[c09aa8]: / clusters / final9knumclusters / clust_302.txt

Download this file

178 lines (177 with data), 24.3 kB

  1
  2
  3
  4
  5
  6
  7
  8
  9
 10
 11
 12
 13
 14
 15
 16
 17
 18
 19
 20
 21
 22
 23
 24
 25
 26
 27
 28
 29
 30
 31
 32
 33
 34
 35
 36
 37
 38
 39
 40
 41
 42
 43
 44
 45
 46
 47
 48
 49
 50
 51
 52
 53
 54
 55
 56
 57
 58
 59
 60
 61
 62
 63
 64
 65
 66
 67
 68
 69
 70
 71
 72
 73
 74
 75
 76
 77
 78
 79
 80
 81
 82
 83
 84
 85
 86
 87
 88
 89
 90
 91
 92
 93
 94
 95
 96
 97
 98
 99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
Patients previously treated with CVA21.
Patients treated with prior interleukin-2 (IL-2).
Patients who have been previously treated with a toll-like receptor (TLR) agonist (excluding topical agents) and patients who have received experimental cancer vaccines.
Patients must not have been previously treated with lorlatinib.
Subject who has been previously treated with an anti-CCR4 antibody or an IDO1 inhibitor;
Serum erythropoietin level of > 500 mU/mL in subjects not previously treated with an ESA.
For Group A: Subjects with a history of brain metastases are ineligible. This includes previously treated brain metastases. For Group B (subjects with AML): Active symptomatic CNS involvement of AML. Subjects with previously treated leptomeningeal disease that has been effectively treated are eligible.
Subjects previously treated with any anti-PD-L1 antibody are eligible for study participation).
Patient previously treated with a dose of imatinib > 400mg
The majority of the anticipated target volume (> 50%) must have been previously treated to >= 40 Gy; prior radiation therapy (RT) must have been completed > 6 months prior to initiation of IMRT reirradiation; if previous RT records are unavailable, investigators can estimate the dose to previously treated tissues based on completion notes or other treatment history
Subjects with prior organ transplant or being treated, or anticipated to be treated, with cyclosporine (because long-term administration of the combination of cyclosporine and sirolimus is associated with deterioration of renal function).
Previously treated with an anti-DKK1 therapy
Has been previously treated with an Indoleamine-2,3-dioxygenase-1 (IDO1) inhibitor (e.g., epacadostat, BMS-986205)
AML that transformed from previously treated myelodysplastic syndromes
Patients previously treated with any intra-arterial regional hepatic therapy such as trans-arterial chemoembolization.
Previously treated with pacritinib
Recurrent malignant gliomas previously treated with radiotherapy and/or chemotherapy
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
A washout period of 6-weeks for patients treated last with platinum based chemotherapy. A 2-week washout period for patients treated with all other therapies.
Previously treated with anti-pCAD biologic therapies.
Subjects treated with pemetrexed (pemetrexed disodium) previously will be eligible only if 8 weeks have elapsed between the last dose of pemetrexed and the date of surgery
Patients previously treated on clinical trial with reolysin
Patients must not have been previously treated with chemotherapy or radiation for diagnosis of lymphoma; brief (< 15 days) treatment with glucocorticoids is acceptable
Patients treated with prior Interleukin-2 will be allowed to be in this study
Previously treated in situ carcinoma (i.e., noninvasive)
MCL has been previously treated and has relapsed after or progressed during prior therapy.
Patients who have previously been treated with any of the agents or same class of agents they are scheduled to receive will be excluded. For example, a patient previously treated with a PD1 or PDL1-based therapy will not be eligible for avelumab+4-1BB or avelumab+OX40 arms. A patient previously treated with an OX40 based therapy will not be eligible for any of the OX40 single-agent or combination arms.
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Pathologically confirmed NSCLC, not previously treated, with a plan to undergo surgery
Pathologically confirmed SCCHN, not previously treated, with a plan to undergo surgery
Patients must be immunotherapy-naive. Those who have previously been treated with conventional chemotherapy for a prior history of sarcoma in the adjuvant setting may be included.
