History of reversible posterior leukoencephalopathy syndrome (RPLS)
Trisomy 21 (Down syndrome)
Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
Patients with Down syndrome
Patients with Down syndrome are not eligible
Down syndrome
Patients with down syndrome are excluded from this study
Patients with known symptomatic Fanconi anemia (FA), ataxia-telangiectasia (A-T) syndrome, Bloom syndrome (BS) and Nijmegen breakage syndrome (NBS) are not eligible (asymptomatic carriers are acceptable)
Mycosis fungoide/Sezary syndrome
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
History of nephrotic syndrome
Patients with nevoid BCC syndrome (Gorlin syndrome) should not enroll in this study
Any history of serotonin syndrome (SS) after receiving 1 or more serotonergic drugs
Patients with Down’s syndrome
Patients with Down syndrome
Erythema multiforme, toxic epidermal necrolysis, or Stevens-Johnson syndrome
History of multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome)
Any history of serotonin syndrome after receiving serotonergic drugs
Documented history of carcinoid syndrome
Subjects with history of or active symptoms of carcinoid syndrome
Any history of serotonin syndrome (SS) after receiving serotonergic drugs
Known reversible posterior leukoencephalopathy syndrome (RPLS)
History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
History of Gilbert’s syndrome
Any history of serotonin syndrome (SS) after receiving serotonergic drugs
Has any history of serotonin syndrome after receiving 1 or more serotonergic drugs
Has history of reversible posterior leukoencephalopathy syndrome
Has a paraneoplastic syndrome other than syndrome of inappropriate antidiuretic hormone secretion (SIADH) (hyponatremia)
Known Gilbert’s syndrome
history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome;
Down syndrome
Individuals with Down syndrome
History of serotonergic syndrome
Any history of Stevens-Johnson syndrome
Patients with an inherited cancer syndrome or a medical history suggestive of an inherited cancer syndrome remain eligible
Patients with known Gilbert’s syndrome
Subjects with Gorlin syndrome
Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
No history of Steven’s Johnson’s syndrome, toxic epidermal necrolysis (TEN)s syndrome, or motor neuropathy
RANDOMIZED PHASE II (ARMS K AND L): No history of Steven’s Johnson’s syndrome, TENs syndrome, or motor neuropathy
History of Gilbert’s syndrome
Acute IA defined as duration of clinical syndrome of <30 days.
History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
Patients with HNPCC (Lynch Syndrome)
Has any history of serotonin syndrome after receiving serotonergic drugs
Down syndrome
Kostmann syndrome
Shwachman syndrome
No known Gilbert’s syndrome or known homozygosity for UGAT1A1*28 polymorphism
Patient has a history of Stevens-Johnson-Syndrome (SJS) or Toxic Epidermal Necroloysis (TEN)
Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome
Documented Gilbert’s syndrome
Diagnosis of Down syndrome (Trisomy 21)
History of Gilbert’s syndrome
Patients with any of the following diagnoses:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)
Patients with Li Fraumeni syndrome are excluded from the study
Radiosensitivity syndrome (scleroderma, dermatomyositis, other genetic syndrome that predisposes to adverse radiotherapy complications)
Patients with a family history or Li-Fraumeni syndrome will not be eligible
History of posterior reversible encephalopathy syndrome
Patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other inherited bone marrow failure syndromes are not eligible
Patients who have experienced bowel perforation, neurologic involvement, Guillain Barré syndrome, Myasthenia Gravis, Steven Johnson syndrome and other intractable events or grade 4 non-laboratory toxicity
Patients with a history of toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome are excluded
Subject has Down syndrome.
Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
Subjects who have history of toxic epidermal necrolysis or Stevens-Johnson syndrome;
Had prior serotonin syndrome
Patients with concomitant genetic syndrome: such as patients with Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down Syndrome will not be excluded.
Patients must not have known Gilbert’s syndrome
Known history or presence of Sweet Syndrome at screening
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
History of posterior reversible encephalopathy syndrome.
No history of erythema multiforme, toxic epidermal necrolysis or Stevens-Johnson syndrome
Any history of serotonin syndrome after receiving serotonergic drugs.
