At least 1 but not more than 5 prior systemic therapies for advanced/recurrent or progressing disease.
Patients with recurrent disease or multiple primaries are ineligible
Patients with recurrent carcinoma of the vulva regardless of previous treatment
Patients must have radiologic evidence of recurrent, refractory or progressive malignant central nervous system (WHO grade III or IV) or solid tumor; for patients with radiologic features of DIPG histologic confirmation of diagnosis is not required though biopsy is suggested if clinically indicated
Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to enrollment
Patients with recurrent disease may have received multiple prior chemotherapies for treatment of their uterine cancer
Patients with esophageal cancer with unresected or recurrent primary tumors in the esophagus are only permitted after discussion of patient with study chair
Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment; eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin
Recurrent or refractory ALL limited to isolated testicular
Cohort B: Patients with recurrent endometrial cancer may have received up to 2 lines of cytotoxic chemotherapy (adjuvant and one line for recurrent disease, or 2 lines of chemotherapy for recurrent uterine cancer in patients who did not receive adjuvant chemotherapy); patients must have received and failed, or have been intolerant to platinum agents, taxanes, liposomal doxorubicin or other agents known to confer clinical benefit; patients are not required to fail all these agents if, in the investigator’s opinion, patients would benefit from treatment on current protocol
Recurrent or previously resected tumors
Any episode of recurrent disease following completion of aggressive multi-drug frontline therapy.
Recurrent disease that presents >100 days after, or minimal residual disease (MRD) that presents > 30 days after either:
recurrent/refractory disease after they received at least one prior standard treatment regimen
Have minimally symptomatic metastatic castration recurrent prostate cancer with bone lesions; this patient population is defined as having failed hormone treatment and has insurance approval for PROVENGE therapy
PART II: Greater than or equal to 1 week since receipt of standard or investigational HER2-directed therapy for metastatic or recurrent disease
No previous surgery for melanoma (other than complete macroscopic resection as stated above)(i.e. Not recurrent disease)
Participants with recurrent, progressive, or refractory brain tumors
Naive or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
Radiology evidence of reMB or recurrent grade III and IV glioma; patients will be considered for a biopsy or resection of the recurrent/progressive tumor at the discretion of the treating neurosurgeon and neuro-oncologist
Patients who need definitive radiotherapy for treatment of recurrent MB or recurrent grade III or IV glioma
Patients must have resistant/refractory or recurrent neuroblastoma
Recurrent or persistent histologically proven locoregional OCSCC (recurrent T-stage 2-4) that was initially treated with surgery alone; to allow sufficient tumor tissue for the immunological analyses, patients with T-stage 1 OCSCC will be excluded
Patients must have advance, recurrent or metastatic endometrial cancer
Patients must have recurrent disease, histologically proven or imaging suggestive of recurrent disease as determined by principal investigator (PI); prior implantation of Gliadel wafers is acceptable, if tumor recurrence is confirmed by histologic examination of the recurrent tumor
Recurrent or refractory disease for which no further effective standard treatment is available
Patients who already received chemotherapy for recurrent metastatic IBC are not eligible
Recurrent or progressive malignancy requiring anticancer treatment
Patients must have a confirmed recurrent/progressive brain malignancy that have failed at least one prior treatment regimen
Patients with recurrent endometrial cancer.
Prior progression on or within 8 weeks of the last dose of a platinum agent (i.e. cisplatin or carboplatin) for recurrent or metastatic disease
Recurrent or refractory disease according to NCI criteria
Newly-diagnosed chemo-naive or recurrent after curative-intent surgery\r\n* >= 6 months after completion of adjuvant therapy (including chemotherapy and/or radiotherapy)\r\n* No prior treatment with any targeted agent\r\n* Patients who have started first line mFOLFOX6 therapy (+/-trastuzumab for HER2 amplified tumors) may be considered for trial participation if they have received no more than 4 doses of therapy at the time of consent and screening\r\n** These patients will be required to meet ‘next cycle’ parameters for eligibility before commencing treatment on trial rather than being required to meet parameters as indicated below which is for previously untreated metastatic/recurrent patients
First episode of recurrent disease following completion of aggressive multi-drug frontline therapy.
Patients with macroscopic recurrent disease are allowed; macroscopic disease is defined as clinically detectable or evident on radiographic imaging
Persistent or recurrent elevations in levels of EBVDNA exceeding 500 copies/ml in patients previously treated for EBV lymphoproliferative disease (EBVLPD) with chemotherapy and/or Rituxan who do not yet have clinically or radiologically evaluable disease but are at high risk of disease recurrence
Patients must have progression of disease after radiotherapy (including patients that undergo surgery for recurrent disease and are rendered no evidence of disease [NED]); this includes recurrent glioblastoma multiforme (GBM) after receiving all standard first-line treatment, including surgery (if feasible due to neurosurgical and neuro-anatomical considerations) and adjuvant radiotherapy +/- chemotherapy
Subjects with recurrent disease
Subject has gastric outlet syndrome or persistent/recurrent vomiting.
Recurrent disease with an:
In Stage 1, recurrent or metastatic PR-expressing cancer that has the potential to benefit from an anti-progestin treatment including but not limited to endometrial cancer, ovarian, or breast cancer or uterine sarcoma. In Stage 2, recurrent or metastatic PR-expression uterine endometrioid adenocarcinoma that is determined to be APRpos.
