ID

42914

Descrizione

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Keywords

versioni (2)
  1. 29/10/20 29/10/20 -
  2. 17/09/21 17/09/21 -
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GlaxoSmithKline

Caricato su

17 settembre 2021

DOI

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Licenza

Creative Commons BY 4.0
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Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162

Inglese

Eligibility Check (Annex Report 2 Final)

1 moduli  
Administrative
Descrizione

Administrative

Alias
UMLS CUI-1
C1320722
Patient Number
Descrizione

Patient Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Eligibility Check
Descrizione

Eligibility Check

Alias
UMLS CUI-1
C0013893
Did the patient meet all the entry criteria?
Descrizione

Did the patient meet all the entry criteria?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
Descrizione

Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0205462
UMLS CUI [2]
C0456369
UMLS CUI [3,1]
C0151779
UMLS CUI [3,2]
C0027627
UMLS CUI [4]
C1513041
Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification [AJCC, 2002], this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.
Descrizione

Regional lymph node metastasis present; Cutaneous | Regional lymph node metastasis present; subcutaneous | Distant metastasis present; Cutaneous | Distant metastasis present; subcutaneous | Disease; Operative Surgical Procedures; Cure (remedy) | AJCC tumor staging | Unresectable; Stage level 3; melanoma | In-Transit Metastasis | melanoma; Stage level 4; Metastasis stage M1a

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1275854
UMLS CUI [1,2]
C0221912
UMLS CUI [2,1]
C1275854
UMLS CUI [2,2]
C0443315
UMLS CUI [3,1]
C1275402
UMLS CUI [3,2]
C0221912
UMLS CUI [4,1]
C1275402
UMLS CUI [4,2]
C0443315
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0543467
UMLS CUI [5,3]
C1880198
UMLS CUI [6]
C0441915
UMLS CUI [7,1]
C1519810
UMLS CUI [7,2]
C0441771
UMLS CUI [7,3]
C0025202
UMLS CUI [8]
C2985554
UMLS CUI [9,1]
C0025202
UMLS CUI [9,2]
C0441772
UMLS CUI [9,3]
C0445036
Written informed consent obtained from the patient prior to performance of any study specific procedure.
Descrizione

Written informed consent obtained from the patient prior to performance of any study specific procedure.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Patient is ≥ 18 years at the time of signature of the informed consent form.
Descrizione

Patient is ≥ 18 years at the time of signature of the informed consent form.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
Descrizione

The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0962473
UMLS CUI [1,2]
C0017262
UMLS CUI [2]
C0599161
UMLS CUI [3,1]
C1292533
UMLS CUI [3,2]
C2827486
UMLS CUI [4]
C0220908
Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
Descrizione

Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1292533
UMLS CUI [1,2]
C2827486
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0445247
UMLS CUI [3,1]
C0962473
UMLS CUI [3,2]
C0017262
UMLS CUI [4,1]
C1708225
UMLS CUI [4,2]
C0681890
Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.This FFPE tissue should preferably come from the same (reference) lesion as the fresh tissue used for MAGE-A3 and gene signature testing but may be taken from a second lesion during the screening phase if the reference lesion does not provide sufficient tissue.
Descrizione

Formalin-fixed paraffin-embedded tissue specimen; Availability of | MAGEA3 protein, human; Laboratory Procedures | Gene Signature; Laboratory Procedures | C0221198 Lesion; Same | Tissue specimen; Fresh Specimen | Lesion; second (number) | Screening procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2711483
UMLS CUI [1,2]
C0470187
UMLS CUI [2,1]
C0962473
UMLS CUI [2,2]
C0022885
UMLS CUI [3,1]
C1708225
UMLS CUI [3,2]
C0022885
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C0445247
UMLS CUI [5,1]
C1292533
UMLS CUI [5,2]
C2827486
UMLS CUI [6,1]
C0221198
UMLS CUI [6,2]
C0205436
UMLS CUI [7]
C0220908
Patient fully recovered from any previous intervention (i.e., biopsy).
Descrizione

Patient fully recovered from any previous intervention (i.e., biopsy).

