Patients must be at least weeks and within weeks from documented progressive disease (PD) on Step of current study; all sites of disease must be evaluated within weeks prior to registration
Patient should be randomized in the trial ideally within a maximum of weeks of completion of their last treatment (surgery, chemotherapy or radiotherapy), but in no case longer than weeks
Group B and C patients who do not enroll on ANBL within weeks of definitive diagnostic procedure
Infants must be > weeks gestational age at the time of enrollment
Patient has received any of the following treatments within the specified timeframes: a. Surgery, radiotherapy, chemotherapy (including molecular-targeted drugs): weeks ( days), b. Immunosuppressants or cytokine formulations (excluding G-CSF): weeks ( days), c. Endocrine therapy or immunotherapy (including biological response modifier therapy): weeks ( days)
- Treatment with an immunomodulatory agent within weeks prior to first administration of BI .
Radio- or toxin-immunoconjugates within weeks
Prior therapy with intravesical Bacillus Calmette-Guerin (BCG) within weeks of treatment.
RBC transfusion of either - pRBC units over the weeks prior to randomization or pRBC in two consecutive periods of weeks within the weeks prior to randomization
ESA use of less than days and no ESA within the weeks prior to randomization
Carmustine (BCNU): days/ weeks
Any of the following therapies prior to registration:\r\n* Chemotherapy =< weeks\r\n* Immunotherapy =< weeks\r\n* Biologic therapy =< weeks\r\n* Hormonal therapy =< weeks\r\n* Monoclonal antibodies =< weeks\r\n* Radiation therapy =< weeks\r\n* CDK / inhibitors =< weeks\r\n* mTOR inhibitors =< weeks
Previous cytotoxic therapies, including cytotoxic investigational agents, for multiple myeloma within weeks ( weeks for nitrosoureas) prior to randomization. IMiDs, PIs and or corticosteroids within weeks prior to randomization. Other investigational therapies and monoclonal antibodies within weeks of randomization. Prednisone up to but no more than mg orally q.d. or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least days prior to randomization
Participants must meet the following windows from procedures (there is no window required for port placement since there is no anticipated impact on wound healing with bavituximab):\r\n* Major surgery (ex. craniotomy) within weeks of initiation of treatment\r\n* Brain biopsy within weeks
Patients must not have received systemic therapy within weeks of initiating palbociclib; NOTE: For the HER-positive cohort, patients on trastuzumab can remain on the drug; no break or washout period required; however, lapatinib, ado-trastuzumab-emtansine, and pertuzumab are prohibited and a minimum wash out period of weeks is required
Recent initiation of bone modifying therapy with a bisphosphonate or denosumab unless it has been started more than weeks prior to the first dose of the study regimen; patients who are already enrolled in this study can initiate bone modifying therapy after the first set of re-staging scans (>= weeks from cycle , day )
Have received radioimmunotherapy (eg, I-tositumomab, Y-ibritumomab tiuxetan) less than weeks before the first dose of AG-.
Major surgery within weeks of the first dose of BVD-; tumor embolization procedure or ablation procedure within weeks of first dose of BVD-
Interferon, everolimus (mTOR-inhibitors), sunitinib or other systemic therapies within weeks prior to enrollment; bevacizumab within weeks prior to enrollment
Time since the last prior therapy to treat underlying malignancy to start of drug:\r\n* Cytotoxic chemotherapy: greater than the duration of the most recent cycle of the previous regimen (with a minimum of two weeks for all)\r\n* Biologic therapy (e.g., antibodies): >= four weeks\r\n* >= x t/ of a small molecule therapeutic, not otherwise defined above, with a minimum of weeks (including aromatase inhibitors and tamoxifen)
Prior Therapies:\r\n* There is no maximum number of prior medical therapies\r\n* There must be no curative or life prolonging treatments available\r\n* Patients who have received other IGF-R antibodies or inhibitors are eligible, as long as an appropriate washout period has elapsed \r\n* Participants must have had their last fraction of external beam radiation therapy that is local and palliative at least weeks prior to enrollment, and had their last substantial bone marrow radiation at least weeks prior to enrollment\r\n* Participants must have had their last dose of temozolomide at least weeks prior to enrollment; their last dose of other cytotoxic chemotherapy at least weeks prior to enrollment; their last dose of biological therapy, such as biological response modifiers (e.g., cytokines), immunomodulatory agents, vaccines, differentiating agents, used to treat their cancer at least days prior to enrollment, their last dose of a monoclonal antibody at least half-lives prior to enrollment, and their last dose of any investigational agent at least weeks prior to enrollment\r\n* Participants must have recovered from the acute toxic effects of prior therapy to a grade (Common Terminology Criteria for Adverse Events [CTCAE] version [v.].) level prior to enrollment (does not apply to alopecia)
Alemtuzumab or ATG within weeks of enrollment.
