Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung confirmed by tumor biopsy and/or fine-needle aspiration; disease must be stage IV SCCA, or recurrent; the primary diagnosis of SCCA should be established using the current World Health Organization (WHO)/International Association for the Study of Lung Cancer (IASLC)-classification of Thoracic Malignancies; the diagnosis is based on hematoxylin and eosin (H&E) stained slides with or without specific defined immunohistochemistry (IHC) characteristic (p40/p63 positive, transcription termination factor [TTF1] negative) if required for diagnosis; mixed histologies are not allowed
Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients are not eligible
For the diagnosis of pure germinoma, HCGbeta (serum and CSF) must be =< 100 mIU/ml, serum AFP must be =< 10 IU/l (ng/ml) and =< institutional norm and initial CSF AFP =< 2 IU/l (ng/ml) and =< institutional norm with histologically proven diagnosis of germinoma at diagnosis or subsequent relapse
Subjects must be =< 90 days from diagnosis of PCNSL in the brain or spine; time from pathologic diagnosis to initiation of treatment should be specified; subjects with history of only ocular lymphoma are eligible if < 90 days since documented brain parenchymal disease (by imaging or by biopsy)
SURGICAL STUDY (STRATUM 2): Patients must have recurrent or refractory disease with a histological diagnosis at either the time of diagnosis or at the time of recurrence of one of the following: \r\n* HGG\r\n* Medulloblastoma, \r\n* CNS embryonal tumor (NOS), \r\n* Ependymoma, or \r\n* ATRT
Must have a confirmed diagnosis of active MM
Participants who have a diagnosis of an immunodeficiency
Has diagnosis of immunodeficiency
Subject must have documented diagnosis of either:
Has a diagnosis of immunodeficiency
Prior diagnosis of inherited or acquired immunodeficiency
Has a diagnosis of immunodeficiency
Diagnosis of any of the following:
Diagnosis:
Has a diagnosis of immunodeficiency
Confirmed diagnosis of SAA, either from initial diagnosis or follow-up assessments, defined as:
Histopathologically confirmed diagnosis of one of the following:
Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis
Confirmed diagnosis of CMML
Clinical diagnosis of one of the following:
Histologic diagnosis of B-Cell NHL. Histology based upon bone marrow biopsies and/or fine needle aspirates as the sole means of diagnosis are not acceptable. All patients must have measurable disease. Any tumor mass of at least 1.5 cm is acceptable.
If tissue diagnosis is not feasible for any reason, such as undue risk to the patient to acquire tissue diagnosis, the following will be accepted as confirmed AR-PCNSL diagnosis:\r\n* Positive brain fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) and\r\n* EBV detected in the cerebrospinal fluid (CSF) using polymerase chain reaction (PCR)
Patients with newly diagnosed DIPG by magnetic resonance imaging (MRI); defined as patients with a pontine location and diffuse involvement of at least 2/3 of the pons are eligible without histologic diagnosis. For lesions with typical imaging features, biopsy is neither encouraged nor required for eligibility. Tumors that are biopsied will be eligible if proven to be supportive of the diagnosis of a DIPG. Consensus of diagnosis by the study team must be met.
Diagnosis and Prior Treatment:
DIAGNOSIS:
Any diagnosis of autoimmune disease (confirmed by medical records or appropriate laboratory testing)
Diagnosis of cutaneous, paranasal sinus, salivary, or nasopharynx SCC, or diagnosis of neck nodes with unknown primary
Has a diagnosis of immunodeficiency
Has a diagnosis of congenital immunodeficiency
Histologic diagnosis of Richter’s syndrome (RS)
Patients with newly diagnosed DIPG by magnetic resonance imaging (MRI); defined as patients with a pontine location and diffuse involvement of at least 2/3 of the pons are eligible without histologic diagnosis; for lesions with typical imaging features, biopsy is neither encouraged nor required for eligibility; tumors that are biopsied will be eligible if proven to be supportive for the diagnosis of a DIPG; consensus of diagnosis by the study team must be met
Has an active diagnosis of interstitial cystitis.