Patients must have refractory, recurrent or metastatic disease, which is deemed to be inoperable
Histological diagnosis of recurrent or metastatic cervical, vaginal, or vulvar cancer
Primary or recurrent retroperitoneal or abdominal tumor
For expansion cohort: metastatic platinum-refractory cervical cancer, or metastatic/recurrent platinum-refractory HPV-positive head and neck cancer (as determined by polymerase chain reaction (PCR), in situ hybridization (ISH), or p16 immunohistochemistry (IHC); platinum refractory is defined as recurrent disease within 6 months after receiving cisplatin or carboplatin with radiation for their newly diagnosed disease, or after receiving cisplatin or carboplatin for their recurrent/metastatic disease
Progressive or recurrent breast cancer defined as disease progression or recurrence while on a combination of exemestane with everolimus
Recurrent or refractory ALL limited to isolated testicular disease
Patients who are to be given HDR brachytherapy for treatment of solid tumor of the following:\r\n* Gynecologic (primary cervix and recurrent cervix/uterine cancer)\r\n* Prostate (locally advanced/recurrent cancer)
Patients must have received at least one prior standard systemic therapy with documented recurrent or refractory disease
Patients may have received chemotherapy as a component of their primary tumor treatment but not for recurrent or metastatic disease
Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to enrollment
Patients with recurrent disease may not have received more than three prior chemotherapies for treatment of their uterine cancer
Patients must have clinically evident recurrent disease for the purpose of this study
Patients whom have already undergone secondary cytoreduction for recurrent disease are excluded
Widespread (metastatic) disease, or returned after previous treatment (recurrent)
Previous treatment for metastatic or recurrent disease
Subjects must have recurrent/metastatic disease and may have been previously treated in the recurrent/metastatic setting.
Patients with recurrent uterine LMS
Confirmed recurrent or metastatic disease
Previous chemotherapy for recurrent or metastatic disease.
Patients with recurrent WHO grade III gliomas should have received one prior treatment for recurrent high grade disease
Has received reradiation to recurrent disease (other than standard frontline adjuvant radiation therapy)
Patients must have confirmed Cushing's disease that is persistent or recurrent.
SCCHN that has progressed during or following at least 1 and up to 5 prior systemic treatments for metastatic or recurrent disease deemed to be incurable. Patient who refuse radical resection for recurrent disease or are intolerant of or refused standard first line therapy are eligible to enroll
Patients must have advanced or recurrent disease that is refractory to curative treatment based on imaging or clinical exam.
Patients must have had no more than two prior chemotherapeutic regimens for recurrent endometrial carcinoma. Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease.
Patients must have had one prior systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix (e.g.; paclitaxel/cisplatin, paclitaxel/cisplatin/bevacizumab), at least one which must have contained bevacizumab\r\n* NOTE: Patients are allowed to receive 1-2 prior regimens for management of recurrent, persistent or metastatic carcinoma of the cervix; patients who have received more than two prior systemic regimens for management of recurrent, persistent or metastatic carcinoma of the cervix are NOT eligible\r\n* NOTE: Prior adjuvant therapy is NOT counted as a systemic chemotherapeutic regimen for management of recurrent, persistent or metastatic carcinoma of the cervix; adjuvant therapy includes cisplatin given concurrent with primary radiation therapy (CCRT) and adjuvant chemotherapy given following the completion of concurrent chemotherapy and radiation therapy (e.g., paclitaxel and carboplatin for up to 4 cycles)
Patient must have recurrent epithelial ovarian cancer and may have received unlimited prior chemotherapeutic regimens for management of recurrent cancer
Metastatic or recurrent CRC
Histologically confirmed recurrent or metastatic SCCHN; tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent; Patients who have only received chemo-radiation with curative intent for treatment of their locally advanced disease or recurrent disease are not eligible. Patients who received concurrent chemo-radiation as part of treatment of their recurrent disease are also not eligible.
Received more than 1 regimen for recurrent or metastatic disease
The trial is open only to women with recurrent, progressive clear cell carcinoma of the ovary
Previously treated with 3 or more systemic regimens given for recurrent and/or metastatic disease
Presence of metastatic or recurrent disease
Tumor progression or recurrence during or after treatment with only 1 systemic palliative regimen for recurrent or metastatic disease that must have contained a platinum agent.
Received more than 1 systematic palliative regimen for recurrent or metastatic disease
Recurrent or persistent (after the failure of chemotherapy) disease that cannot be treated with surgery or radiotherapy;
Locoregionally recurrent or metastatic disease that has not previously been treated with systemic therapy of recurrent or metastatic disease
Patients must have had no more than two prior chemotherapeutic regimens for recurrent management of endometrial carcinoma; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is not counted as a prior treatment for recurrent or advanced disease
Diagnosis of recurrent or progressive HGG or DIPG
Patients must have recurrent or metastatic tumor located within a previously irradiated field
Interval of at least 12 weeks from prior radiotherapy unless there is either: a) histopathologic confirmation of recurrent tumor, or b) new enhancement on MRI outside of the radiation treatment (RT) field
Receiving any treatment for persistent, progressive or recurrent malignancy.
Progressive or recurrent malignancy defined other than by quantitative molecular assays.
Patients with recurrent or refractory ESFT. Patients with de novo poor prognosis/high risk ESFT: (Eligible for vaccine manufacturing at diagnosis but ONLY ELIGIBLE FOR IMMUNOTHERAPY IF DEMONSTRATES PERSISTENT/RECURRENT/ REFRACTORY DISEASE)
Patients who have undergone recent resection of recurrent or progressive tumor will be eligible as long as they have recovered from the effects of surgery. Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual measurable disease post-operatively, a MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively.