Patients with HGG: Have received anticancer therapies including: radiation therapy to current site of disease within weeks of dose assignment, targeted agent therapy within weeks of dose assignment, nitrosoureas within weeks of dose assignment, procarbazine within weeks of dose assignment, or other cytotoxic agents within weeks of dose assignment
Completion of any prior treatment with radiation, chemotherapy, biologics, and/or other investigational agents at least weeks prior to the first dose of ibrutinib; patients must have completed any prior immunotherapy (e.g., rituximab or PD- inhibition) or antibody drug conjugate therapy (e.g. brentuximab vedotin) at least weeks prior to the first dose of ibrutinib in the absence of clear disease progression
Cholangitis that required treatment or intervention within weeks of study enrollment
Small pox vaccination for weeks before study therapy and during study treatment
Intravesical chemo- or biologic therapy within weeks of first treatment
Biologic therapy (eg, antibodies), other than ADCs: ? weeks
A minimum of weeks from prior systemic anti-cancer therapies or weeks for radiation treatment prior to enrollment is required
Have taken any chemotherapeutic agent within weeks of treatment with the NanoKnife irreversible electroporation (IRE) system
Treatment indicated based on demonstration of at least one of the following no more than weeks from the time of enrollment, and no less than months after prior purine analog and no less than weeks after other prior treatment, if applicable
At the investigators discretion, receipt of a live vaccine within weeks prior to randomization; efficacy and/or safety of immunization during periods of B-cell depletion have not been adequately studied; it is recommended that a patients vaccination record and possible requirements be reviewed; per the investigators discretion, the patient may have any required vaccination/booster administered at least weeks prior to the initiation of study treatment; review of the patients immunization status for the following vaccinations is recommended: tetanus; diphtheria; influenza; pneumococcal polysaccharide; varicella; measles, mumps and rubella (MMR); and hepatitis B; patients who are considered to be at high risk for hepatitis B virus (HBV) infection and for whom the investigator has determined that immunization is indicated should complete the entire HBV vaccine series at least weeks prior to participation in the study
Patients who have received antiandrogens such as flutamide, bicalutamide, or nilutamide for > months immediately before enrollment on this study must be off treatment for weeks ( weeks for bicalutamide) and demonstrate a continued rise in PSA. Patients on antiandrogens for < months must be off medication for weeks.
Treatment with plasmapheresis within weeks before enrollment
Systemic chemotherapy ? weeks ( weeks for clofarabine or nitrosoureas) or radiation therapy ? weeks prior to apheresis; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea may be enrolled provided there has been no increase in dose for at least weeks prior to starting apheresis\r\n* Patients who are on standard ALL maintenance type chemotherapy (vincristine, -mercaptopurine, oral methotrexate or tyrosine kinase inhibitors in patients with Philadelphia [Ph]+ ALL) may be enrolled provided that chemotherapy is discontinued at least week prior to apheresis\r\n* Subjects receiving steroid therapy are allowed provided there has been no increase in dose for at least week prior to starting apheresis; patients on physiologic steroids will not be excluded\r\n* For radiation therapy: Radiation therapy must have been completed at least weeks prior to enrollment, with the exception that there is no time restriction if the volume of bone marrow treated is less than % and also the subject has measurable / evaluable disease outside the radiation port
For cohort , patients must be at least weeks from radiation therapy; additionally, patients must be at least weeks from nitrosoureas, weeks from temozolomide, weeks from procarbazine, weeks from vincristine and weeks from last bevacizumab administration; patients must be at least weeks from other cytotoxic therapies not listed above and weeks for non-cytotoxic agents (e.g., interferon) including investigative agents
Must have undergone a nephrectomy and/or metastasectomy ? days prior to signing informed consent and ? weeks prior to randomization.
Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), -alpha reductase inhibitors (finasteride, dutasteride), estrogens, chemotherapy, or biologic therapy within weeks of enrollment (day visit)
Completion of most recent salvage therapy within weeks of enrollment
Patients must be off cancer-directed therapy for at least weeks ( weeks for oral agents) prior to day of the study
At least weeks (or half-lives, whichever is longer) wash-out since the end of previously administered experimental therapy ( weeks if previous nitrosourea containing regimen) or weeks for standard-of-care regimens. Concurrent corticosteroids are allowed provided they are administered at an equivalent prednisone dose of ? mg/day, as prediction or blood products only;
Androgens such as testosterone, dehydroepiandrosterone (DHEA), etc. unless discontinued at least two weeks prior to randomization.
Any mAb or other protein therapeutic containing Fc-domains within weeks of enrollment
Previous cytotoxic therapies, including cytotoxic investigational agents, within weeks ( weeks nitrosoureas) prior to start of study treatment; previous corticosteroids used with intent to treat amyloidosis within three weeks; (prednisone up to but no more than mg orally once a day [q.d.] or its equivalent for symptom management of comorbid conditions is permitted but dose should be stable for at least days prior to study treatment)
Pegvisomant, within weeks
Dopamine agonists, within weeks
Pasireotide, within weeks
Patients must discontinue antiandrogen therapy (i.e. bicalutamide, flutamide, nilutamide) at least - weeks prior to registration with no evidence of PSA decline after washout\r\n* Bicalutamide: Washout period at least weeks\r\n* Flutamide and nilutamide: Washout period at least weeks
Patient has had a surgical procedure weeks prior to TURBT or will have other surgical procedures performed at the time of TURBT or within weeks after TURBT
Planning to relocate within the next - weeks
Elective surgery for treatment of the cutaneous metastases during the study and up to weeks after the treatment period. Cutaneous metastases are required to remain in-situ and measurable for up to weeks after last treatment to achieve study objectives;
Life expectance of >= weeks
I therapy not allowed within weeks before entry ( weeks if negative post-treatment scan)
I therapy within weeks before entry ( weeks if negative post-treatment scan)
History of use of another IP within the last weeks prior to enrollment.
Prohibited treatments and or therapies\r\n* Autologous stem cell transplant (ASCT) =< weeks prior to first dose of the study drug\r\n* Prior treatments (window prior to registration): \r\n** Chemotherapy =< weeks\r\n** Nitrosureas =< weeks\r\n** Therapeutic anticancer antibodies =< weeks\r\n** Radio- or toxin immunoconjugates =< weeks\r\n** Radiation therapy =< weeks\r\n** Or major surgery =< weeks\r\n* Prior treatment with an anti-PD-, anti-PD-L, anti-PD-L, anti-CTLA- antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways\r\n* Prior allogeneic stem cell transplant (SCT)\r\n* Chest radiation =< weeks prior to registration
FULL STUDY INCLUSION CRITERIA: Hemoglobin (Hb) >= g/dL, without blood transfusion or erythropoietin within weeks before the start of study treatment\r\n* Note: patients receiving chronic low-dose erythropoietin for chronic renal failure are allowed provided no dose adjustment is undertaken within weeks before signing consent for full study and until safety follow-up visit and provided that they fulfill conditions of eligibility criteria
For MM patients only:\r\n* Prior radiotherapy within weeks prior to the administration of study drug\r\n* Surgery within weeks\r\n* Chemotherapy (Chemo) within weeks ( weeks for melphalan, or monoclonal antibodies)
