ID

30373

Description

SNX-5422 to Treat Solid Tumor Cancers and Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT00644072

Lien

https://clinicaltrials.gov/show/NCT00644072

Mots-clés

Versions (1)
  1. 30/05/2018 30/05/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

30 mai 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Lymphoma NCT00644072

Anglais

Eligibility Lymphoma NCT00644072

1 Formulaires  
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00644072
Criteria
Description

Criteria

patients with histologically documented (by the nih pathology department) solid tumors and lymphoid malignancies (lymphoma and cll) who are refractory to standard therapy or who have no acceptable standard treatment options. patients with lymphoid malignancies will be eligible if their disease has progressed following 2 standard therapies (aggressive nhl), and if their disease is considered refractory (for indolent nhl).
Description

Solid Neoplasm | Malignant lymphoid neoplasm | Lymphoma | Chronic Lymphocytic Leukemia | Refractory Standard of Care | Standard of Care Absent | Disease Progression Post Standard of Care Quantity | Aggressive Non-Hodgkin Lymphoma | Refractory Disease | Indolent Non-Hodgkin Lymphoma

Type de données

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2]
C0746336
UMLS CUI [3]
C0024299
UMLS CUI [4]
C0023434
UMLS CUI [5,1]
C0205269
UMLS CUI [5,2]
C2936643
UMLS CUI [6,1]
C2936643
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0242656
UMLS CUI [7,2]
C0687676
UMLS CUI [7,3]
C2936643
UMLS CUI [7,4]
C1265611
UMLS CUI [8]
C1332225
UMLS CUI [9]
C1514815
UMLS CUI [10]
C1334170
patients must have measurable or evaluable disease.
Description

Measurable Disease | Evaluable Disease

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
patients must have recovered to at least grade less than or equal to1 toxicity levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy. they must not have had chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin c, or ucn-01). patients must be greater than or equal to 2 weeks since any prior administration of study drug in an exploratory ind/phase zero study. patients must be greater than or equal to 1 month since any prior radiation or major surgery. however, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy.
Description

Patient recovered Toxicity CTCAE Grades | Toxicity Due to Adverse event | Toxicity Due to Prior Chemotherapy | Toxicity Due to Biological treatment | Nitrosourea | Mitomycin | UCN 01 | Study Subject Participation Status | Investigational New Drugs | Prior radiation therapy | Major surgery | Diphosphonates Malignant Neoplasms | Antiandrogen therapy Prostate carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C1115804
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0877248
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C1514457
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C1531518
UMLS CUI [5]
C0028210
UMLS CUI [6]
C0002475
UMLS CUI [7]
C0950721
UMLS CUI [8]
C2348568
UMLS CUI [9]
C0013230
UMLS CUI [10]
C0279134
UMLS CUI [11]
C0679637
UMLS CUI [12,1]
C0012544
UMLS CUI [12,2]
C0006826
UMLS CUI [13,1]
C0279492
UMLS CUI [13,2]
C0600139
age greater than or equal to 18 years
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
the eastern cooperative oncology group (ecog) performance status less than or equal to 2 (karnofsky greater than or equal to 60%).
Description

ECOG performance status | Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
life expectancy greater than 3 months
Description

Life Expectancy

Type de données

boolean

Alias
UMLS CUI [1]
C0023671
patients must have normal or adequate organ and marrow function as defined below:
Description

Organ function | Bone Marrow function

Type de données

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
absolute neutrophil count greater than or equal to 1,500/milliliter
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
platelets greater than or equal to 100,000/milliliter
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin* within less than or equal to 1.5 times upper limit of normal
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
ast (sgot)/alt (sgpt) less than or equal to 2.5 times institutional upper limit of normal
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine less than 1.5 times upper limit of normal
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
creatinine clearance greater than or equal to 60 ml/min (measured) for patients with creatinine levels greater than or equal to 1.5 times upper limit of normal.
Description

Creatinine clearance measurement | Serum creatinine raised

Type de données

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C0700225
*we will allow patients with gilbert's syndrome with total bilirubin up to 2.5 mg/dl
Description

Gilbert Disease | Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0017551
UMLS CUI [2]
C1278039
the effects of snx-5422 on the developing human fetus are unknown. for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after discontinuation from the study. women of childbearing potential must have a negative pregnancy test in order to be eligible. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with snx-5422, breastfeeding should be discontinued if the mother is treated with snx-5422.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Pregnancy test negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0427780
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients receiving any other investigational agents. patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the principal investigator.
Description

Investigational New Drugs | Metastatic malignant neoplasm to brain Symptomatic | Prognosis bad | Development Frequently Progressive neurologic dysfunction | Interference Evaluation Neurological event | Interference Evaluation Adverse event

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0278252
UMLS CUI [4,1]
C0243107
UMLS CUI [4,2]
C0332183
UMLS CUI [4,3]
C4013375
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C1261322
UMLS CUI [5,3]
C1320718
UMLS CUI [6,1]
C0521102
UMLS CUI [6,2]
C1261322
UMLS CUI [6,3]
C0877248
uncontrolled medical illness including, but not limited to, ongoing or uncontrolled, symptomatic congestive heart failure (aha class ii or worse), uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Description

