

Brain metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patients with active infection.
Description

Infection

Data type

boolean

Alias
UMLS CUI [1]
C0009450
patients with hiv-, HBS-Ag- and hcv-positive.
Description

Viral infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0036743
UMLS CUI [1,2]
C0521026
UMLS CUI [1,3]
C3714514
UMLS CUI [2]
C0019699
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0855842
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Similar models

Eligibility Multiple Myeloma NCT01232712

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