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2826210
UMLS CUI [1,2]
C1514463
UMLS CUI [2]
C0005558
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Descrizione

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: - Absolute neutrophil count ≥ 1.5 x 109/L - Platelet count ≥ 75 x 109/L - Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN) - Total bilirubin ≤ 1.5 times the ULN - Lactate Dehydrogenase (LDH) LDH ≤ ULN - Alanine transaminase (ALAT) ≤ 2.5 times the ULN - Aspartate aminotransferase (ASAT) ≤ 2.5 times ULN
Descrizione

Bone Marrow; Adequate | Renal function; Adequate | Liver function; Adequate | Laboratory; criteria; Standard (qualifier) | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0205411
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205411
UMLS CUI [3,1]
C0232741
UMLS CUI [3,2]
C0205411
UMLS CUI [4,1]
C0022877
UMLS CUI [4,2]
C0243161
UMLS CUI [4,3]
C1442989
UMLS CUI [5]
C0948762
UMLS CUI [6]
C0032181
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0201913
UMLS CUI [9]
C0202113
UMLS CUI [10]
C0201836
UMLS CUI [11]
C0201899
UMLS CUI [12]
C1519815
If the patient is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
Descrizione

When considering the enrolment of females of childbearing potential, please take note of the following definitions: • Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly (when applicable, as mentioned in the product label) for example abstinence, combined or progestogen oral contraceptives, injectable progestogen, implants of levonorgestrel, oestrogenic vaginal ring, percutaneous contraceptive patches or intrauterine device (IUD) or intrauterine system (IUS), vasectomy with documented azoospermia of the sole male partner or double barrier method (condom or occlusive cap plus spermicidal agent). For azoospermia, “documented” refers to the laboratory report of azoospermia required for documentation of acceptable vasectomy of the patient’s male partner. • Post-menopause: Menopause is the age associated with complete cessation of menstrual cycles, menses, and implies the loss of reproductive potential by ovarian failure. A practical definition accepts menopause after 1 year without menses with an appropriate clinical profile at the appropriate age e.g.,> 45 years.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0520483
UMLS CUI [3]
C0020699
UMLS CUI [4]
C0029936
UMLS CUI [5]
C0232970
UMLS CUI [6]
C0700589
UMLS CUI [7]
C0427780
In the opinion of the investigator, the patient can and will comply with the protocol requirements.
Descrizione

In the opinion of the investigator, the patient can and will comply with the protocol requirements.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0582783
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
Descrizione

Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0025202
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0441772
UMLS CUI [2,2]
C0441971
UMLS CUI [3]
C0558356
UMLS CUI [4]
C3898222
The patient has at any time received any systemic anticancer treatment. • Prior systemic treatment with an immunomodulator (i.e., interferon or/and anti-CTL-A4 therapy) or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial; • Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial. • Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial.
Descrizione

cancer treatment; Systemic | Interferon | Anti-CTLA-4 Monoclonal Antibody | Therapeutic radiology procedure; Local; regional | Adjuvant therapy; Before | Dosage; Last | Cancer Vaccines | Tumor Antigens | MAGEA3 protein, human | Isolated limb perfusion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2]
C3652465
UMLS CUI [3]
C4289973
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C0205276
UMLS CUI [4,3]
C0205147
UMLS CUI [5,1]
C0677850
UMLS CUI [5,2]
C0332152
UMLS CUI [6,1]
C0178602
UMLS CUI [6,2]
C1517741
UMLS CUI [7]
C0376659
UMLS CUI [8]
C0041361
UMLS CUI [9]
C0962473
UMLS CUI [10]
C0396670
The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
Descrizione

The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205369
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0205394
UMLS CUI [4]
C3665472
UMLS CUI [5]
C0021081
The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents. The use of prednisone, or equivalent, at a dose of ≤ 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
Descrizione

Concomitant Therapy; chronic | systemic steroids | Immunosuppressive Agents; Other | prednisone; Medication dose | topical steroids

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C2825233
UMLS CUI [3,1]
C0021081
UMLS CUI [3,2]
C0205394
UMLS CUI [4,1]
C0032952
UMLS CUI [4,2]
C3174092
UMLS CUI [5]
C2064827
The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
Descrizione

The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0026769
UMLS CUI [3]
C0409974
UMLS CUI [4]
C0021390
UMLS CUI [5]
C0042900
The patient has a family history of congenital or hereditary immunodeficiency.
Descrizione

The patient has a family history of congenital or hereditary immunodeficiency.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0853602
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
The patient is known to be positive for Human Immunodeficiency Virus (HIV).
Descrizione

The patient is known to be positive for Human Immunodeficiency Virus (HIV).