Histologic diagnosis of GIST
Has a diagnosis of immunodeficiency
Histologic/molecular diagnosis of malignancy at diagnosis or the time of relapse
Diagnosis must be made by surgical excision
Has a diagnosis of immunodeficiency
Prior diagnosis of thrombosis or known hypercoagulable state
Diagnosis of immunodeficiency
Patients must be entered within 12 weeks of diagnosis
Pathologic confirmation of the diagnosis either at original diagnosis or recurrence
Diagnosis of unresectable metastatic colorectal adenocarcinoma with liver-dominant bilobar disease; diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria as is standard of care at University of California, San Francisco (UCSF)
Confirmed diagnosis of invasive BCC
Must have a confirmed diagnosis of active MM
Diagnosis must be made by biopsy or excision
Diagnosis of Gilbert’s disease
For subjects without underlying cirrhosis at the time of diagnosis, diagnosis of HCC documented by cytology and/or histology.
For subjects with underlying cirrhosis at the time of diagnosis, diagnosis of HCC established according to the American Association for the Study of Liver Diseases Practice Guideline algorithm (Appendix E).
All patients must have a procedure for determining diagnosis of high-risk uterine cancer (HRUC); minimum surgical intervention required is tissue biopsy (may be from endometrium), if significant clinical evidence exists to support a stage 3 or 4 diagnosis; as per the discretion of the surgeon, complete surgical staging should include: total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node samplings; this is typically the standard unless the disease is bulky or the clinician feels the patient would be best served by chemotherapy and radiation therapy after histologic diagnosis is confirmed
Patients must have evidence of disease progression as demonstrated by an increase of > 50% in lymphocytosis since diagnosis and/or lymphadenopathy and a lymphocyte doubling time of more than 6 months; patients must have had at least 3 months of observation since diagnosis
Known diagnosis of deficiency of the interleukin-1 receptor antagonist (DIRA)
Patient must not have a diagnosis of Gilbert’s disease
Patient must not have a diagnosis of sclerosing cholangitis
Confirmed diagnosis of select advanced malignancy
Pathologic diagnosis to be confirmed at Massachusetts General Hospital (MGH) or other Dana-Farber/Harvard Cancer Center (DF/HCC) institution; in cases of progressive or recurrent disease, pathologic diagnosis may be from time of original biopsy and/or surgery
For the diagnosis of pure germinoma, HCGB (serum and CSF) must be =< 100 mIU/ml, serum AFP must be =< 10 IU/l (ng/ml) and =< institutional norm and CSF AFP =< 2 IU/l (ng/ml) and =< institutional norm with histologically proven diagnosis of germinoma at diagnosis or relapse
Diagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a treatment plan that will include high dose therapy and stem cell transplantation
Age at diagnosis < 6 months (i.e., < 183 days)
Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor
Confirmed beta-thalassemia diagnosis by molecular genetic testing
Existing diagnosis of any type of dementia
Pathological diagnosis of pancreatic adenocarcinoma before first treatment but may be enrolled with presumed diagnosis based on clinical and radiologic evaluation with confirmation made by biopsy at time of EUS prior to AdV-tk injection
Mammogram within 6 weeks of diagnosis
Diagnosis of intrahepatic cholangiocarcinoma.
Pregnant at time of or within prior year of diagnosis
Pathologically confirmed diagnosis of liposarcoma; all subtypes are eligible
Diagnosis of active dermatomyositis
Patients must have histologic diagnosis of osteosarcoma at original diagnosis
Diagnosis of immunodeficiency
Diagnosis of immunodeficiency
Has a diagnosis of immunodeficiency
Diagnosis of NF2
Diagnosis of PMBCL.