Patients who have previously been treated with talimogene laherparepvec, any other oncolytic virus or pelvic radiation are ineligible
Patients that have previously been treated with daratumumab or ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Phase II Exclusion Criterion Only: Patients previously treated with whole brain radiation therapy (WBRT)
Acute myeloblastic leukemia (AML) that was previously treated with HMA and is unfit for intensive chemotherapy\r\n* Patient must be within 6 months of prior treatment with HMA and must be willing to be treated with the same agent on this study
Subject previously treated with blinatumomab.
Patients previously treated with regorafenib, lonsurf or capecitabine as the last prior regimen can start on this study as long as there is at least 1 week of period between the last dose of previous treatment and day 1 in this study provided the patients are eligible; patients who were on FOLFOX or FOLFIRI regimens must have at least 2 weeks period between the last dose and the first dose in this clinical study; patients previously treated with Avastin, Zaltrap, cetuximab, pembrolizumab, panitumumab, nivolumab Erbitux, and Vectibix must have at least 4 weeks period between the last dose of previous chemotherapy and the first dose in this clinical study
Previously treated with a maximum of 4 cancer-directed treatment regimens.
All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
Previously untreated or treated subjects with no limit on prior lines of systemic therapies are allowed
Has previously been treated with axitinib, AGS-16C3F, or AGS-16M8F
Patients who have previously been treated with avelumab (or another PD1/PDL1 inhibitor) in combination with 5-azacytidine will be excluded
Patients cannot have previously been treated with interferons (e.g., for chronic active hepatitis)
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Patients who have been previously treated for metastatic melanoma may be included (e.g. prior treatment with v-raf murine sarcoma viral oncogene homolog B [BRAF] inhibitors and/or ipilimumab will be allowed), provided that they have had a three week ‘washout’ prior to signing consent and have not been treated with a PD-1 blocking antibody
Subjects previously treated with CVA21.
Patients with disease only in the bone previously treated with radium-223 will not be eligible
Patients with MDS (up to 20% blasts) of any risk as defined as:\r\n* Previously untreated\r\n* Previously treated with hypomethylating agent (HMA) agent; patients need to have relapsed or progressed after any number of cycles of HMA therapy; patients that do not respond to HMA therapy will also be allowed in the study; relapse or progression will be measured by International Working Group (IWG) 2006 criteria; no response will be lack of clinical benefit after at least 6 cycles of HMA therapy
Patients previously treated with alectinib (Note: this only applies to the phase II portion of the study; participants entering the phase I portion of the study will still be eligible if previously treated with alectinib)
Patients with histologically or cytologically documented, unresectable, Stage IV transitional cell carcinoma of the urothelium who have not been previously treated with first-line chemotherapy.
Patients previously treated with immunotherapy, targeted therapy, or no therapy (treatment naive) will be eligible
NOTE: There is no exclusion for prior immune-based therapy; this includes patients previously treated on Arms 1 or 2 who are otherwise eligible for treatment on Arm 3 or 4
Patients who have previously been treated with nivolumab and/or ipilimumab in combination with 5-azacytidine will be excluded
Patients who have previously been treated with systemic sonidegib or with other Hedgehog (Hh) pathway inhibitors
Patients who have previously been treated with systemic LDE225 or with other hedgehog pathway inhibitors
In the phase II portion of the study, patients that have been previously treated with any systemic therapy for GIST are not permitted to enroll, with the exception of adjuvant imatinib systemic therapy or exposure to imatinib within 4 weeks of signing consent
Patients previously treated with immunotherapy, targeted therapy, or no therapy (treatment naive) will be eligible (Turnstile I)
Patients being treated with certain drugs not acceptable while receiving CFI-400945 fumarate.
