Resolution of all acute AEs resulting from prior cancer therapies to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) grade ? 1 or to that patient's pre-study baseline (except alopecia or neuropathy)
Any pre-existing medical condition that would represent toxicity in excess of grade 1 as measured by CTCAE (National Cancer Institute [NCI] Common Toxicity Criteria for Adverse Events version 4.03) unless the symptom is not considered medically significant by the treating investigator (e.g., alopecia)
Recovered from all toxicities associated with prior treatment, to acceptable baseline status or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4, grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligo
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicities see below limits for inclusion) or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (eg, alopecia or vitiligo).
Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade less than or equal to (</=) 2 (according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) prior to Day 1 of Cycle 1
National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grade 3 or higher toxicities due to any prior therapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to ?Grade 1, as determined by National Cancer Institute Common Toxicity Criteria for Adverse Effects (CTCAE) v 4.0 (http://evs.nci.nih.gov/ftp1/CTCAE/About.html).
For patients with newly diagnosed ovarian/tubal/peritoneal cancer who have received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following:\r\n* Decline in serum cancer antigen (CA) 125 level\r\n* At least a 30% decrease in the sum of the longest diameter of target lesions on radiographic imaging\r\n* Improvement of ascites volume\r\n* Neoadjuvant chemotherapy must be held for at least 3 weeks prior to surgery\r\n* Resolution of any effects of prior therapy (except alopecia and peripheral neuropathy) to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) grade =< 1 and to baseline laboratory values as defined
At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (4 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy); any number of prior therapies for recurrent/metastatic ACC are allowed, with the exception of previous treatment with PD-1 pathway inhibitors
Not recovered from side effects of prior therapy to ? Grade 1 (according to National Cancer Institute [NCI] CTCAE version 4.03). Certain side effects that are unlikely to develop into serious or life-threatening events (e.g. alopecia) are allowed at > Grade
Any abnormality that would be scored as National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (v 3.0) grade IV toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment and/or observation only
Inadequate recovery from toxicity attributed to prior anti-cancer therapy.\r\n* With the exception of alopecia, fatigue, or peripheral neuropathy, patients must have recovered to =< grade 1 (National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] version [v] 4.03) residual toxicity prior to first dose of protocol-indicated treatment.
TREATMENT WITH SJCAR19: Has recovered from all National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade III-IV, non-hematologic acute toxicities from prior therapy
History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ? 3 drug-related CNS toxicity
Subject has not fully recovered to baseline or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ? Grade 1 from toxicity due to all prior therapies, except alopecia and other non-clinically significant AEs.
Subjects must have recovered to =< grade 1 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 or stabilized from toxicity of prior chemotherapy or biologic therapy administered more than 4 weeks or 5 half-lives earlier, whichever is shorter
Not recovered from adverse events (AE)s or toxicities due to previous treatments to a grade 1 or less specified in National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 excepting, albumin (< 2.5 g/dL), AST and ALT in patients with liver metastases (> 5 x ULN) alkaline phosphatase (ALP) in patients with bone metastases (> 5 x ULN) and alopecia
Patients may have received any number of prior lines of therapy. All prior systemic anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 4 (CTCAE version 4.0; National Cancer Institute [NCI], 2009) at the time of enrollment. This does not include alopecia and grade 1 or less peripheral neuropathy.
Presence of ? CTCAE grade 2 toxicity (except alopecia of any grade) due to prior cancer therapy, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 4.03)
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).
Recovery from toxicity from any prior therapy to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.03) to grade 1 or better (except for =< grade 2 neuropathy, alopecia, xerostomia, dysphagia, or mucositis)
Patients with ongoing toxicities > grade 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (excluding alopecia) due to prior anti-cancer therapy
All prior treatment-related toxicities must be National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4 =< Grade 1 (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be =< Grade 2]) at the time of treatment allocation.
Ongoing >= grade 3 cardiac, pulmonary, renal, gastrointestinal or hepatic toxicities according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4 toxicity criteria
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (version 4.0) grade 3 or higher toxicities due to any prior therapy (e.g. radiotherapy) (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
Have recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 grade ?1.
Receipt of 1 previous systemic drug therapy for at least 3 weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade 3 or 4 event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v4.0), less than 3 weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #3).
All prior anti-cancer treatment-related toxicities must be less than or equal to grade 1 according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE version 5.0; National Cancer Institute [NCI], 2017) at the time of enrollment; a notable exception are endocrinopathies caused by immune checkpoint inhibitors that are appropriately treated with medical management (e.g. hormone replacement therapy, anti-diabetic agents)
Patients with grade 3 toxicities or less using the Common Toxicity Criteria (version 3.0) developed by the National Cancer Institute of the United States of America (USA) (Common Terminology Criteria for Adverse Events version 3.0) related to cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.03, must be <=Grade 1 at the time of enrolment except for alopecia and Grade 2 peripheral neuropathy.
All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTCAE], Version 4.03, 2010) must be <= Grade 1 at the time of enrollment, except for alopecia and Grade 2 neuropathy.
Any > grade 1 (according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version [v.]4.03) adverse reaction unresolved from previous treatments or not readily managed and controlled with supportive care; the presence of alopecia of any grade and peripheral neuropathy ? grade 2 without pain is allowed
Patient must not have ongoing ventricular cardiac dysrhythmias of grade >= 2 as described by the Cancer Therapy Evaluation Program (CTEP) version 4.0 of the National Cancer Institute (NCI) CTCAE
History of severe (defined as ? grade 3, using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current active minor version) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients (10 mM Tris buffered saline) in the investigational agent.