Documented diagnosis of any of the following:
Subjects must have a pathologically confirmed diagnosis of PMF as per the WHO diagnostic criteria or post ET/PV MF;
Have confirmed diagnosis of MPM with the following characteristics:
The diagnosis of mCRC will be based on histologic or cytologic confirmation
Confirmed diagnosis of PMF or post-PV/ET MF
Clinical and definitive histologic diagnosis of WM
Has a diagnosis of immunodeficiency
Prior progesterone treatment for either diagnosis is ALLOWED
History or recent diagnosis of demyelinating disease
Diagnosis of fibromyalgia
Prior surgical treatment for this diagnosis
Life expectancy of at least 10 years from the time of diagnosis, not considering the melanoma in question, as determined by the PI.
Diagnosis of immunodeficiency
Has a diagnosis of immunodeficiency
A confirmed diagnosis of WM, which requires treatment.
Centrally confirmed clinicopathological diagnosis of WM
Molecular diagnosis of CP CML of ? 6 months (from initial diagnosis).
Confirmed diagnosis of PMF in accordance, or Post-PV/ET MF
Diagnosis of:
Has a diagnosis of:
Diagnosis of sclerosing cholangitis
Patients with a diagnosis of chronic hepatitis B are ineligible due to the possibility of immunosuppression on study treatment
Diagnosis of symptomatic MM
Diagnosis other than osteosarcoma.
Patients with an immunodeficiency that existed prior to diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and children on current systemic immunosuppressive agents are not eligible
Diagnosis must be made by surgical biopsy or excision
Diagnosis of one of the following:
Patients with a diagnosis of intrahepatic cholangiocarcinoma
Genetically confirmed diagnosis of VHL or measurable disease consistent with the clinical diagnosis of VHL
Patients who have a diagnosis of Gilbert’s disease
Subjects that relapse within one year of diagnosis
Histologic diagnosis has been verified by institutional pathologist and classified according to the WHO (2007) system
Age < 3 years at time of diagnosis for all histological diagnosis
Less than 12 months since diagnosis
Diagnosis of AA
AbGn-168H (neihulizumab) therapy can begin not more than 14 days after diagnosis of aGvHD
Primary diagnosis of uveal melanoma at least 12 mm in largest basal diameter as clinically determined by the treating investigator; cytologic determination of diagnosis is not required; size is based on clinical assessment (e.g. by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy
Must have a confirmed diagnosis of WM as defined by the Second International Workshop, with a clinical indication for treatment.
Histopathological documentation of MCC concurrent with the diagnosis of metastatic disease
Previous diagnosis of another malignancy with any evidence of residual disease
Diagnosis of PMF or Post PV/ET-MF
Confirmed diagnosis of advanced malignancy:
Confirmed diagnosis of refractory celiac disease Type 2 (RCD-II)
The diagnosis of metastatic disease will be fulfilled by one of two criteria: previous pathological diagnosis of cancer with suspicion of metastatic disease on imaging, and clinical diagnosis of metastatic disease; if there is not pathological diagnosis, a specimen will be sent to pathology at the time of the surgery to confirm malignancy
Have a diagnosis of FAP
Diagnosis of sclerosing cholangitis
> 18 months (mos.) and =< 35 years at the time of initial diagnosis
Patients must have been =< 35 years at the time of initial diagnosis
A known diagnosis of Wilson’s disease
Eligible patients will have either confirmed or suspected new diagnosis of lung cancer and have sought a surgical consult relating to this diagnosis
Patient has a doctor diagnosis of COPD
Patients with a pathologic diagnosis of malignancy
Enroll =< 3 months post-diagnosis (as soon as possible after diagnosis is desirable)
History or diagnosis of a disease affecting hemostasis
Known diagnosis of hypocortisolism
Known diagnosis of pituitary hormone deficiency
Have a diagnosis of incurable cancer of any type; at any time in the diagnosis as long as they have at least a 4 month life expectancy based on the opinion of the attending physician
Will allow participation of patients at any time since diagnosis
Patients without a diagnosis of a gynecologic malignancy
Diagnosis of a hormone responsive malignancy
Have a diagnosis of untreated hypo- or hyper- thyroidism
Greater than 6-months post diagnosis
Diagnosis of mental retardation.