Patients must have received at least one platinum-based chemotherapy for recurrent/advanced disease; recurrent disease is defined as having recurred after definitive therapy and advanced disease is defined as T4 and/or N2 and/or M1; in addition, for completion of Cohort #2, patients must also have received a tubulin inhibitor as part of their therapy for urothelial cancer; for purposes of this evaluation, treatment with chemotherapy regimens where carboplatin or similar is substituted for cisplatin or where a taxane is added or removed will be considered the same regimen; tubulin inhibitors in common use include paclitaxel, docetaxel, and vinblastine; the exception to this requirement applies to women
Histologically documented cutaneous or mucosal malignant melanoma, which is recurrent or metastatic and is not curable by surgical or other means.
History of histological confirmation for recurrent disease, or if recurrent disease is not readily accessible to biopsy, must have two consecutive carcinoembryonic antigen (CEA) or cancer antigen (CA) 19-9 increases, or positron emission tomography (PET) avidity
Recurrent disease with an:
interval of at least 3 weeks between end of surgery for recurrent disease and start of protocol therapy for patients who have undergone surgery for recurrent disease
Any co-morbid condition that poses a greater threat to the patient’s life expectancy than the recurrent myeloma
Recurrent disease or second primary lung cancer (only de novo IIIA disease allowed)
Subjects with recurrent disease
Persistent and/or recurrent cervical cancer o No CNS/spinal metastases
For patients who have undergone resection of recurrent or progressive tumor prior to study enrollment, the following conditions must apply:
Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, an MRI should be performed:
At least 12 weeks from prior radiotherapy to the start of SL-701 unless there is new enhancement outside of the radiation field or unequivocal histopathologic evidence of recurrent tumor.
Any therapeutic regimen for treatment of recurrent tumor after first line treatment with surgery, radiation and temozolomide.
Any number of prior chemotherapy regimens for recurrent disease (Phase I); =< 1 chemotherapy or other non-antiangiogenic regimen for recurrent disease (Phase II)
For recurrent/progressive or refractory disease, a biopsy is not required regardless of number of MIBG avid lesions
Recurrent or refractory BRAFV600 mutant LGG or LCH tumors
Recurrent disease, refractory disease, or progressive disease after having received at least one standard therapy for their disease. Note: Subjects with metastatic (and surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma subjects with CNS involvement may be enrolled.
Patients must have recurrent and/or metastatic disease that is progressive and not amenable to surgery or curative radiotherapy occurring within 6 months of study entry, as evidenced by: at least a 20% increase in radiographically or clinically measurable disease, appearance of any new lesions, or deterioration in clinical status
History of NSCLC treated with surgery and/or radiotherapy previously and disease has been cured or clinically no disease progression for more than 6 months, now isolated recurrent disease in lung parenchyma and without involvement of main bronchus, chest wall, hilar/mediastinal lymph nodes and critical mediastinal structures; biopsy of recurrent disease is recommended
Prior treatment with an EGFR inhibitor as part of a regimen for recurrent or metastatic SCCHN
Subjects who have received more than one course of chemotherapy for recurrent disease
Patients with recurrent T1 disease who do not wish to have cystectomy.
Patient had histological confirmed diagnosis of osteosarcoma of the recurrent sample.
Diagnosis: \r\n* Part A: Recurrent or refractory neuroblastoma or melanoma\r\n* Part B: Recurrent or refractory neuroblastoma or melanoma\r\n* Part C: Recurrent or refractory osteosarcoma and Ewing sarcoma
DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment
Women with of primary or recurrent diagnosis of ovarian, uterine, peritoneal, cervical or vulvar cancer with any of the following:\r\n* < 30 % projected 5 year survival based on histopathological stage\r\n* Non-pelvic recurrent malignancy\r\n* Persistent or progressive disease despite primary treatment with surgery, chemotherapy or\r\n* Palliative performance scale < 60
Recurrent or persistent progressive disease which is refractory to curative therapy or established treatments and cannot be treated with surgery or radiotherapy;
Recurrent cancer following prior resection
First or recurrent presentations
Recurrent or progressive malignancy requiring anti-cancer therapy
Patient has recurrent hyperparathyroidism
Recurrent or progressive malignancy requiring anticancer treatment
History of recurrent or second primary H&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study
Recurrent cancer
Recurrent disease
Recurrent cancer
Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)
Patients with evidence of recurrent malignancy
Subjects must have experienced recurrent/progressive disease following treatment with a non-steroidal aromatase inhibitor (letrozole or anastrozole) in an adjuvant or metastatic setting
Synovial sarcoma that has been treated with standard chemotherapy containing ifosfamide and/or doxorubicin and remains: unresectable or metastatic or progressive/persistent or recurrent disease
A radiological diagnosis of recurrent/relapsed or progressive disease according to RANO criteria.