Patients must discontinue antiandrogen therapy (i.e., flutamide, bicalutamide, nilutamide) for at least weeks prior to registration with no evidence of a falling PSA after washout
LYMPHODEPLETION: Treatment with any investigational drug within days (ie, two weeks) prior to lymphodepletion or has received any tumor vaccines within the previous five weeks prior to lymphodepletion
Prior therapeutic intervention with any of the following:\r\n* Therapeutic anticancer antibodies within weeks (rituximab), except within months for obinutuzumab or a similar investigational type II monoclonal antibody;\r\n* Radio- or toxin-immunoconjugates within weeks;\r\n* Inhibitors of BTK (ibrutinib), PI-K (idelalisib), BH-mimetic venetoclax, lenalidomide and other targeted therapy (including but not limited to investigational BTK and PI-K inhibitors, etc.) within half-lives (i.e., hours for ibrutinib)\r\n* All other chemotherapy, radiation therapy within weeks prior to initiation of therapy\r\n* SYK inhibitors at any time
Within weeks since any plasmapheresis
Washout of weeks is required for aromatase inhibitors; washout of weeks is required for CDK / inhibitor, everolimus or other biological agent
Discontinuation of bicalutamide or nilutamide less than weeks, and other antiandrogens less than weeks, abiraterone less than weeks, prior to the start of study medication.
Administration of any of the following within the specified timeframe prior to the first dose of study drug:\r\n* weeks from TMZ\r\n* weeks from a nitrosoureas\r\n* weeks from a biologic or targeted agent (i.e. small molecule)\r\n* weeks for a VEGF inhibitor (i.e. bevacizumab)
Prior aromatase inhibitor therapy first initiated > weeks prior to study enrollment
Treatment with any of the following anti-cancer therapies prior to the first dose of BGJ within the stated timeframes\r\n* Cyclical chemotherapy (intravenous) within a period of weeks unless there are ongoing side effects > grade \r\n* Biological therapy (including small molecules, and/or) within a period of time that is =< weeks prior to starting study drug unless there are ongoing side effects > grade \r\n* Any other investigational agents within a period =< weeks prior to starting study drug unless there are ongoing side effects > grade \r\n* Wide field radiotherapy (including radioisotopes) =< weeks prior to starting study drug unless there are ongoing side effects > grade
Treatment with high dose immune inhibitors including lymphotoxic monoclonal antibodies such as campath, or rapamycin and its analogs or cytotoxic agents less than weeks prior to enrollment.
Patients must have the following minimum intervals from prior treatments:\r\n* Surgery weeks\r\n* Nitrosoureas weeks\r\n* Cytotoxic chemotherapy standard intervals depending on the most recent regimen. i.e., for temozolomide of , days after most recent temozolomide; for temozolomide of days, days after most recent dose; etoposide of days, days after last dose; for drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval\r\n* Investigational therapy or non cytotoxic therapy weeks
A minimum time period must elapse between the end of a previous treatment and start of study therapy:\r\n* week from the completion of radiation therapy for brain metastases\r\n* weeks from the completion of chemotherapy or any experimental therapy\r\n* weeks from prior major surgery (such as open biopsy or significant traumatic injury)
Treatment with plasmapheresis within weeks prior to event
More than weeks from completion of chemoradiation, unless RANO criteria for early progression within weeks of chemoradiation are met (See .)