Any non-hematologic toxicity (excluding alopecia) from prior treatment that has not resolved to Grade less than or equal to (<=) 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.0) at screening
At least 14 days since the end of prior systemic VEGF-targeted treatment (ie, sunitinib, pazopanib, axitinib, or sorafenib), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity (except alopecia and hypothyroidism) either to Grade 0 or 1 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.03) or to baseline.
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).
National cancer institute common terminology criteria for adverse events (NCI CTCAE) (version 4.0) Grade 3 or higher toxicities due to any prior therapy (e.g., radiotherapy) (excluding alopecia)
Recovered from all toxicities associated with prior treatment to acceptable baseline status (for laboratory toxicity see below limits for inclusion) or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.03, Grade of 0 or 1, except for toxicities not considered a safety risk (e.g., alopecia or vitiligo).
At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab-containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowed
All prior treatment- related toxicities must be National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03 <=Grade 1 (except alopecia [permissible at any Grade] and peripheral neuropathy [which must be <= Grade 2]) at the time of treatment allocation.
At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens) or radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism); any number of prior therapies for recurrent/metastatic ACC are allowed
Recovered from toxicities related to prior anticancer therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, v4.0) grade ?2.
Has not recovered (recovery is defined as National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE version (v)4.03] grade =< 1) from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting the inclusion requirements stated in the inclusion criterion
Subjects who have not recovered from toxicities as a result of prior anticancer therapy to less than Grade 2 severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0, except alopecia and infertility.
Resolution of chemotherapy and radiation therapy related toxicities to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 1 or lower severity, except for diarrhea (which must be Grade 0 without a supportive antidiarrheal medications) and alopecia (any grade)
Prior anti-cancer treatment related toxicities except alopecia and lab values as outlined above must be =< grade 1 as per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4
Unresolved toxicity higher than CTCAE grade 1 (NCI-CTC version 4.0) attributed to any prior therapy/procedure excluding alopecia. (NCI: National Cancer Institute)
Has recovered from all acute National Cancer Institute (NCI) Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the principal investigator (PI)
History of persistent Grade 2 or higher hematological toxicity according to National Cancer Institute-Common Toxicity Criteria Version 4.0
Resolution of any pre-existing toxicity from prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 =< grade 1 except neuropathy (=< grade 2) and tinnitus (=< grade 2), and hearing loss (=< grade 4)
At least 2 weeks must have elapsed since the end of prior systemic treatment and/or 4 weeks since completion of radiotherapy with resolution of all treatment-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 grade =< 1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism) prior to starting study drug treatment; any number of prior therapies for recurrent/metastatic salivary gland cancer are allowed
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia)
Has persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia). Stable sensory neuropathy ? grade 2 National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 is accepted
Patients must have recovered from toxicity related to prior therapy (chemotherapy, surgery or radiation) to grade =< 1 (defined by Common Terminology Criteria for Adverse Events [CTCAE]); the National Cancer Institute (NCI) CTCAE version 4 will be used for toxicity and adverse event reporting
Patients with baseline neurologic symptoms at National Cancer Institute (NCI) Common Toxicity Criteria (CTC) level 3 are not eligible
Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] grade ? 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
Has recovered from all acute National Cancer Institute (NCI) Common Toxicity Criteria grade II-IV non-hematologic toxicities from prior therapy per the judgment of the principal investigator (PI)
Acute toxicities from any prior treatment, surgery, or radiotherapy must be National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade less than or equal to (<=) 1
Subject must have recovered from the effects of prior systemic antineoplastic or radiation therapy(s) to ? Grade 1 (National Cancer Institute - Common Terminology Criteria for Adverse Events [NCI-CTCAE], Version 4.0) severity or to subject's baseline values, excluding alopecia.
Prior treatment toxicities (i.e. any toxicity from treatment of a previous cancer ) must be resolved to =< grade 1 according to National Cancer Institute (NCI) CTCAE version 4.0 (except alopecia)
Active, clinically serious infections defined as ?Grade 2 according to NCI Common Toxicity Criteria for Adverse Effects (CTCAE), version 4.0
History of severe (using the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 4.0 [NCI-CTCAE] v4 current minor version ? grade 3) allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or excipients
The subject has not recovered from toxicity due to prior therapy to Baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). Residual chemotherapy-induced neuropathy grade less than equal to (<=) 2 is permitted.
PART II: Utilizing the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 4, values for the following laboratory tests should be no more than grade two levels: ANC, hemoglobin, platelet count, total bilirubin, creatinine, transaminase (AST/ALT), PT, PTT, urine uric acid, urine pH, urine oxalate
History of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria [NCI-CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Prior chemotherapy and/or radiation are allowed; at least 3 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for mitomycin-C and nitrosoureas); and recovered from all treatment related toxicity to =< grade 1 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (with the exception of alopecia and radiation-induced taste changes); prior temozolomide treatment is not restricted
Any vomiting, retching or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea 24 hours preceding chemotherapy
Any vomiting, retching, or National Cancer Institute (NCI) Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours(hrs.) preceding radiation and chemotherapy
Normal electrocardiogram (ECG), laboratory values (chemistry, complete blood count) and urinalysis, as judged Grade 0-1 by per National Cancer Institute Common Toxicity Criteria (NCI-CTC)
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events, version 4) must be <=Grade 1 at the time of enrollment except for alopecia, and grade 2 neuropathy.