Recurrent tumors: patients with recurrent grade IV gliomas who have failed cranial radiation therapy
Patients with recurrent disease or a new primary will be allowed
Expected to undergo tumor tissue biopsy for known or suspected prostate cancer (in the primary, recurrent or metastatic disease setting)
Recurrent infratentorial tumor
Suspicion of recurrent prostate carcinoma after previous presumed definitive therapy for organ confined disease defined as :
Patients must have recurrent disease for which there is a clinical indication for resection
Any patient with recurrent or progressive cancer
Phase 3: Previous treatment with 3 or more systemic regimens given for recurrent and/or metastatic disease
ELIGIBILITY FOR STRATUM S PATIENTS TO START MAINTENANCE CHEMOTHERAPY
Participants must be Stratum S (SHH)
ELIGIBILITY FOR STRATUM S PATIENTS TO START MAINTENANCE CHEMOTHERAPY:
INCLUSION CRITERIA - STRATUM A:
INCLUSION CRITERIA - STRATUM B
Patient must have unresectable primary tumor or metastases (including tumors with an intralesional resection)\r\n* For Stratum 1, patients must have a confirmed histologic diagnosis of osteosarcoma\r\n* For Stratum 2, any histologically confirmed solid tumor diagnosis is eligible
PHASE II: Tumor tissue for correlative studies is required for all patients except those with NF1 and LGG (stratum 2) unless surgery was performed prior to enrollment or any patient with optic pathway glioma (stratum 2 or 3), for whom tumor tissue is optional
PHASE II: Patients for whom tumor biopsy and/or resection is clinically indicated and who are eligible for and enrolled on the phase II component (any stratum) will also be eligible for the optional target validation stratum
Stratum D: Patients must have a histologically confirmed diagnosis of ependymoma that is recurrent, progressive or refractory following therapy which included radiotherapy
Stratum E: Patients must have a histologically confirmed diagnosis of medulloblastoma that is recurrent, progressive or refractory following therapy which included radiotherapy
INCLUSION CRITERIA FOR STRATUM C: Patient must have completed immunotherapy (e.g. tumor vaccines, oncolytic viruses, etc.) at least 42 days prior to enrollment
INCLUSION CRITERIA FOR STRATUM C: Patients must be fully recovered from all acute effects of prior surgical intervention
INCLUSION CRITERIA FOR STRATUM C: Albumin >= 2 g/dl
INCLUSION CRITERIA FOR STRATUM C: Patients must be off all colony-forming growth factor(s) for at least 1 week prior to registration (i.e. filgrastim; sargramostim; erythropoietin); 2 weeks must have elapsed for long-acting formulations
INCLUSION CRITERIA FOR STRATUM C: Patients must be willing to use brief courses (at least 72 hours) of steroids as directed for potential inflammatory side effects of the therapy if recommended by their treating physician
EXCLUSION CRITERIA FOR STRATUM C: Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible
Stratum I
Stratum II
Patients of Stratum I who have:
Active disease at the end of Stratum I treatment
Disease reactivation in non-risk organs at any time after completion of Stratum I treatment
Stratum III
Patients from Stratum I who fulfill the following criteria:
Stratum IV
Patients from Stratum I or Stratum III who fulfill the following criteria:
Stratum V
Stratum VII -- All patients registered in LCH IV (regardless of treatment) as long as consent for longterm follow-up has not been withheld.
Stratum I
Stratum II
Stratum III
Stratum IV
Stratum VI
Patients with SS-LCH who have an isolated tumorous CNS lesion (they are eligible for Stratum V),
Patients with isolated \CNS-risk\ or multifocal bone lesions (they are eligible for Stratum I, Group 2)
STRATUM A: Participants with subependymoma or myxopapillary ependymoma
STRATUM A: Female participants who are breastfeeding a child
STRATUM B: Female participants who are breastfeeding a child
STRATUM C: Female participants who are breastfeeding a child
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 V600E mutation must have failed treatment with a BRAF inhibitor or are not considered to be eligible for such treatment
PHASE II: Patients with recurrent or progressive disease, as defined in the following three strata below, will be eligible; for eligibility determination, tumor imaging from at least two time-points must be available to document radiographic progression or recurrence; patients with non-progressive refractory tumors will not be eligible \r\n* Stratum 1: patients with LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging\r\n* Stratum 2: patients with NF1 and LGG that is measurable in at least two dimensions on imaging\r\n* Stratum 3: pediatric patients with a recurrent or progressive tumor thought to involve the Ras/Raf/ERK pathway but not included in strata 1 or 2 that is measurable in at least two dimensions on imaging; this includes any LGG not included in strata 1 or 2 (i.e., any LGG without a BRAF truncated fusion in a patient without NF1), any tumor other than LGG in a patient with NF1, and any other tumor with a documented activating BRAF, NRAS, or KRAS mutation\r\n* Stratum 4 (surgical arm, target validation): patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated
PHASE II: Tumor tissue for correlative studies is required for all patients except those with NF1 and LGG (stratum 2) or any patient with optic pathway glioma (stratum 2 or 3), for whom tumor tissue is optional
Patients with clinical contraindication against lumbar puncture or Ommaya placement are NOT eligible for either Stratum
At least 28 days must have elapsed (at time of starting protocol therapy) since completion of focal radiation therapy for current recurrence for Stratum 2; patients who have already undergone radiation therapy for current recurrence are NOT eligible for Stratum 1
Patients receiving systemic corticosteroids are NOT eligible for either Stratum
INCLUSION CRITERIA FOR PATIENTS ON ALL STRATA EXCEPT STRATUM P
EXCLUSION CRITERIA FOR ALL STRATA EXCEPT STRATUM P
INCLUSION CRITERIA FOR PATIENTS TO BE TREATED ON STRATUM A
Patients with progressive synchronous/metachronous AT/RT and MRT will be eligible for stratum A3
INCLUSION CRITERIA FOR PATIENTS ON STRATUM D
INCLUSION CRITERIA FOR PATIENTS ON STRATUM P
Biological parent of patient enrolling on SJATRT will be assigned to Stratum P
Patients with other malignancies will not be eligible for stratum I or II; patients with disseminated disease including to the spine will not be eligible for stratum 1 but will be eligible for stratum II
Patients with newly diagnosed DIPG who have received vorinostat previously will not be eligible for stratum I; patients with progressive DIPG will be eligible if they have received either one of the two drugs vorinostat or temsirolimus but will not be eligible for stratum II if have received both the drugs before