Illness Uncontrolled | Symptomatic congestive heart failure American Heart Association Class | Symptomatic congestive heart failure Uncontrolled American Heart Association Class | Uncontrolled hypertension | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited

Type de données

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0742758
UMLS CUI [2,2]
C0002458
UMLS CUI [2,3]
C0456387
UMLS CUI [3,1]
C0742758
UMLS CUI [3,2]
C0205318
UMLS CUI [3,3]
C0002458
UMLS CUI [3,4]
C0456387
UMLS CUI [4]
C1868885
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0003811
UMLS CUI [7,1]
C0004936
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0525058
UMLS CUI [8,3]
C0439801
hiv-positive patients receiving combination antiretroviral therapy are excluded from the study because of possible pk interactions with snx-5422. hiv positive patients not receiving antiretroviral therapy are excluded due to the possibility that snx-5422 may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to snx-5422.
Description

Antiretroviral therapy HIV Seropositivity | Pharmacokinetic interaction SNX-5422 | HIV Seropositivity | Risk Due to SNX-5422

Type de données

boolean

Alias
UMLS CUI [1,1]
C1963724
UMLS CUI [1,2]
C0019699
UMLS CUI [2,1]
C1868980
UMLS CUI [2,2]
C3253587
UMLS CUI [3]
C0019699
UMLS CUI [4,1]
C0035647
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C3253587
chronic diarrhea.
Description

Chronic diarrhea

Type de données

boolean

Alias
UMLS CUI [1]
C0401151
gastrointestinal diseases that could affect drug absorption, including postsurgical states such as gastric bypass.
Description

Gastrointestinal Diseases Affecting Drug absorption | Postoperative state | Gastric Bypass

Type de données

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0678745
UMLS CUI [2]
C0231287
UMLS CUI [3]
C0017125
gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, crohn's disease, or hemorrhagic coloproctitis.
Description

Gastrointestinal Diseases Changing Assessment Safety | Irritable Bowel Syndrome | Ulcerative Colitis | Crohn Disease | Hemorrhagic Proctocolitis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0017178
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C1516048
UMLS CUI [1,4]
C0036043
UMLS CUI [2]
C0022104
UMLS CUI [3]
C0009324
UMLS CUI [4]
C0010346
UMLS CUI [5]
C1257847
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Similar models