Have ongoing or recent (?6 months) hepatorenal syndrome.
Patients who have a known inherited syndrome as the cause for hormone over secretion.
History of Osler-Weber-Rendu syndrome or hereditary hemorrhagic telangiectasia
Known to have a hypercoagulability syndrome (e.g.: antithrombin III, deficiency, anticardiolipin syndrome etc)
Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible
History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome
Cushing’s syndrome
Li-Fraumeni Syndrome
History of reversible posterior leukoencephalopathy syndrome (RPLS)
History of Gilbert’s syndrome
Down Syndrome
History of Gilbert’s syndrome
History of Gilbert’s syndrome
Individuals with Down syndrome
History of Gilbert’s syndrome
Carcinoid Syndrome
Has a known history of, or active, neurologic paraneoplastic syndrome
Nephrotic syndrome
Down syndrome
Kostmann syndrome
Shwachman syndrome
Patients with Down syndrome and deoxyribonucleic acid (DNA) fragility syndromes (such as Fanconi anemia, Bloom syndrome) are excluded
Concomitant genetic syndrome or other known bone marrow failure syndrome
Down syndrome
Patients with Down syndrome are excluded.
Patients with nevoid BCC syndrome (Gorlin syndrome) may enroll in this study but must meet the criteria for locally advanced or metastatic disease listed above
History of Gilbert’s syndrome
Known history of Gilbert’s syndrome
Patients with a known history of Gilbert’s syndrome
Sézary syndrome
Subjects with posterior leukoencephalopathy syndrome
History of neurological conditions that would confound assessment of treatment-emergent neuropathy other than =< grade 1 peripheral neuropathy including multiple sclerosis or other demyelinating disease and/or Eaton-Lambert syndrome (para-neoplastic syndrome); diabetes is allowed
Subjects who have Gorlin syndrome
History of hereditary hemorrhagic telangiectasia (HHT, Osler-Weber-Rendu syndrome)
Patients with a family history or Li-Fraumeni syndrome will not be eligible
Patient has Down syndrome
History of Gilbert’s syndrome
Nephrotic syndrome
Immediate family member with a known or suspected Familial Cancer Syndrome (including but not limited to hereditary breast and ovarian cancer syndrome, hereditary non-polyposis colorectal cancer syndrome and familial adenomatous polyposis).
Subject has acute chest syndrome
History of congenital platelet function defect (e.g., Bernard-Soulier syndrome, Chediak-Higashi syndrome, Glanzmann thrombasthenia, storage pool defect)
History of hepatic sinusoid obstructive syndrome (venoocculsive disease) within the prior 3 months.
Patients with a history of hereditary hemorrhagic telangiectasia (Osler-Weber-Rendu syndrome)
Patients with an immunodeficiency syndrome
Patients with any of the following diagnoses are not eligible:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome\r\n* Wilson's disease and any other disorder of copper metabolism\r\n* Juvenile myelomonocytic leukemia (JMML)
History of Gilbert’s syndrome
Patients with Down syndrome
Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes are not eligible
Known Mirizzi syndrome.
History of irritable bowel syndrome (IBS)
Delayed gastric emptying syndrome
Patients with Sjogren's syndrome
Ongoing or recent hepatorenal syndrome.
Patients with diagnosis of chronic fatigue syndrome (CFS)
Patients with a diagnosis of obesity hypoventilation syndrome
History of irritable bowel syndrome (IBS)
Diagnosed or suspected vasospastic disease such as Raynaud’s syndrome;
Myelodysplatic Syndrome
History of Guillain-Barre syndrome
History of Guillain-Barre syndrome
Have a history of Guillain-Barre syndrome (GBS)
Patients with known or suspected Gilbert’s syndrome at the time of study enrollment
Down syndrome
Subjects who have Gorlins syndrome
Diagnosis of Down's Syndrome
History of Stevens-Johnson syndrome
History of Stevens-Johnson syndrome
History of Steven’s Johnson’s syndrome, toxic epidermal necrolysis syndrome (TENs) or motor neuropathy
History of Stevens-Johnson syndrome or toxic epidermal necrolysis syndrome.
History of Guillain-Barre syndrome or Stevens-Johnson syndrome