Patients with previous history of irradiation at any dose to thoracic-spine, ribs or >= 20% of bone marrow cannot undergo TMI and will be eligible for bortezomib, fludarabine, and melphalan regimen (Stratum II); patients can be enrolled on Stratum II at their physician's discretion or if patients decline radiation therapy
Patients in Stratum F must have received craniospinal radiation
Presence of metastatic disease for patients in Stratum A, B, D and E; patients with metastatic high grade gliomas diagnosed at < 1 year of age are eligible for Stratum D at the time of recurrence; patients with low grade gliomas (Stratum C) may have tumor spread within the CNS; patients in Stratum F must have tumor spread within the CNS
STRATUM II:\r\n* MDD >= 1% and MRD negative (< 0.01%) on day 8 in T-lymphoblastic lymphoma \r\n* Bone marrow involvement microscopically present at diagnosis in B-lymphoblastic lymphoma \r\n* Any CNS involvement: CNS-3 status (i.e., >= 5 WBC/uL of CSF with blasts or cranial nerve palsy), CNS-2 status (< 5 WBC/uL of CSF with blasts) or traumatic LP (> 10 RBC/uL of CSF with blasts) but does not fulfill the criteria of stratum 3 \r\n* Overt testicular involvement (evidenced by ultrasonogram) but does not fulfill the criteria of stratum 3
Patient must have a histologically verified diagnosis of craniopharyngioma\r\n* Stratum 1: patients with progressive unresectable or recurrent craniopharyngiomas treated with surgery alone, who have not received radiation therapy; patients with unresectable craniopharyngiomas, (i.e. residual measurable disease following surgical resection) will be enrolled at the time of progression\r\n* Stratum 2: patients with progressive or recurrent craniopharyngiomas following radiation therapy; the patient must be at least 6 months post irradiation to be eligible
Stratum 1: patients must not have received radiation therapy
Stratum 1 patients: must not have had > 3 surgical debulking procedures/resections
STRATUM A INCLUSION CRITERIA:
STRATUM B INCLUSION CRITERIA:
Metastatic disease for stratum B only
Specific eligibility criteria stratum 1:\r\n* Disease status: \r\n** Radiographic disease progression as defined for stratum 3 (below) is not required for trial entry\r\n** Patient does not have clinical symptoms from the plexiform neurofibroma
Specific eligibility criteria stratum 2:\r\n* Disease status: \r\n** Radiographic disease progression as defined for stratum 3 (below) is not required for trial entry\r\n** Patient has clinical symptoms from the plexiform neurofibroma
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Absolute neutrophil count >= 1,000/mm^3
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Albumin >= 3 g/dl
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who have had > 60 Gy total radiation to the pons (e.g. patients who have received re-irradiation)
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had prior histone deacetylase (HDAC), deacetylase (DAC), heat shock protein 90 (HSP90) inhibitors for the treatment of their DIPG
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have had prior bone marrow transplant
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have any other significant concurrent illness
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have a history of any other malignancy
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who are receiving any other anticancer or investigational drug therapy
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients who are required to receive any medication which can prolong the QTc interval
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Female patient is breastfeeding
NON-PROGRESSED DIPG (STRATUM 2): Patients with DIPG who have not yet progressed by clinical or radiographic criteria\r\n* Please note: patients with a radiographically typical DIPG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons, are eligible without histologic confirmation\r\n* Patients with pontine lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of malignant glioma World Health Organization (WHO) II-IV
NON-PROGRESSED DIPG (STRATUM 2): Absolute neutrophil count >= 1,000/mm^3
NON-PROGRESSED DIPG (STRATUM 2): ALT(SGPT) =< 3 x institutional upper limit of normal
NON-PROGRESSED DIPG (STRATUM 2): Albumin >= 3 g/dl
NON-PROGRESSED DIPG (STRATUM 2): Potassium >= LLN
NON-PROGRESSED DIPG (STRATUM 2): Patient has no ventricular arrhythmias except for benign premature ventricular contractions
NON-PROGRESSED DIPG (STRATUM 2): Patient has a QTc interval < 450 ms
NON-PROGRESSED DIPG (STRATUM 2): Patients must be off all colony-forming growth factor(s) for at least 7 days prior to enrollment (i.e. filgrastim, sargramostim or erythropoietin); 14 days must have elapsed if patients received PEG formulations
NON-PROGRESSED DIPG (STRATUM 2): Patients who have had > 60 Gy total radiation to the pons (e.g. patients who have received re-irradiation
NON-PROGRESSED DIPG (STRATUM 2): Patients have significant acute deterioration in neurologic status in 72 hours prior to enrollment, in the opinion of the treating physician
NON-PROGRESSED DIPG (STRATUM 2): Patients have diarrhea > CTCAE grade 2
NON-PROGRESSED DIPG (STRATUM 2): Patients have a history of any other malignancy
NON-PROGRESSED DIPG (STRATUM 2): Patients who are receiving any other anticancer or investigational drug therapy
NON-PROGRESSED DIPG (STRATUM 2): Patients who are required to receive any medication which can prolong the QTc interval
NON-PROGRESSED DIPG (STRATUM 2): Female patient is breastfeeding
Skin lesions on the breast that disrupt the stratum corneum (e.g. eczema, ulceration)
Specific Criteria by Stratum: Stratum 1: All patients must have completed standard upfront therapy that replicates treatment which patients who were enrolled on ANBL0032 received, including: intensive induction chemotherapy and (if feasible) resection of primary tumor, followed by: consolidation with high-dose chemotherapy with stem cell transplant and radiotherapy, followed by: immunotherapy with Ch14.18/IL-2/GM-CSF (dinutuximab) and retinoic acid;. All subjects on Stratum 1 must have also met the following criteria: • A pre-transplant disease status evaluation that met International Neuroblastoma Response Criteria (INRC) for CR (complete response), VGPR (very good partial response), or PR (partial response) for primary site, soft tissue metastases and bone metastases. Patients who meet those criteria must also meet the protocol-specified criteria for bone marrow response prior to transplant as outlined below: No more than 10% tumor involvement (based on total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy. Stratum 2: Neuroblastoma that is in first complete remission following standard upfront therapy different from that described for Stratum 1. Stratum 3: Neuroblastoma that failed to have a response of at least PR following induction chemotherapy and surgical resection of the primary tumor, but that has achieved CR following additional therapy. Stratum 4: Patients who have achieved a second or subsequent CR following relapse(s).