Patients who have been treated with vemurafenib will be allowed in this study
Actively being treated on any other therapeutic research study
The subject has previously been treated for the primary diagnosis of OP-SCCA or SG-SCCA
Patients treated with biologics within a specific timeframe
Patients previously treated with RUX or AZA (only applicable for the MF and MDS/MPN arms)
Previously treated participants
Patients previously treated with immunotherapy, targeted therapy, or no therapy will be eligible; patients receiving cytotoxic agents will be evaluated by the PI or his designee
Patients may not have previously been treated with > 1 course of radiotherapy to the brain
Patients may not have previously been treated with radiosurgery to the brain
Actively being treated on any other therapeutic research study
Patients that have previously been treated with ixazomib, or who participated in a blinded study with ixazomib (whether treated with ixazomib or not)
Previously treated in-situ carcinoma (ie, noninvasive)
Patients may have had any number of prior treatment regimens (including biologic) before or after radiotherapy; patients may not have previously been treated with bevacizumab or lapatinib. Gliadel wafers must be approved by CERN Principal Investigator (PI) (Project Leader, Co-Leader and Protocol PI)
Actively being treated on any other therapeutic research study
Actively being treated on any other therapeutic research study
Actively being treated on any other research study
Patients previously treated with immunotherapy, targeted therapy, or no therapy will be eligible; patients receiving cytotoxic agents will be evaluated by the PI or his designee as to suitable eligibility (Turnstile I)
Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at the 50 mCi dose; neuroblastoma patients can be treated at the 50 mCi dose with or without stored stem cells
Previously untreated and treated patients are eligible
Patients previously treated with TLR-7/8 agonist treatment.
Treated with hydroxyurea within 30 days;
Previously treated ALL including philadelphia chromosome (BCR-Ab1) positive ALL who meet all of the following criteria: \r\n* Diagnosis of CD19-positive B-cell ALL based on the flow cytometry and histology \r\n* Previously treated subjects with primary refractory disease OR after first or subsequent relapse \r\n* Subjects with detectable lymphoblasts in bone marrow (BM) or extramedullary disease (EMD) that is radiographically measurable and amenable to repeat biopsies
Women treated previously with 5-fluorouracil or imiquimod or other medications for high-grade squamous intraepithelial lesions will be excluded from the study
Group 2 - patients must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET rearrangement that was not previously treated with a TKI that inhibits RET.
Patients who have been previously treated with inotuzumab ozogamicin
Patients who have previously been treated with eribulin are allowed to participate in the microdialysis portion of the study only
Patients who have previously been treated with whole brain radiation
Patients may be treatment-naive or may have been previously treated for metastatic disease
Treatment-naïve and previously treated patients will be included; however, patients may not have received a BRAF or HSP90 inhibitor in the past
Subjects previously treated with BRAF or HSP90 inhibitor therapy
Subject has been previously treated with LifeSeal™ Surgical Sealant.
Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment;\r\n* NOTE: patient with < 6 moths of life expectancy will be treated with palliative QUAD shot radiotherapy and those with > 6 moths of life expectancy will be treated with conventionally fractionated full dose re-irradiation approach; additional other factors determining which patients will be treated with Quad shot therapy rather than full dose are if the patients have poor performance status, bulky or diffuse disease, significant medical co-morbidities, and significant metastatic disease burden
Subject has been previously treated with mogamulizumab;
Subject must not have been treated previously with talimogene laherparepvec or tumor vaccine.
Without confirmed stability over 60 days in patients previously treated with prior surgery or radiation; OR
Participants previously treated in the recurrent/metastatic setting with any 1 of the 3 SOC therapies in this study (i.e., docetaxel, capecitabine, or gemcitabine) may not receive the same therapy if randomized to the SOC arm. Additionally, participants previously treated in the recurrent/metastatic setting with all 3 SOC therapies are excluded from this study.
were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN)
Patients must have been previously treated with a taxane except in cases of contraindication (e.g. poor performance status, age or patient choice)
Patients who have previously been treated with cytotoxic chemotherapy; however, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study
Subject who was previously treated with at least one prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy.