Known major psychiatric or neurological diagnosis
Diagnosis of meningitis or encephalitis
There will be no restrictions on time since diagnosis for participants
Diagnosis of malignancy treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)\r\n* New diagnosis of malignancy within 1-10 weeks of enrollment\r\n* New diagnosis of recurrent disease (after initial remission) or refractory disease at any time during therapy
Diagnosis of fibromyalgia
Open pancreatoduodenectomy for any diagnosis
Lack of documentation for a diagnosis of NF1
Diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer
Have sleep problems that began before diagnosis and have not changed since diagnosis
Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
Diagnosis of osteoporosis
Active diagnosis of alcoholism
Diagnosis of familial adenomatous polyposis (FAP) or attenuated familial adenomatous polyposis (AFAP), defined as at least one of the following:\r\n* Genetic diagnosis with confirmed APC mutation (Clinical Laboratory Improvement Act [CLIA] certified lab or research testing)\r\n* Obligate carrier\r\n* Clinical diagnosis of classic FAP with >= 100 colorectal adenomas status post colectomy and a family history of FAP\r\n* Clinical diagnosis of FAP, based on personal and family history; Note: This criterion requires documented review and agreement from either the study chair or the Cancer Prevention Network (CPN) lead investigator
New diagnosis of carcinoma
Subjects must have at least two atypical nevi of >= 4 mm diameter and prior diagnosis of melanoma
History or diagnosis of Paget’s disease
Diagnosis of immunodeficiency or active autoimmune condition.
Suspected but pathologically unconfirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder on the basis of clinical diagnosis, radiologic features, or findings from prior biopsies OR
Diagnosis of NF1
Subjects must have:\r\n* Diagnosis of NF1 with a lesion concerning for MPNST\r\n** Criteria include pain, growth of a known plexiform neurofibroma, abnormality on functional imaging study (FDG-PET) or change in clinical exam OR\r\n* Diagnosis of NF1 with a histologically confirmed MPNST
Patients with a diagnosis of intra-axial brain tumor at initial diagnosis or patients with known treated brain tumors on follow-up with concern for imaging progression
Major psychiatric diagnosis prior to neuro-oncological diagnosis
Participants with a clinical diagnosis of neurofibromatosis type 2 (NF2) (either by National Institutes of Health [NIH] or Manchester criteria) or with a molecular diagnosis of NF2
Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or metastatic) by standard clinical diagnosis such as pathology or imaging
Less than ten biopsies obtained at time of diagnosis
Prior diagnosis of fibromyalgia
Diagnosis of a core binding factor leukemia (t(8;21), t(16;16) or inv(16)).