Skin lesions on the breast that disrupt the stratum corneum (e.g., eczema, ulceration)
Skin lesions that disrupt the stratum corneum (eg., eczema, ulceration) or any breakdown of the skin
Prior therapy\r\n* Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound; this initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment\r\n* Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens (a total of 3 cytotoxic regimens) for management of recurrent or persistent disease according to the following definition:\r\n** Patients who have received only one prior cytotoxic regimen (platinum-based regimen for management of primary disease), must have a platinum-free interval of less than 12 months, or have progressed during platinum-based therapy, or have persistent disease after a platinum-based therapy\r\n** Patients must NOT have received any non-cytotoxic therapy for management of recurrent or persistent disease other than bevacizumab containing regimens; patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy as part of their primary treatment regimen
Patients are allowed to receive, but are not required to receive, up to 5 additional prior chemotherapy treatment regimens (including platinum-based chemotherapy); prior hormonal therapy is allowed, does not count towards this prior regimen requirement, and must be discontinued at least one week prior to T cell infusion; continuation of hormone replacement therapy is permitted
Patients are allowed to receive, but are not required to receive, biologic/targeted therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, up to 5 biologic/targeted therapies as part of their treatment regimen for recurrent disease (either alone or in combination with chemotherapy)
Participants are allowed to receive, but are not required to receive, biologic/targeted (noncytotoxic) therapy as part of their primary treatment regimen
Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease; patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease
Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease
Patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted agents, such as bevacizumab) therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); PARP inhibitors will NOT count as a prior regimen when given alone
Patients are allowed to receive, but are not required to receive, up to two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 prior non-platinum cytotoxic chemotherapeutic regimen\r\n* Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their prior treatment; for the purposes of this study, poly (ADP-ribose) polymerase (PARP) inhibitors will be considered “cytotoxic\; patients are allowed to receive, but are not required to receive, PARP inhibitors for management of primary or recurrent/persistent disease (either alone or in combination with cytotoxic chemotherapy); single agent hormonal therapies will not be counted as a line of treatment
Patients are allowed to receive, but are not required to receive, two additional cytotoxic regimens for management of recurrent or persistent disease, with no more than 1 non-platinum regimen; treatment with weekly paclitaxel for recurrent or persistent disease is NOT allowed
Patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic (biologic/targeted) therapy as part of their treatment for recurrent or persistent disease and/or as treatment for recurrent or persistent disease; if non-cytotoxic (biologic/targeted) therapy is given alone (i.e., not in combination with cytotoxic chemotherapy) it will NOT count as a prior regimen
one additional cytotoxic regimen and/or PARP inhibitor for management of recurrent or persistent disease.
biologic therapy (e.g., bevacizumab) as part of their primary treatment regimen or part of their treatment for management of recurrent or persistent disease.
Patients are allowed to receive, but are not required to receive, one additional cytotoxic regimen for management of recurrent or persistent disease
Patients are allowed to receive, but are not required to receive, one additional prior treatment regimen (including a single chemotherapeutic, a combination of chemotherapeutics, or biologic drugs such as bevacizumab) for management of their recurrent or persistent disease
Patients are allowed to receive, but are not required to receive, biologic/targeted (non-cytotoxic) therapy as part of their primary therapy and/or as part of their therapy for advanced, metastatic, or recurrent disease (e.g., bevacizumab)
Patients are allowed to receive, but are not required to receive, three additional cytotoxic regimen for management of recurrent or persistent disease; hormonal therapies will not count toward the prior regimen limit
Patients are allowed to receive, but not required to receive biologic (noncytotoxic) therapy as part of their treatment regimen, e.g. bevacizumab
Patients must not have received any non-cytotoxic therapy for management of recurrent or persistent disease, except hormonal based therapy is allowed; patients are allowed to have previously received, but are not required to have received non-cytotoxic therapy as part of their primary treatment regimen
Patients are allowed to receive, but are not required to receive, non-cytotoxic therapy (such as bevacizumab) as part of their primary treatment regimen; patients are allowed to receive, but are not required to receive, non-cytotoxic therapy for management of recurrent or persistent disease
No more than 3 prior systemic treatment regimens for advanced PNET
Has received at least 2 prior regimens of standard treatment
Received ? 2 prior chemotherapy regimens and have relapsed or progressive disease as confirmed by radiologic assessment
UCC and SCCHN and salivary gland cancer - No more than three different prior treatment regimens in the advanced/metastatic setting with a maximum of two chemotherapy-containing regimens
Patients may have had up to 3 prior regimens for metastatic disease
Evidence of progressive disease during or following no more than 2 prior chemotherapy regimens
Received 1 or 2 prior standard of care regimens for advanced or metastatic disease
Progressed on or intolerant of at least 2 prior cancer therapy regimens administered for metastatic disease.