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019699
History of allergic disease or reactions likely to be exacerbated by any component of ASCI treatment.
Descrizione

History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C4086268
UMLS CUI [3]
C1705248
UMLS CUI [4,1]
C0872278
UMLS CUI [4,2]
C0439859
The patient has previous or concomitant malignancies at other sites, except • Effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix • Effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
Descrizione

Comorbidity; Malignant Neoplasms | Anatomic Site; Other | Skin carcinoma | Carcinoma in situ of uterine cervix

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205394
UMLS CUI [3]
C0699893
UMLS CUI [4]
C0851140
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
Descrizione

The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0085281
UMLS CUI [3]
C0021430
The patient has an uncontrolled bleeding disorder.
Descrizione

The patient has an uncontrolled bleeding disorder.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C3842135
The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Descrizione

The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0445356
UMLS CUI [3]
C1321605
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C1883420
Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
Descrizione

Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013227
UMLS CUI [3]
C0042210
Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Descrizione

Study Subject Participation Status; Investigational New Drugs; Pharmaceutical Preparations

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0013227
For female patients: the patient is pregnant or lactating.
Descrizione

For female patients: the patient is pregnant or lactating.

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0006147
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Similar models

Eligibility Check (Annex Report 2 Final)

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Did the patient meet all the entry criteria?
Item
Did the patient meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
Item
Male or female patients with histologically proven metastatic cutaneous melanoma that is measurable
boolean
C0205462 (UMLS CUI [1])
C0456369 (UMLS CUI [2])
C0151779 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4])
Regional lymph node metastasis present; Cutaneous | Regional lymph node metastasis present; subcutaneous | Distant metastasis present; Cutaneous | Distant metastasis present; subcutaneous | Disease; Operative Surgical Procedures; Cure (remedy) | AJCC tumor staging | Unresectable; Stage level 3; melanoma | In-Transit Metastasis | melanoma; Stage level 4; Metastasis stage M1a
Item
Patients with regional or distant cutaneous, subcutaneous or lymph-node metastasis can be included in the study, provided the disease is not amenable to curative treatment with surgery. In terms of the AJCC 2002 classification [AJCC, 2002], this includes patients with unresectable stage III melanoma including in-transit metastases or patient with stage IV M1a melanoma.
boolean
C1275854 (UMLS CUI [1,1])
C0221912 (UMLS CUI [1,2])
C1275854 (UMLS CUI [2,1])
C0443315 (UMLS CUI [2,2])
C1275402 (UMLS CUI [3,1])
C0221912 (UMLS CUI [3,2])
C1275402 (UMLS CUI [4,1])
C0443315 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C1880198 (UMLS CUI [5,3])
C0441915 (UMLS CUI [6])
C1519810 (UMLS CUI [7,1])
C0441771 (UMLS CUI [7,2])
C0025202 (UMLS CUI [7,3])
C2985554 (UMLS CUI [8])
C0025202 (UMLS CUI [9,1])
C0441772 (UMLS CUI [9,2])
C0445036 (UMLS CUI [9,3])
Written informed consent obtained from the patient prior to performance of any study specific procedure.
Item
Written informed consent obtained from the patient prior to performance of any study specific procedure.
boolean
C0021430 (UMLS CUI [1])
Patient is ≥ 18 years at the time of signature of the informed consent form.
Item
Patient is ≥ 18 years at the time of signature of the informed consent form.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
Item
The patient’s tumor expresses MAGE-A3, as determined by RT-PCR analysis on a fresh tumor tissue sample obtained during the screening phase.
boolean
C0962473 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0599161 (UMLS CUI [2])
C1292533 (UMLS CUI [3,1])
C2827486 (UMLS CUI [3,2])
C0220908 (UMLS CUI [4])
Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
Item
Fresh tissue from the same lesion must be available for MAGE-A3 expression testing and for the testing of the predictive gene signature