Diagnosis of dementia
Have a diagnosis of any type of NHL and =< 5 years from the last treatment
Patients with a diagnosis that qualifies them for UCBT
Diagnosis of 1 of the following diseases:
Patients with recurrent or refractory solid tumors, including CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or in patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Diagnosis: \r\n* Part A: Patients with recurrent or refractory solid tumors, including lymphoma and CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\r\n* Part B: Patients with recurrent or refractory high grade glioma (World Health Organization [WHO] grade III/IV) including disseminated tumors (excluding diffuse intrinsic pontine glioma [DIPG]), not requiring surgical resection; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Part C: Patients with recurrent or refractory high grade glioma (WHO grade III/IV) and requiring surgical resection (excluding DIPG and disseminated tumors), who in the opinion of treating physicians, are medically stable to receive 3-4 doses of selinexor (8-10 days of treatment) before undergoing surgery without compromising the success of the procedure; note that if, in the opinion of treating physicians, current symptoms necessitate surgery before 3-4 doses will be able to be received, surgery should not be delayed to administer selinexor, and the patient would be ineligible for protocol therapy
Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Patients with recurrent or refractory solid tumors, including CNS tumors and lymphoma, for which no standard therapy is available are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
PHASE I (STRATUM 1): Patients with a histologically confirmed diagnosis of a primary CNS tumor that is recurrent, progressive, or refractory; all tumors must have histologic verification of HGG, medulloblastoma, CNS embryonal tumor (NOS), ependymoma, or ATRT; patients with low-grade gliomas are excluded
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
Subjects must have had histologic verification of malignancy at original diagnosis or relapse, except in subjects with optic pathway gliomas, or subjects with pineal tumors and elevations of serum or cerebrospinal fluid (CSF) alpha-fetoprotein (AFP) or beta-human chorionic gonadotropin (HCG)
Ependymoma (World Health Organization [WHO] grade II) or anaplastic ependymoma (WHO grade III) that has relapsed or become refractory to standard therapy; patients must have had histologic verification of their malignancy at original diagnosis or time of recurrence
Part A: Patients with recurrent or refractory solid tumors are eligible, excluding central nervous system (CNS) tumors; patients must have had histologic verification of malignancy at original diagnosis or relapse
Part B: Patients with recurrent or refractory osteosarcoma are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse
Part A: Patients with recurrent or refractory non-CNS solid tumors are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except patients with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG); patients in part A cannot have CNS metastases
Part B: Patients with recurrent or refractory CNS tumors will be eligible and must have a histological verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with CNS-germ cell tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-HCG
Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma.
Patients must have had histologic or flow cytometric verification of the malignancy at relapse
Patients with recurrent or refractory solid tumors, including central nervous system (CNS) tumors or lymphoma, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Subject has histological verification of tumor either at the time of diagnosis or recurrence. Subjects with DIPG are exempt from histologic verification if they have typical Magnetic resonance imaging (MRI) findings of DIPG
The target tumor is limited to neuroblastoma; patients must have had histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines at the time of initial diagnosis
Subjects must have had histologic verification of neuroblastoma at original diagnosis or relapse
Patients with refractory or recurrent solid tumors for which there is no standard therapy are eligible; patients must have had histologic verification of malignancy at original diagnosis or at the time of relapse
Subjects must have had histologic verification of malignancy at original diagnosis or relapse; all subjects with relapsed or refractory solid tumors are eligible including primary or metastatic CNS tumors; in the case of diffuse intrinsic pontine glioma (DIPG), or optic pathway glioma, imaging findings consistent with these tumors will suffice without the need for biopsy for histologic verification
Patients must have had a previous histological verification of a solid tumor at the original diagnosis and/or recurrence including brain tumors; for patients with brain stem gliomas and optic pathway tumors, the requirement for histological evaluation may be waived; the patient’s disease must be considered refractory to conventional/standard therapy, or a disease for which no conventional therapy exists and is progressive
Patients must have a diagnosis of neuroblastoma verified at diagnosis, or at the time of relapse by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites; patients with non-neuroblastic MIBG avid tumors are also eligible including but not limited to paraganglioma and pheochromocytoma
Patients with relapsed or refractory solid tumors (excluding primary central nervous system tumors) are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse.
Patient must have a documentation of prior diagnosis of NB or ganglioneuroblastoma either by histologic verification and/or demonstration of tumor cells in the bone marrow with increased catecholamine levels
Diagnosis: patients with recurrent/refractory medulloblastoma (MB), atypical teratoid (AT)/rhabdoid tumors (RT) or ependymoma involving the brain and/or spine at original diagnosis or relapse; they must have histological verification at diagnosis and/or relapse; patient must have presented with these tumors in the posterior fossa (PF) or relapsed in the PF
Diagnosed with neuroblastoma either by histological verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma.
Relapsed/refractory neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical neuroblastoma cells in the bone marrow
Phase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ? 1 prior line of therapy.
