[c09aa8]: / clusters / 9knumclustersv2 / clust_156.txt

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Waldenstroms macroglobulinemia: must have failed courses of therapy
Failed previous HSC collections or collection attempts.
Biopsy-proven advanced stage follicular lymphoma, that have failed at least two lines of therapy multi-agent chemotherapy, but responds to salvage therapy (i.e., chemosensitive disease) (timeline months prior to enrollment)
Not responding or failed treatment on AZA or decitabine (note they are also eligible if additionally they have failed another ESA after at least cycles)
Transplant eligible (as determined by referring physician) patients who have failed one prior salvage therapy or transplant ineligible (as determined by referring physician) patients who have failed one prior therapy
Patients must have failed a carboplatin-based regimen
Patients must have failed at least lines of stand therapy as outlined for the specific diseases
Patients with q- syndrome should have failed to respond to or progressed on treatment with lenalidomide, where available and indicated
Patients may be treatment-naive or have failed previous regimen of intravesical therapy
COHORT B, GROUP : PANCREATIC CANCER: Patients must have failed a minimum of one previous line of therapy for advanced disease
COHORT B, GROUP : MESOTHELIOMA: Patients must have failed a minimum of one previous line of systemic therapy for advanced disease
COHORT B, GROUP : GALLBLADDER CANCER OR CHOLANGIOCARCINOMA: Patients must have failed a minimum of one previous line of systemic therapy for advanced disease
Patients must have disease that is no longer considered responsive to available conventional modalities or treatments (failed any known standard curative or effective therapy for that disease).
For Dose Escalation, NSCLC and Ovarian Expansion Cohorts: Subject must have failed at least one prior chemotherapy regimen for metastatic disease (urothelial and bladder cancer subjects are not required to have failed prior chemotherapy regimen if considered unfit for cisplatin-based chemotherapy)
In stratum A, patients must have failed one prior systemic chemotherapy regimen; in stratum B, patients must have failed one prior systemic chemotherapy regimen, which must include cladribine/cytarabine or are not considered to be eligible for such treatment; in stratum C, Rosai Dorfman disease (RDD) patients must have failed treatment with corticosteroid; Erdheim Chester disease (ECD) patients who have confirmed BRAF VE mutation must have failed treatment with a BRAF inhibitor or are not considered to be eligible for such treatment
Patients who have failed bendamustine-based regimen previously
Disease not amenable to standard treatment (nonresectable or disease present after one or more surgeries and/or sandostatin treatment) or subject has failed existing first line chemotherapy, biologic therapy, targeted agent therapy or radiation therapy
Waldenstroms macroglobulinemia must have failed courses of therapy
Must have received at least one prior systemic therapy, and must have relapsed or progressed after, or failed to respond to any/all available effective therapy or therapies.
Diagnosis of relapsed/refractory advanced malignancies; specifically:\r\n* Patients relapsed refractory acute myeloid leukemia that have failed at least one line of prior therapy, \r\n* Patients with myelodysplastic syndrome that have failed hypomethylating agents, \r\n* Patients with myelofibrosis that have failed or are ineligible to receive ruxolitinib\r\n* Patients that have myelofibrosis on maximal tolerated doses of ruxolitinib, who are unable to discontinue ruxolitinib, are eligible if;\r\n** They have been on stable dose for month and continue to have residual symptoms, splenomegaly or inadequately controlled blood counts
Patients must have failed at least one regimen of chemo or radiation therapy; NOTE: There is no limit to the number or types of prior therapy
Pathologically confirmed PCNSL or PTL who failed or did not respond to at least line of systemic therapy
Patients who have failed nilotinib or not tolerated nilotinib in the past
Patient must have failed at least one prior therapy
Have failed prior treatment within months of consent date
Failed at least prior chemotherapy regimen for advanced NSCLC
Patients must have a confirmed recurrent/progressive brain malignancy that have failed at least one prior treatment regimen
Failed any previous front line standard of care therapy that is currently used for the patients initial diagnosis
Patients who have previously taken mebendazole as part of any experimental anti-cancer protocol, and have failed this therapy
Patients who failed to respond first line standard of care chemotherapy or chemotherapy suspended due to toxicity or other reasons
Patients with malignant solid tumors must have relapsed after or failed to respond to frontline therapy and there must be no other known curative therapies available. Patients with desmoid fibromatosis must have relapsed after or failed to respond to at least one prior line of therapy, and in the opinion of the treating physician surgical resection of the tumor must not be possible without an amputation or other surgery predicted to result in an unacceptable functional deficit.