boolean
C1292533 (UMLS CUI [1,1])
C2827486 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0445247 (UMLS CUI [2,2])
C0962473 (UMLS CUI [3,1])
C0017262 (UMLS CUI [3,2])
C1708225 (UMLS CUI [4,1])
C0681890 (UMLS CUI [4,2])
Formalin-fixed paraffin-embedded tissue specimen; Availability of | MAGEA3 protein, human; Laboratory Procedures | Gene Signature; Laboratory Procedures | C0221198 Lesion; Same | Tissue specimen; Fresh Specimen | Lesion; second (number) | Screening procedure
Item
Formalin-fixed paraffin-embedded (FFPE) tissue must be available for complementary MAGE-A3 and gene signature testing.This FFPE tissue should preferably come from the same (reference) lesion as the fresh tissue used for MAGE-A3 and gene signature testing but may be taken from a second lesion during the screening phase if the reference lesion does not provide sufficient tissue.
boolean
C2711483 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0962473 (UMLS CUI [2,1])
C0022885 (UMLS CUI [2,2])
C1708225 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C0445247 (UMLS CUI [4,2])
C1292533 (UMLS CUI [5,1])
C2827486 (UMLS CUI [5,2])
C0221198 (UMLS CUI [6,1])
C0205436 (UMLS CUI [6,2])
C0220908 (UMLS CUI [7])
Patient fully recovered from any previous intervention (i.e., biopsy).
Item
Patient fully recovered from any previous intervention (i.e., biopsy).
boolean
C2826210 (UMLS CUI [1,1])
C1514463 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Item
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Bone Marrow; Adequate | Renal function; Adequate | Liver function; Adequate | Laboratory; criteria; Standard (qualifier) | Absolute neutrophil count | Platelet Count measurement | Creatinine measurement, serum (procedure) | Bilirubin, total measurement | Lactate dehydrogenase measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Upper Limit of Normal
Item
Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: - Absolute neutrophil count ≥ 1.5 x 109/L - Platelet count ≥ 75 x 109/L - Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN) - Total bilirubin ≤ 1.5 times the ULN - Lactate Dehydrogenase (LDH) LDH ≤ ULN - Alanine transaminase (ALAT) ≤ 2.5 times the ULN - Aspartate aminotransferase (ASAT) ≤ 2.5 times ULN
boolean
C0005953 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205411 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3,1])
C0205411 (UMLS CUI [3,2])
C0022877 (UMLS CUI [4,1])
C0243161 (UMLS CUI [4,2])
C1442989 (UMLS CUI [4,3])
C0948762 (UMLS CUI [5])
C0032181 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0201913 (UMLS CUI [8])
C0202113 (UMLS CUI [9])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
C1519815 (UMLS CUI [12])
Childbearing Potential | Tubal Ligation | Hysterectomy | Ovariectomy | Postmenopausal state | Contraceptive methods | Pregnancy test negative
Item
If the patient is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for at least 30 days prior to registration in the trial, have a negative pregnancy test and continue such precautions during the entire study treatment period and for 2 months after completion of the injection series.
boolean
C3831118 (UMLS CUI [1])
C0520483 (UMLS CUI [2])
C0020699 (UMLS CUI [3])
C0029936 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
C0700589 (UMLS CUI [6])
C0427780 (UMLS CUI [7])
In the opinion of the investigator, the patient can and will comply with the protocol requirements.
Item
In the opinion of the investigator, the patient can and will comply with the protocol requirements.
boolean
C0582783 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
Item
Patients with unresectable stage IV M1b,c melanoma and patients with ocular and mucosal melanoma.
boolean
C0025202 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0441772 (UMLS CUI [2,1])
C0441971 (UMLS CUI [2,2])
C0558356 (UMLS CUI [3])
C3898222 (UMLS CUI [4])
cancer treatment; Systemic | Interferon | Anti-CTLA-4 Monoclonal Antibody | Therapeutic radiology procedure; Local; regional | Adjuvant therapy; Before | Dosage; Last | Cancer Vaccines | Tumor Antigens | MAGEA3 protein, human | Isolated limb perfusion
Item
The patient has at any time received any systemic anticancer treatment. • Prior systemic treatment with an immunomodulator (i.e., interferon or/and anti-CTL-A4 therapy) or loco-regional radiotherapy is permitted as prior adjuvant treatment provided that the last dose was administered at least 30 days before the registration into this trial; • Previous adjuvant treatment with a cancer vaccine containing a tumor antigen other than MAGE-A3 is allowed if the last administration took place at least 8 weeks before registration into the trial. • Prior isolated limb perfusion is permitted provided that the last dose was administered at least 30 days before registration into this trial.