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
Subjects must have had histologic verification of a malignancy at original diagnosis or relapse; all subjects with relapsed or refractory solid tumors are eligible, excluding CNS tumors
PRE-REGISTRATION: At least one documented histological verification of solid tumor diagnosis. Can be from original diagnosis or more recent.
Stratum 1: Recurrent or refractory primary malignant central nervous system (CNS) tumor patients \r\n* Patients with a histologically confirmed diagnosis of a primary malignant non-brainstem CNS tumor (excluding DIPG patients) that is recurrent, progressive, or refractory; all tumors must have histologic verification at either the time of diagnosis or recurrence except patients with marker (+) CNS germ cell tumors
Patients must have had histologic verification of AML at original diagnosis
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines
Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse \r\n* Primary strata\r\n** Wilms tumor\r\n** Rhabdomyosarcoma\r\n** Neuroblastoma\r\n* Secondary strata: miscellaneous CD56-expressing tumors:\r\n** Pleuropulmonary blastoma\r\n** Malignant peripheral nerve sheath tumor (MPNST)\r\n** Synovial sarcoma
Patients must have had verification of the malignancy at relapse, including immunophenotyping to confirm diagnosis
Diagnosis: \r\n* Phase 1 (Part A)\r\n** Solid tumors (Part A1): patients with relapsed or refractory solid tumors including central nervous system (CNS) tumors without bone marrow involvement are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\r\n** Ewing sarcoma or peripheral primitive neuroectodermal tumor (PNET) (Part A2): patients with relapsed or refractory Ewing sarcoma or peripheral PNET without bone marrow involvement will be eligible for Part A2 if there are no available slots on Part A1; these patients will be enrolled at one dose level below the dose level at which patients on Part A1 are actively enrolling, or at the starting dose level (dose level 1) if dose escalation has not yet occurred; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Phase 2 (Part B)\r\n** Ewing sarcoma or peripheral PNET: patients with relapsed or refractory Ewing sarcoma or peripheral PNET are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* Phase 2 (Part C)\r\n** Acute lymphoblastic leukemias (ALL): patients must have 2nd or greater relapse of pre-B ALL or T-cell ALL; patients may not have refractory disease\r\n** Patients with ALL must have had histologic verification of the malignancy at the most recent relapse, including immunophenotyping to confirm diagnosis
Patients must have had histologic verification of malignancy at original diagnosis or relapse; all patients with relapsed or refractory solid tumors or anaplastic large cell lymphoma (ALCL) are eligible except for patients with primary or metastatic central nervous system (CNS) tumors or patients with primary cutaneous ALCL
Patients must have had histologic verification of the malignancy at original diagnosis or at the time of recurrence
Patients must have had histologic verification of malignancy at original diagnosis or relapse
Patients must have had histologic verification of neuroblastoma or ganglioneuroblastoma or demonstration of neuroblastoma cells in the bone marrow with elevated urinary catecholamines (i.e., > 2 x upper limit of normal [ULN]), at the time of initial diagnosis
Patients must have relapsed or become refractory to conventional therapy, with a regimen including some combination of high dose methotrexate, doxorubicin, cisplatin, ifosfamide and etoposide; and have had histologic verification of osteosarcoma at original diagnosis or at the time of recurrence
Patients must have had histologic verification of the malignancy at original diagnosis; patients must have histologic verification of recurrent Hodgkin disease at the time of relapse; no additional biopsy is required for patients with primary refractory disease (i.e. no prior CR)
Patients must have histologic verification of malignancy; histologic confirmation for patients with optic pathway gliomas will not be required
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse
Patients must have had histologic verification of solid tumor, including lymphomas, at original diagnosis or relapse except in patients with intrinsic brain stem tumors, patients with optic pathway gliomas, and patients with pineal tumors and elevations of serum or cerebrospinal fluid (CSF) alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Patients must have had histologic verification of osteosarcoma at original diagnosis
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines.