Eligibility Lymphoma NCT00644072

1 Formulaires
  1. StudyEvent: Eligibility
    1. Eligibility Lymphoma NCT00644072
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Solid Neoplasm | Malignant lymphoid neoplasm | Lymphoma | Chronic Lymphocytic Leukemia | Refractory Standard of Care | Standard of Care Absent | Disease Progression Post Standard of Care Quantity | Aggressive Non-Hodgkin Lymphoma | Refractory Disease | Indolent Non-Hodgkin Lymphoma
Item
patients with histologically documented (by the nih pathology department) solid tumors and lymphoid malignancies (lymphoma and cll) who are refractory to standard therapy or who have no acceptable standard treatment options. patients with lymphoid malignancies will be eligible if their disease has progressed following 2 standard therapies (aggressive nhl), and if their disease is considered refractory (for indolent nhl).
boolean
C0280100 (UMLS CUI [1])
C0746336 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0023434 (UMLS CUI [4])
C0205269 (UMLS CUI [5,1])
C2936643 (UMLS CUI [5,2])
C2936643 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0242656 (UMLS CUI [7,1])
C0687676 (UMLS CUI [7,2])
C2936643 (UMLS CUI [7,3])
C1265611 (UMLS CUI [7,4])
C1332225 (UMLS CUI [8])
C1514815 (UMLS CUI [9])
C1334170 (UMLS CUI [10])
Measurable Disease | Evaluable Disease
Item
patients must have measurable or evaluable disease.
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Patient recovered Toxicity CTCAE Grades | Toxicity Due to Adverse event | Toxicity Due to Prior Chemotherapy | Toxicity Due to Biological treatment | Nitrosourea | Mitomycin | UCN 01 | Study Subject Participation Status | Investigational New Drugs | Prior radiation therapy | Major surgery | Diphosphonates Malignant Neoplasms | Antiandrogen therapy Prostate carcinoma
Item
patients must have recovered to at least grade less than or equal to1 toxicity levels due to adverse events and/or toxicity of prior chemotherapy or biologic therapy. they must not have had chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin c, or ucn-01). patients must be greater than or equal to 2 weeks since any prior administration of study drug in an exploratory ind/phase zero study. patients must be greater than or equal to 1 month since any prior radiation or major surgery. however, patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy.
boolean
C1115804 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0877248 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C1514457 (UMLS CUI [3,3])
C0600688 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C1531518 (UMLS CUI [4,3])
C0028210 (UMLS CUI [5])
C0002475 (UMLS CUI [6])
C0950721 (UMLS CUI [7])
C2348568 (UMLS CUI [8])
C0013230 (UMLS CUI [9])
C0279134 (UMLS CUI [10])
C0679637 (UMLS CUI [11])
C0012544 (UMLS CUI [12,1])
C0006826 (UMLS CUI [12,2])
C0279492 (UMLS CUI [13,1])
C0600139 (UMLS CUI [13,2])
Age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
the eastern cooperative oncology group (ecog) performance status less than or equal to 2 (karnofsky greater than or equal to 60%).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
life expectancy greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have normal or adequate organ and marrow function as defined below:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absolute neutrophil count
Item
absolute neutrophil count greater than or equal to 1,500/milliliter
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets greater than or equal to 100,000/milliliter
boolean
C0032181 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin* within less than or equal to 1.5 times upper limit of normal
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast (sgot)/alt (sgpt) less than or equal to 2.5 times institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
creatinine less than 1.5 times upper limit of normal
boolean
C0201976 (UMLS CUI [1])
Creatinine clearance measurement | Serum creatinine raised
Item
creatinine clearance greater than or equal to 60 ml/min (measured) for patients with creatinine levels greater than or equal to 1.5 times upper limit of normal.
boolean
C0373595 (UMLS CUI [1])
C0700225 (UMLS CUI [2])
Gilbert Disease | Serum total bilirubin measurement
Item
*we will allow patients with gilbert's syndrome with total bilirubin up to 2.5 mg/dl
boolean
C0017551 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Pregnancy test negative
Item
the effects of snx-5422 on the developing human fetus are unknown. for this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry, for the duration of study participation, and for 2 months after discontinuation from the study. women of childbearing potential must have a negative pregnancy test in order to be eligible. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with snx-5422, breastfeeding should be discontinued if the mother is treated with snx-5422.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0427780 (UMLS CUI [6,2])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs | Metastatic malignant neoplasm to brain Symptomatic | Prognosis bad | Development Frequently Progressive neurologic dysfunction | Interference Evaluation Neurological event | Interference Evaluation Adverse event
Item
patients receiving any other investigational agents. patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. however, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the principal investigator.
boolean
C0013230 (UMLS CUI [1])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0278252 (UMLS CUI [3])
C0243107 (UMLS CUI [4,1])
C0332183 (UMLS CUI [4,2])
C4013375 (UMLS CUI [4,3])
C0521102 (UMLS CUI [5,1])
C1261322 (UMLS CUI [5,2])
C1320718 (UMLS CUI [5,3])
C0521102 (UMLS CUI [6,1])
C1261322 (UMLS CUI [6,2])
C0877248 (UMLS CUI [6,3])
Illness Uncontrolled | Symptomatic congestive heart failure American Heart Association Class | Symptomatic congestive heart failure Uncontrolled American Heart Association Class | Uncontrolled hypertension | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
Item
uncontrolled medical illness including, but not limited to, ongoing or uncontrolled, symptomatic congestive heart failure (aha class ii or worse), uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0742758 (UMLS CUI [2,1])
C0002458 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C0742758 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0002458 (UMLS CUI [3,3])
C0456387 (UMLS CUI [3,4])
C1868885 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0003811 (UMLS CUI [6])
C0004936 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0525058 (UMLS CUI [8,2])
C0439801 (UMLS CUI [8,3])
Antiretroviral therapy HIV Seropositivity | Pharmacokinetic interaction SNX-5422 | HIV Seropositivity | Risk Due to SNX-5422
Item
hiv-positive patients receiving combination antiretroviral therapy are excluded from the study because of possible pk interactions with snx-5422. hiv positive patients not receiving antiretroviral therapy are excluded due to the possibility that snx-5422 may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to snx-5422.
boolean
C1963724 (UMLS CUI [1,1])
C0019699 (UMLS CUI [1,2])
C1868980 (UMLS CUI [2,1])
C3253587 (UMLS CUI [2,2])
C0019699 (UMLS CUI [3])
C0035647 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C3253587 (UMLS CUI [4,3])
Chronic diarrhea
Item
chronic diarrhea.
boolean
C0401151 (UMLS CUI [1])
Gastrointestinal Diseases Affecting Drug absorption | Postoperative state | Gastric Bypass
Item
gastrointestinal diseases that could affect drug absorption, including postsurgical states such as gastric bypass.
boolean
C0017178 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0678745 (UMLS CUI [1,3])
C0231287 (UMLS CUI [2])
C0017125 (UMLS CUI [3])
Gastrointestinal Diseases Changing Assessment Safety | Irritable Bowel Syndrome | Ulcerative Colitis | Crohn Disease | Hemorrhagic Proctocolitis
Item
gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, crohn's disease, or hemorrhagic coloproctitis.
boolean
C0017178 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C1516048 (UMLS CUI [1,3])
C0036043 (UMLS CUI [1,4])
C0022104 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
C0010346 (UMLS CUI [4])
C1257847 (UMLS CUI [5])
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