Patients must have been previously treated, as defined by treatment with at least one prior cytotoxic regimen or agent
Patients treated with TNF antagonists.
Has been previously treated with a Bromodomain and Extra-Terminal (BET) inhibitor
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Patients who have been previously treated in the adjuvant setting for melanoma will be eligible for treatment after a 28 day wash-out period
Previously treated with an anti-Dkk-1 therapy.
Patients are to be treated with hypofractionated RT
Patients must be ipilimumab-eligible. (This includes: 1) patients previously untreated with ipilimumab; 2) patients previously treated (more than 1 year previously) with ipilimumab using a route of administration other than intravenous infusion; and 3) patients previously treated with antitumor agents other than intravenous ipilimumab).
Patients who were previously treated with ipilimumab administered by intravenous infusion.
History of previously treated smoldering myeloma
Untreated or previously treated for Waldenström's macroglobulinemia. Previously treated subjects must have either documented disease progression or had no response (stable disease) to the most recent treatment regimen.
Currently or previously treated with ruxolitinib for PMF or Post-PV/ET MF for at least 28 days, and characterized by
Cholangiocarcinoma subjects must have radiographically measurable disease in at least one site not previously treated with radiation, chemoembolization, radioembolization, or other local ablative procedures; a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable.
Subjects must have radiographically measurable disease in at least one site not previously treated with radiation, chemoembolization, radioembolization, or other local ablative procedures; a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a radiologist, is acceptable.
Patients who have not previously been treated with HMA therapy will be excluded
Participants previously treated with bendamustine only if their duration of response was >/= 24 months
Prior malignancy except previously diagnosed and definitively treated more than 3 years prior to trial or whose prognosis is deemed good enough to not warrant surveillance
BCC/SCC that was previously treated (i.e., recurrent BCC/SCC)
Patients who have been previously treated with bendamustine plus rituximab (BR) are eligible, provided they did not progress during or within 6 months of completing BR treatment
Previously treated SCLC with only one prior treatment regimen (cyclophosphamide/doxorubicin/vincristine [CAV] alternating with etoposide/cisplatin [EP] is acceptable)
Treated with at least 1 year of imatinib
Prior therapy allowed: \r\n* Patients may have been previously treated with up to three regimens of oral multikinase inhibitors, including sorafenib, sunitinib and pazopanib\r\n* Patients may have been previously treated with external beam radiation or cytotoxic chemotherapy therapy
Patients may not have been treated with prior sipuleucel-T
Currently or previously treated with AMG 386, or other molecules that inhibit the angiopoietins or Tie2 receptor
Patients previously treated with radiation therapy to the thoracic or lumbar spinal levels of involved disease will not be included
Previously treated with ponatinib
Indications B - LMS: Subjects previously treated with at least one prior line of approved therapy.
Previously treated with a maximum of four unique chemotherapy containing treatment regimens
RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
Patients previously treated with eculizumab for TAM.
Previously enrolled and treated for at least 9 months in Study NEOD001-001
Herceptin: women who have been previously treated with Herceptin or other monoclonal antibody therapies are eligible for the trial
Currently or previously treated with biologic, or immunotherapy
Previously-treated with any conditioning regimen and any GVHD immune suppression prophylaxis and formulation of steroids, except as noted in Exclusion Criteria #2.
Planned to be treated by active surveillance
Patients who have previously been treated with IMGN901
Patients must be untreated or have had only one prior chemotherapy regimen for ALL or LL; previously treated patients will be analyzed separately
Being treated with anti-TNF therapies or has been treated with an anti-TNF therapy within 5 half-lives of randomization.