To be eligible for Cohort , patients must have failed one prior line of systemic therapy for advanced/metastatic disease
ARM SALVAGE COHORT: Patients with AML or biphenotypic or bilineage leukemia who have failed prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapy will be eligible for Arm ;
Patients must be ineligible for, refused or having failed at least one previous salvage regimen
Have failed, or could not tolerate, other standard of care therapies
Failed at least one standard chemotherapeutic treatment for NSCLC
Patients who have failed previous hemi-thoracic platinum therapy will be ineligible (failed is having disease recurrence =< months)
Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF VE mutation positive need to have failed, refused, or be ineligible for at least lines of therapy (vemurafenib plus one other regimen)
Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF VE mutation positive need to have failed, refused, or be ineligible for at least lines of therapy (vemurafenib plus one other regimen)
Patients with GI disorders who have failed standard therapy
Patients may not have previously failed treatment with salvage temozolomide
Stage IIB-IV mycosis fungoides or Sezary syndrome, who have failed at least standard systemic therapy or are not candidates for standard therapy
Hodgkin disease: Must have received and failed frontline therapy
Patients with intermediate- or higher risk MDS who have failed therapy with a hypomethylating agent, or have failed lenalidomide therapy if harboring a q-chromosomal deletion.
failed primary induction therapy with no complete remission and for whom no other approved therapy is available, and no more than prior salvage therapy
Refractory disease, having failed available therapies
Must be appropriate candidate for experimental therapy, as determined by investigator, after available standard therapies have failed
Patients must have failed prior therapy with either a hypomethylating agent (e.g., azacytidine, decitabine) alone or in combination with other agents. Patients with abnormalities in chromosome q, should have failed either a hypomethylating agent or lenalidomide.
Failed conventional therapy for their cancer or have a malignancy for which a conventional therapy does not exist
Patients must have disease that is recurrent or refractory to standard therapy; patients must have failed front-line therapy and declined or are not candidates for autologous stem cell transplant (ASCT) or have failed prior ASCT
Failed at least prior systemic therapy
Patients must have failed platinum based therapy as well as cetuximab; if patients were found to be intolerant of standard first line systemic chemotherapy, patients are eligible to enroll to this study provided both cetuximab and cisplatin were administered prior to enrollment
Failed >= prior systemic therapies
Failed first-line chemotherapy (including systemic and local-regional therapy)
Must have prior biopsy at any time point diagnostic for confirmed MF stage IIA-IVA, and must have failed at least one standard therapy (topical or systemic); this is mandatory
Patients with known HER- overexpressing MBC must have failed at least one prior trastuzumab-containing regimen for metastatic disease.
Disease not amenable to standard treatment (nonresectable or disease present after one or more surgeries and/or sandostatin treatment) or subject has failed existing first line chemotherapy, biologic therapy, targeted agent therapy or radiation therapy
Patients with AML or biphenotypic or bilineage leukemia who have failed at least one prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapy
Patients must have failed at least one line of chemotherapy for metastatic disease.