Any number of prior treatment regimens
Progressive disease after >= 1 prior chemotherapy regimens
Status post 1 or more unmatched systemic therapy regimens for enrollment to group 3
Progressive disease after 1-3 prior chemotherapy regimens (perioperative chemotherapy within 12 months will be considered one regimen)
There is no limit to the number of prior chemotherapy regimens received; patients must have received at least one line of prior systemic chemotherapy for advanced unresectable and/or metastatic disease
Any number of prior chemotherapy regimens are allowed
Triple negative (ER-/PR-/HER2-) (Note: This group of patients must have received at least 1 and up to 3 prior chemotherapy regimens in the advanced setting.)
Patients must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic or unresectable disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
Patients who received imatinib and 1 or 2 other TKIs as prior treatment regimens. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment onto BLU-285-1303 study.
Patients who have received more than 3 different prior TKI treatment regimens.
Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin; there is no limit to the number of prior chemotherapy regimens received
Part A patients who have received more than 3 prior cytoreductive chemotherapy regimens.
Patients must have had at least two prior chemotherapeutic or biologic (e.g. rituximab alone) regimens and not currently eligible for standard curative options; steroids alone and local radiation do not count as regimens
Patients previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Patients must have received at least one prior chemotherapy regimen and up to any number of prior systemic regimens including chemotherapy and molecular targeted therapy other than PD1/ PDL1/ PDL2 inhibitors
Up to 3 prior chemotherapy regimens or metastatic disease
Received at least 3 prior chemotherapy-containing regimens.
Received fewer than 3 prior chemotherapy-containing regimens.
Subjects have received at least two standard chemotherapy regimens for which they would be considered eligible (at least one containing a 5-fluoropyrimidine), or systemic chemotherapy is not indicated in the setting of low volume metastatic disease
PRE-SCREENING: Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant chemotherapy would not be counted as a line of therapy)
Patients must have had at least one prior chemotherapy regimen that includes pemetrexed and cisplatin or carboplatin; there is no limit to the number of prior chemotherapy regimens received
Have had disease progression, be refractory or intolerant to no more than 2 prior systemic regimens.
Received 3 or more prior myelotoxic treatment regimens
Patients must have previously received systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
There is no limit on the number of prior treatment regimens
Patients receiving any other investigational agents and or more that two different chemotherapy regimens for treatment of metastatic disease
Patients with any prior chemotherapy regimens are eligible
There is no limit to the number of prior treatment regimens provided that performance status and life expectancy meet the criteria above
There is no limit to the number of prior systemic treatment regimens
Phase I: patients are eligible with any number of prior regimens regardless of what those regimens contained (i.e. prior bortezomib or combination gemcitabine and adriamycin is acceptable)
There is no limit on number of prior regimens
Patients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Patients may be enrolled in the study regardless of prior chemotherapy regimens
Patients must have previously received prior first line standard therapy (or effective salvage chemotherapy regimens) for their disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Patients must have previously received first line standard therapy (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Received 3 or more prior myelotoxic treatment regimens
Chemotherapy refractory large cell and high grade NHL (i.e. progressive disease after > 2 salvage regimens)
Chemotherapy refractory large cell and high grade NHL (i.e., progressive disease after > 2 salvage regimens)
Has received 2-6 prior chemotherapy regimens including taxanes in advanced setting Additional Inclusion Criteria for Dose Expansion Part Only:
Must have received at least 2 prior regimens of standard chemotherapy for mCRC and must have been refractory to or failed (includes intolerance to) those regimens. Prior standard chemotherapy may not have included TAS-102 or regorafenib, but must have included agents as specified in the protocol.
Part 1 patients may have an unlimited number of prior therapy regimens
Patients are allowed (but not required) to have up to two lines of prior chemotherapy regimens for metastatic disease
Systemic chemotherapy washout period >= 7 days; for investigational dugs and monoclonal antibodies washout period >= 5 x drug half-life; there are no limitations on number of prior treatment regimens
Prior chemotherapy with 0-2 regimens is allowed
Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol
Participants who have received oxaliplatin during prior systemic chemotherapy regimens are eligible for enrollment in this protocol
Must have failed at least 1 regimen for metastatic disease, and have been treated with up to 2 prior chemotherapy regimens\r\n* There is no limit on the number of total prior regimens
Patients must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
Is ineligible or inappropriate for other treatment regimens known to have effective potential
Disease progression after 1 prior ALK inhibitor therapy other than crizotinib. Patients may have had any number of prior chemotherapy regimens in any disease setting.
Disease progression after 2 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting.
Disease progression after 3 prior ALK inhibitor therapies. Patients may have had any number of prior chemotherapy regimens in any disease setting. ROS1-positive NSCLC patients may be:
Patients Must have completed 3 or 4 previous chemotherapy regimens.
Has previously received at least 2 prior regimens for advanced disease and were refractory to or unable to tolerate their last prior therapy.
Patients are allowed to receive any number of prior chemotherapy regimens for recurrent disease
At least one, but no more than three, prior chemotherapy regimens for MBC.
Received and experienced disease progression on, or following one or two prior chemotherapy regimens for advanced disease.
Group B any number of prior regimens.
Received 3 or more prior myelotoxic treatment regimens
Documentation of recurrent or progressive GBM following at least one (1) prior therapeutic regimen including upfront radiation and chemotherapy with temozolomide; up to three additional therapeutic regimens for disease progression prior to enrollment to the study is permitted
Patients will be ineligible if they have advanced myeloma refractory to salvage chemotherapy regimens
Patients must have received less than 3 prior chemotherapy regimens for progressive meningioma
No more than 4 prior chemotherapeutic regimens for metastatic disease
No more than three prior systemic chemotherapy regimens
Patients who have relapsed or are refractory to at least one prior chemotherapy regimen, and for whom no standard therapy exists; there is no limit to the number of prior chemotherapy regimens received
Any number of prior treatment regimens is allowed
> 2 prior chemotherapy regimens
Subject may have received ?2 prior regimens for the treatment of their metastatic disease.