Currently or previously treated with biologic, small molecule, immunotherapy, chemotherapy, or other agents for metastatic pancreatic carcinoma
Patients previously treated with sunitinib or crizotinib
Tumor must not have been treated previously with radiation
Subjects previously treated on another investigational agent must have a 2-week or more washout before starting cabozantinib, depending on the agent, toxicity profile, and half-life; however, such patients may begin tetracycline dosing after consent is signed
Subjects previously treated with a systemic photosensitizer within 4 months of screening date
Not previously treated with prior anti-cancer therapy for FL
Prior treatment with sirolimus, cyclophosphamide or topotecan: patients previously treated with any of these drugs as single agents will be eligible for this study; patients previously treated with two of the three drugs will also be eligible, however patients previously treated with all three agents in combination will not be eligible; patients previously treated with sirolimus analogues (e.g. temsirolimus, everolimus, or ridaforolimus) are also eligible
The patients may start any Food and Drug Administration (FDA) approved endocrine therapy (with which they have not been previously treated) at week 4 of the trial except for tamoxifen
Patients who have previously been treated with LDE225 or other hedgehog (Hh) pathway inhibitors
Subjects who had been treated with ADI-PEG 20 previously.
Subjects that have previously been treated with a veliparib.
Previously treated; NOTE: no limit to prior therapy provided there is adequate residual organ function
Progressive disease if treated with chemotherapy, radiotherapy, surgery or immunotherapy. If prior radiation was given, the measurable disease should be outside the radiation port. Unequivocal progression of HCC/BTC lesions previously treated with catheter-based therapy including transarterial chemoembolization or radioembolization is allowed.
Subjects who had been treated with ADI-PEG 20 previously.
Patients previously treated with systemic chemotherapy will be eligible
Patients who have previously been treated with systemic LDE225 or with other Hh pathway inhibitors
Maintenance of Lupron or antagonist unless previously treated with orchiectomy
Subjects that have previously been treated with dacarbazine or its analogue temozolomide or eribulin.
If previously treated with bortezomib (alone or in combination), progression during treatment
If previously treated with a lenalidomide and dexamethasone (len/dex) combination:
Patients diagnosed with alcoholism may not be treated with disulfiram
Has been treated with mastectomy
Patients previously treated with radioactive isotope (e.g. strontium [Sr]89) within 30 days of randomization
Patients previously treated with anti-GITR therapy.
Women who will be treated at the Johns Hopkins Hospital, Sibley Memorial Hospital or who will be treated by oncologists in the community as long as we will have access to treatment records
All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
Parents of childhood cancer survivors who are now 18 years or older and who were previously treated for ALL or AML (do not need to live with the child)
Patients may have been previously treated or previously untreated
Patients will receive repeated cycles of identical chemotherapy that will likely result in grades III-IV hematological toxicity; patients will be treated outside of Children’s Oncology Group (COG) protocols with specific requirements for schedule of G-CSF administration; the following categories of patients treated at Children’s Hospital of Michigan are eligible for this study:\r\n* Patients with brain tumors treated according to modified Head Start II protocol with vincristine, etoposide, cyclophosphamide, and cisplatin (OPEC) chemotherapy;\r\n* Patients with recurrent Hodgkin lymphoma treated with ICE (ifosfamide, carboplatin, etoposide) chemotherapy;\r\n* Patients with recurrent solid tumors including sarcomas, Wilms’ tumor, neuroblastomas, or brain tumors treated with high dose ICE or ICT (ifosfamide, carboplatin, topotecan) chemotherapy
Patients who have previously been treated with systemic LDE225 or with other Hedgehog (Hh) pathway inhibitors
Will be treated according to the Armstrong method
Cancer patients without BRONJ who have been treated with intravenous zoledronate for >= 1 year duration
Subject is diagnosed with neuroblastoma, hepatoblastoma, osteosarcoma or extracranial germ cell tumors and has not been previously treated with cisplatin or carboplatin.
Liver nodule previously treated with trans-arterial or thermal ablation
Patients who have been or are anticipated to be treated with radiosurgery
Previously treated with any prior mIDH1 targeted therapy
Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not
Tumor previously treated with radiation therapy
Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.