Solid tumor, including central nervous tumors, that is recurrent or refractory to standard therapy or for which standard therapy is not available; all research participants must have a pathologic diagnosis either from their initial presentation, or at the time of recurrence or progression; the requirement for histologic verification may be waived for patients with brainstem glioma and optic pathway glioma
ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors (including non-Hodgkin lymphomas, histiocytoses [e.g. Langerhans cell histiocytosis (LCH), juvenile xanthogranuloma (JXG), histiocytic sarcoma], and central nervous system [CNS] tumors) are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-HCG
Diagnosis: histologic verification at either the time of original diagnosis or a previous relapse of high risk neuroblastoma.
Diagnosis: histologic verification at either the time of original diagnosis or a previous relapse of high risk neuroblastoma.
Diagnosis: Histologic verification at either the time of original diagnosis or relapse of neuroblastoma or medulloblastoma.
Patients must have a diagnosis of neuroblastoma either by histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamine metabolites
Patients must have histologic verification of osteosarcoma at initial diagnosis or relapse
Diagnosis: patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound
Part 1: Patient with any advanced or metastatic solid tumor
Part 2A: Patient with any advanced or metastatic solid tumor
Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
Histopathologically confirmed melanoma, Merkel cell carcinoma or other solid tumor malignancy
Group A: Subjects with any solid tumor (including lymphomas).
Histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable), with measurable disease per RECIST v1.1
Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease and have at least 1 lesion accessible for biopsy
histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor.
Diagnosis of advanced solid tumor cancer, lymphoma, or myeloma (no time restrictions or limitations) -OR- diagnosis of early stage solid tumor cancer, lymphoma, or myeloma <= 12 months prior to study enrollment
Patient with advanced or metastatic solid tumor and has disease progression or treatment intolerance after treatment with available therapies
Advanced melanoma or PD-L1-positive advanced, relapsed, or refractory solid tumor or lymphoma
Has a diagnosis of locally advanced or metastatic solid tumor
Solid tumor located in central lung
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
If the study Sponsor decides to evaluate additional solid tumors, subjects must satisfy following criteria to be included in the study: Has a pathologically documented advanced solid tumor.
Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
Radiographically confirmed solid tumor brain metastases
Advanced solid tumor malignancy without curative options
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Histologic proof or unequivocal cytologic proof of solid tumor malignancy; this may be obtained from either the primary or any metastatic site
Pathologically-proven diagnosis of a solid tumor malignancy
Advanced, solid tumor malignancy that is amenable to biopsy; patient must consent to 4 mandatory biopsies during study
Pathological diagnosis of any solid tumor histology (from any site in the body)
Pathologic confirmation of solid tumor, including central nervous system tumor or lymphoma, or leukemia
Histologic, cytologic, or radiologically evidence of locally advanced, residual, or recurrent solid malignancy of the abdomen or pelvis requiring surgical resection
Histologic or cytologic confirmation of advanced solid tumor.
Pathologically confirmed advanced solid tumor cancers
Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit but based on evidence gathered in this study or from external sources, the Sponsor in consultation with the Investigators, may decide to limit to specific tumor types.
Patients with a hematologic malignancy or solid tumor
Patients with more than one malignancy (hematologic or solid tumor) are eligible
Histologically documented diagnosis of solid tumor
Diagnosis of advanced solid tumor or hematologic malignancy (limited to lymphoma) that has failed or become intolerant to standard therapy
Malignancy (solid tumor or lymphoma) that is currently not amenable to surgical intervention due to either medical contraindications or nonresectability of the tumor.
advanced or metastatic solid tumor (Part A)
Subject must have an advanced solid tumor
cMET dysregulated advanced solid tumor
Any advanced unresectable/stage IV solid tumor with exception of primary central nervous system (CNS) malignancy is permitted.
PRE-REGISTRATION: Patients older than 21 years must have a solid tumor considered by study doctor to be of the childhood cancer type.
Diagnosis during dose escalation (Part 1) - Pathologically documented, definitively diagnosed non-resectable advanced solid tumor.