Patients with breast cancer may have received neoadjuvant or adjuvant chemotherapy and up to two prior chemotherapy regimens for metastatic or locally recurrent disease; subjects with ovarian cancer may have had two regimens for advanced or persistent disease
Other chemotherapy regimens may have been administered between the time of progression on prior trastuzumab containing regimen and protocol therapy; no restriction on prior chemotherapy regimens for advanced stage disease
COHORT I: Patients must have received at least one and no more than two prior systemic therapy regimens; at least one of the regimens must have included pemetrexed and a platinum
Any number of prior chemotherapy regimens is allowed
Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
More than two prior regimens for therapy of MM
There is no limit on the number of prior chemotherapy regimens allowed; any prior treatment (with the exception of lanreotide or octreotide) must be completed at least 4 weeks prior to initiation of treatment
More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1 prior regimen; switching front-line therapy regimens (for example, from intraperitoneal to intravenous therapy) for reasons other than progression will count as 1 prior therapy; bevacizumab and other ‘targeted’ agents will count in the total number of prior regimens; vaccine therapies will not count in the total of prior therapies
Must have had at least 1 but no greater than 3 prior anti-myeloma regimens.
Any number of prior regimens is allowed; prior investigational therapy is allowed
Relapsed after ? 2 prior chemotherapy- or immunotherapy-based regimens for indolent NHL, or refractory to 2 prior chemotherapy and/ or immunotherapy-based regimens.
Patients with transformed indolent lymphoma must have received at least 2 prior chemotherapy- and/or immunotherapy-based regimens
Patients that have been treated with > 3 prior chemotherapy regimens
Patients with up to 2 prior chemotherapy regimens are eligible
Receipt of no more than three prior chemotherapy regimens; monoclonal antibody therapy alone and involved field radiotherapy are not included in this number; prior use of ofatumumab is allowed if there has been no disease progression following that therapy (i.e. ofatumumab-based salvage regimens are allowed)
Have received at least three prior chemotherapy regimens and have relapsed disease confirmed by radiologic assessment
Any number of prior chemotherapy regimens is permitted
There is no limit on the number of prior treatment regimens
Patients with recurrent or progressive disease after one or more regimens of pre-radiation chemotherapy
Patients must have had at least one prior therapy to be eligible for either the first or second stage a) Patients are eligible with any number of prior regimens regardless of what those regimens contained (i.e. prior Bortezomib or combination gemcitabine and adriamycin is acceptable).
Women with TNBC who have received at least one but no more than two prior chemotherapy regimens for TNBC
Patients who have had more than 4 prior chemotherapy regimens
Prior chemotherapy regimens =< 1
Chemotherapy: no limit to prior therapies; however, patients with multiple chemotherapy regimens will be screened for lymphocyte proliferation at investigator’s discretion
No more than 2 prior chemotherapy regimens.
Patients may not have received more than 4 prior regimens of therapy
Must have received the following treatment for glioblastoma: •Prior treatment with radiotherapy and temozolomide; Note: A maximum of two prior chemotherapy/antibody regimens (including bevacizumab or other direct VEFG/VEGFR inhibitors) for recurrent disease are permitted.
PANCREATIC CANCER COHORT (COHORT 4 ONLY): Patients must have had at least one prior chemotherapy for advanced disease; there is no limit to the number of prior chemotherapy regimens received
Patients must have previously received at least one systemic standard care (or effective salvage chemotherapy regimens) for metastatic disease, if known to be effective for that disease, and have been either non-responders (progressive disease) or have recurred
Prior treatment with ? 2 prior chemotherapy-based or immunotherapy-based regimens for iNHL
Radiographic progression during treatment with erlotinib; prior chemotherapy regimens are permitted
Patients should have received a minimum of one, and up to five prior chemotherapy regimens
Any number of prior systemic therapeutic regimens including chemotherapy, pathway inhibitors, biochemotherapy, investigational agents, and immunotherapies other than ipilimumab or bavituximab
Patients who have failed at least 1 systemic chemotherapy regimen for metastatic disease, but not more than 2 regimens
Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
No more than 2 prior regimens are allowed
Patients must have progressed on or been intolerant to a fluoropyrimidine-based chemotherapy regimen; there is no limit on the number of prior treatment regimens permitted
Any number of prior treatment regimens are allowed
Subject previously treated with chemotherapy must have no more than two prior chemotherapy regimens for the treatment of metastatic prostate cancer
Patients may have an unlimited number of prior therapy regimens
Patient received at least 2 prior regimens for MM.
More than one prior chemotherapy regimens
No more than two prior chemotherapy regimens for metastatic disease
Have received more than 3 prior CTX regimens
No more than 3 prior chemotherapy regimens
=< 2 prior chemotherapeutic regimens
Those receiving alternate regimens and those with other disease types
Have received prior chemotherapy regimens within 4 weeks of Day 1;
Patients must also receive a full myeloablative preparative regimen (patients treated with either total body irradiation (TBI)-based or high-dose chemotherapy only regimens are eligible other than high-dose busulfan containing regimens or regimens that include anti-thymocyte globulin or other T cell depleting antibodies)
Patients that are receiving or have received chemotherapy regimens are allowed
Intolerance to at least 2 prior standard therapy regimens
Two or more prior chemotherapy regimens for advanced disease
Zero or one prior chemotherapy regimens for metastatic disease
At least 1, but no more than 5, prior treatment regimens for MCL
Patients must have received less than three prior chemotherapy regimens for progressive meningioma
At least ? 2 prior treatment regimens for the underlying malignancy