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2])
C4289973 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C0205276 (UMLS CUI [4,2])
C0205147 (UMLS CUI [4,3])
C0677850 (UMLS CUI [5,1])
C0332152 (UMLS CUI [5,2])
C0178602 (UMLS CUI [6,1])
C1517741 (UMLS CUI [6,2])
C0376659 (UMLS CUI [7])
C0041361 (UMLS CUI [8])
C0962473 (UMLS CUI [9])
C0396670 (UMLS CUI [10])
The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
Item
The patient is scheduled to receive any anti-cancer specific treatment, including radiotherapy, other immunotherapy, chemotherapy and immunomodulating agents.
boolean
C0920425 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C3665472 (UMLS CUI [4])
C0021081 (UMLS CUI [5])
Concomitant Therapy; chronic | systemic steroids | Immunosuppressive Agents; Other | prednisone; Medication dose | topical steroids
Item
The patient requires concomitant chronic treatment (more than 7 consecutive days) with systemic corticosteroids, or any other immunosuppressive agents. The use of prednisone, or equivalent, at a dose of ≤ 0.125 mg/kg/day (absolute maximum 10 mg/day) or topical steroids is permitted.
boolean
C1707479 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C2825233 (UMLS CUI [2])
C0021081 (UMLS CUI [3,1])
C0205394 (UMLS CUI [3,2])
C0032952 (UMLS CUI [4,1])
C3174092 (UMLS CUI [4,2])
C2064827 (UMLS CUI [5])
The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
Item
The patient has a history of autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
boolean
C0004364 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0021390 (UMLS CUI [4])
C0042900 (UMLS CUI [5])
The patient has a family history of congenital or hereditary immunodeficiency.
Item
The patient has a family history of congenital or hereditary immunodeficiency.
boolean
C0853602 (UMLS CUI [1])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
The patient is known to be positive for Human Immunodeficiency Virus (HIV).
Item
The patient is known to be positive for Human Immunodeficiency Virus (HIV).
boolean
C0019699 (UMLS CUI [1])
History of allergic disease or reactions likely to be exacerbated by any component of the ASCI treatment.
Item
History of allergic disease or reactions likely to be exacerbated by any component of ASCI treatment.
boolean
C0020517 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C1705248 (UMLS CUI [3])
C0872278 (UMLS CUI [4,1])
C0439859 (UMLS CUI [4,2])
Comorbidity; Malignant Neoplasms | Anatomic Site; Other | Skin carcinoma | Carcinoma in situ of uterine cervix
Item
The patient has previous or concomitant malignancies at other sites, except • Effectively treated non-melanoma skin cancer or carcinoma in situ of the cervix • Effectively treated malignancy that has been in remission for over 5 years and is highly likely to have been cured.
boolean
C0009488 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0699893 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
Item
The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent or to comply with the trial procedures.
boolean
C0004936 (UMLS CUI [1])
C0085281 (UMLS CUI [2])
C0021430 (UMLS CUI [3])
The patient has an uncontrolled bleeding disorder.
Item
The patient has an uncontrolled bleeding disorder.
boolean
C3842135 (UMLS CUI [1])
The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Item
The patient has concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0445356 (UMLS CUI [2,2])
C1321605 (UMLS CUI [3])
C0035647 (UMLS CUI [4,1])
C1883420 (UMLS CUI [4,2])
Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
Item
Use of any investigational or non-registered product (drug or vaccine) other than the study medication within the 30 days preceding the first dose of study treatment or planned use during the study period.
boolean
C0013230 (UMLS CUI [1])
C0013227 (UMLS CUI [2])
C0042210 (UMLS CUI [3])
Study Subject Participation Status; Investigational New Drugs; Pharmaceutical Preparations
Item
Concurrently participating in another clinical study, at any time during the study period, in which the patient has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
For female patients: the patient is pregnant or lactating.
Item
For female patients: the patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
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