Group 4 - patients must have a pathologically documented, definitively diagnosed advanced solid tumor with a RET alteration, other than NSCLC and MTC.
Patients must have pathologically confirmed diagnosis of a solid tumor cancer for which there is no known standard therapy capable of extending life expectancy
Pathologic proven diagnosis of solid tumor malignancy
Subjects with a histologic diagnosis of solid tumor cancers of epithelial origin.
Histologic or cytologic confirmation of a solid malignancy with established intolerance or refractoriness to standard therapies
Pathologic proven diagnosis of solid tumor malignancy
Part 3: advanced solid tumor or hematologic malignancy
Part 4: select advanced solid tumor or hematologic malignancy
Histologic confirmation of advanced solid tumors
Subjects with any previously treated advanced (metastatic or refractory) solid tumor
Subjects must have a previously treated advanced solid tumor to be eligible
Solid tumor contact with SMA > 180°
Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
History of hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years
Have biomarker-positive solid tumor
Advanced solid tumor for which no other higher priority therapies are available
Patient with solid tumor malignancy with leptomeningeal metastases established radiographically and/or through CSF cytology.
Patients must have radiographically-confirmed recurrent brain metastases from a solid tumor after WBRT
A solid tumor diagnosis in the setting of:
Pathologic diagnosis of solid tumor malignancy that is locally advanced or metastatic at time of Screening with documented HER2 expression.
Pathologically documented diagnosis of advanced solid tumor malignancy that progressed after appropriate prior therapy or has no potential for cure with currently available treatments.
Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor
Subject must have a pathologically documented, definitively diagnosed, advanced solid tumor
Diagnosis of an advanced solid tumor malignancy.
Have histologic or cytologic documentation of solid tumor including EGFR mutated (EGFRm) NSCLC
Part A: Any type of solid tumor (\all comer\)
Relapsed or progressive advanced solid tumor malignancies
Advanced solid tumors with histologic diagnosis confirming cancer
Part 1 (enrollment closed): an advanced, incurable solid tumor
Part 2 (enrollment closed): an advanced, incurable solid tumor for whom a taxane would be considered a reasonable chemotherapy option
Advanced solid tumor malignancy
Patient has a confirmed diagnosis of a select solid tumor (except ALK+ NSCLC) or hematological malignancy and is in need of treatment because of radiologic progression or relapse.
Solid tumor cohort (B1) specific criteria
Patients with solid tumor other than CRC.
Pathologic proven diagnosis of solid tumor malignancy
Subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor
Phase I: Diagnosis of recurrent, metastatic or primary unresectable solid tumor that does not have curative standard treatment
Histologic or cytologic confirmation of a solid malignancy
Has histological diagnosis of a primary solid tumor malignancy that meets study criteria
Diagnosis of a solid tumor malignancy (any stage)
Adults with a primary diagnosis of any advanced solid tumor cancer within the last 3 years
Solid tumor survivors with no evidence of disease
Solid tumor cancer diagnosis
Pathologically-confirmed solid tumor or hematologic malignancy with symptomatic bone metastases
=< 30 days post diagnosis of a solid tumor or lymphoma
Histologic diagnosis of malignancy of a solid organ or lymphoma
Incurable solid tumor malignancy
Subjects with histological diagnosis of incurable cancer (solid tumor)
Diagnosis of a metastatic or incurable solid tumor
Participants with advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options.
Diagnosis of a proven solid tumors or newly diagnosed mass strongly suspected to represent a solid tumor
Patients with histopathologic diagnosis of a solid tumor. All solid tumors will be considered, but patients with breast, pancreas, and colorectal masses will be prioritized.
Patients with an extracoelomic solid tumor requiring SLN biopsy
Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
Patients with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist.
Have a confirmed diagnosis of advanced, refractory solid tumors and tumor progression or treatment intolerance to at least 1 prior therapy.
Confirmed advanced solid tumor or hematologic malignancy