Patients must have failed at least one prior line of systemic immune suppressive therapy for management of chronic GVHD
Failed first-line chemotherapy
Must have failed at least standard of care systemic therapy for their malignancy
For unilateral retinoblastoma\r\n* Group A eye that has failed local therapy\r\n* Group B eye that has failed local therapy\r\n* Group C eye that has failed local therapy\r\n* Group D eye\r\n* Group E eye that is not buphthalmic, is not planned for enucleation after first cycle of chemotherapy, and is in a child less than year of age
Patients who have failed previous intraperitoneal platinum therapy will be ineligible (failed is having disease recurrence =< months)
Other available therapies have failed to cure the cancer
Patient must have failed prior chemoradiation with temozolomide and any other therapies except BEV (group A), or must have failed primary chemoradiation and a BEV-incorporating treatment (group B)
Failed standard front-line therapy
Subjects who failed at least one prior therapy (BT/Len/dex)
Subjects who failed at least two prior therapy (BT/Pom/dex)
Malignancy has failed curative therapy and has no reasonable expectation of cure with available alternative salvage therapy
Subjects must have failed at least one previous chemotherapy regimen for metastatic disease if standard therapies exist
Dose Escalation phase: Patients with solid tumors (including melanoma) who have failed or are not candidates for standard therapies of for whom no approved therapy is available
The following diseases will be permitted although other diagnoses can be considered if approved by Patient Care Conference (PCC) or the participating institutions patient review committees and the principal investigators\r\n* Aggressive non-Hodgkin lymphomas (NHL) and other histologies such as diffuse large B cell NHL: not eligible for autologous HCT, not eligible for high-dose allogeneic HCT, or after failed autologous HCT\r\n* Mantle cell NHL: may be treated in first complete remission (CR); (diagnostic lumbar puncture [LP] required pre-transplant)\r\n* Low grade NHL: with < month duration of CR between courses of conventional therapy\r\n* CLL: must have either: \r\n** Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing FLU (or another nucleoside analog, e.g. -Chlorodeoxyadenosine [-CDA], pentostatin) or experience disease relapse within months after completing therapy with a regimen containing FLU (or another nucleoside analog); \r\n** Failed FLU-cyclophosphamide (CY)-Rituximab (FCR) combination chemotherapy at any time point; or \r\n** Have p deletion cytogenetic abnormality; patients should have received induction chemotherapy but could be transplanted in st CR; or\r\n** Patients with a diagnosis of CLL (or small lymphocytic lymphoma) or diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL\r\n* Hodgkin lymphoma: must have received and failed frontline therapy\r\n* Multiple myeloma: must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted\r\n* Acute myeloid leukemia (AML): must have < % marrow blasts at the time of transplant\r\n* Acute lymphocytic leukemia (ALL): must have < % marrow blasts at the time of transplant\r\n* Chronic myeloid leukemia (CML): patients in st chronic phase (CP) must have failed or be intolerant of tyrosine-kinase inhibitors (TKI); patients beyond CP will be accepted if they have < % marrow blasts at time of transplant \r\n* Myelodysplasia (MDS)/myeloproliferative syndrome (MPS): patients must have < % marrow blasts at time of transplant \r\n* Waldenstroms macroglobulinemia: must have failed courses of therapy
Patients with AML and ALL should have received at least prior treatment regimen and either failed to achieve response or relapsed on treatment
Subjects must have a pathologic diagnosis of advanced or recurrent endometrial adenocarcinoma and must have failed at least prior line of standard chemotherapy
Patients with cutaneous T-cell lymphomas (e.g. mycosis fungoides, Sezary syndrome) must have:\r\n* Stage III or greater disease\r\n* Disease which has progressed on or failed to respond to at least therapies including one systemic therapy
Failed at least one prior chemotherapy
Stage IIB-IV mycosis fungoides and Sezary syndrome who have failed at least one standard systemic therapy or are not candidates for standard therapy; (pathology should be reviewed and diagnosis confirmed at Thomas Jefferson University Sidney Kimmel Cancer Center)
Subjects should have received and failed at least one prior cytotoxic chemotherapy regimen for advanced disease that included trastuzumab
Subject has attempted \best\ medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
NSCLC that has failed crizotinib treatment
Participants who have failed at least one line of systemic therapy for advanced stage HCC or participants who are ineligible or unable to tolerate the standard of care treatment.
Relapsed or refractory disease (Stage III or IV): NSCLC or pancreatic cancer must have failed at least prior treatment. Breast cancer must have failed at least prior treatments.
Patients must have failed one prior line of CT-based therapy for unresectable disease
Patients who have failed at least systemic chemotherapy regimen for metastatic disease, but not more than regimens
Received and failed all known effective therapies for their disease;
Patients may have failed ablative therapy
Participants with HL must be in their second of later relapse, have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell transplant
Failed previous antifungal therapy or expected to live < days.
Patients who are platinum ineligible may be enrolled if they have received and failed an approved treatment and lack a treatment option with curative potential.
For all arms except Arm L (pembrolizumab) and Arm M (nivolumab), patients must have failed prior standard curative chemotherapy for their disease; subjects must have failed, be intolerant to, or be ineligible for any potentially curative approved treatment, irrespective of line of therapy
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Waldenstroms macroglobulinemia must have failed courses of therapy
Has AML or ALL and failed any prior induction therapy regimen or have relapsed after prior therapy
Has failed standard treatment
Must have received and progressed on or failed one standard/approved treatment for cancer type, if available
Histologically documented, metastatic NSCLC that has failed at least one standard therapy
Subject must have metastatic or recurrent disease and have failed first-line systemic treatment, and if indicated, failed approved second-line therapy, and for whom no standard therapy options are anticipated to result in a durable remission