Receipt of a prior investigational study agent within weeks prior to enrollment; *Note- patients who have received anti-CD CART cells (e.g. CART/cytotoxic T lymphocyte [CTL] ) on an investigational study where cell infusion occurred greater than weeks before the screening visit are NOT excluded
ENTRECTINIB EXCLUSION CRITERIA: Prior treatment with the following anti-neoplastic therapies within the following time frame:\r\n* Any prior treatment with entrectinib\r\n* Any prior treatment with TRK, ROS, or ALK inhibitors\r\n* Radiotherapy within weeks prior to enrollment\r\n* Whole brain radiotherapy within weeks prior to enrollment, or stereotactic radiation to the brain within week prior to enrollment\r\n* Receipt of any cytotoxic chemotherapy, biologic agent, or investigational agent within weeks prior to the first dose of study drug
Subjects must have completed their most recent drug therapy directed at multiple myeloma in the following timeframes: \r\n* Chemotherapy, biological therapy, immunotherapy, or an investigational therapy at least weeks prior to starting DSb\r\n* Corticosteroids at least weeks prior to starting DSb, except for a dose equivalent to dexamethasone of >= mg/day\r\n* Nitrosoureas, nitrogen mustards, mitomycin C, or monoclonal antibodies at least weeks prior to starting DSb\r\n* Autologous stem cell transplantation at least weeks prior to starting DSb\r\n* Allogeneic stem cell transplantation at least weeks prior to starting DSb, and these subjects must also NOT have moderate to severe active acute or chronic graft versus host disease (GVHD)\r\n* Previous and concurrent use of hormone replacement therapy, the use of gonadotropin-releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within weeks before study drug treatment
Subjects who have required plasmapheresis and exchange less than weeks prior to initiation of therapy with DSb
Phototherapy (PUVA): weeks
Retinoids: weeks
Low dose methotrexate: weeks
weeks or more since end of previous systemic or radiation treatment ( weeks or more for bevacizumab plus interferon-alfa)
Patients treated with chemotherapy for lymphoma within weeks of protocol enrollment (including Rituxan)
Patients with lymphoma must ideally have at least stable disease from last therapy, however if the PI or LAI believes there is a high likelihood of response to induction chemotherapy (etoposide, prednisone, vincristine sulfate, cyclophosphamide, doxorubicin hydrochloride-fludarabine phosphate+/-rituximab [EPOCH-F+/-R]), then the patient may be enrolled on the induction phase arm; for enrollment on the research phase arm, the patient must have at least stable disease which is defined as:\r\n* Absence of disease progression for at least weeks after previous therapy or weeks after autologous transplantation\r\n* Patients who are less than weeks from previous therapy or weeks from autologous transplantation may participate in the study at the discretion of the PI or LAI as long as they do not have progressive disease
Radiographical documentation of metastatic disease with imaging up to weeks prior to enrollment
Completion of definitive therapy - weeks prior to enrollment; there are no specific limitations on which treatment modalities can be used in the definitive setting (e.g. the use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at least weeks prior to enrollment
Completion of definitive therapy for oligometastatic disease greater than weeks prior to enrollment
Receipt of previous systemic drug therapy for at least weeks and withdrawal from treatment due either to intolerability or to radiographic disease progression. If treatment was withdrawn due to intolerability manifested as a Grade or event by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE v.), less than weeks of continuous prior administration prior to withdrawal is acceptable (see also Exclusion Criterion #).
Patients must be ? weeks since major surgery, radiotherapy, chemotherapy ( weeks if they were treated with nitrosureas) or biotherapy/targeted therapies.
Required wash out periods for prior therapy (for cohort B):\r\n* Topical therapy: weeks \r\n* Chemotherapy: weeks\r\n* Radiotherapy: weeks\r\n* Other investigational therapy: weeks\r\n* Rituximab: weeks
Patients on alemtuzumab within weeks prior to consenting
Biologic therapy (including antibodies [other than trastuzumab], immune modulators, cytokines) within weeks before the first dose of study treatment; Note: there is no washout period required for trastuzumab
Patients who have completed previous therapies -weeks prior to (or within drug half lives) enrollment on study. Radiation therapy wash out period will be weeks. This includes an exception of patients with metastatic GIST tumors who are taking maintenance imatinib mesylate therapy. These patients are allowed to remain on imatinib mesylate therapy up to enrollment in this study.
Radioimmunotherapy within weeks
Specific KS therapy, including cytotoxic chemotherapy but not including HAART, within the past weeks ( weeks if the therapy was bevacizumab)
Patients must be at least weeks from radiation therapy; additionally, patients must be at least weeks from nitrosoureas, weeks from temozolomide, weeks from procarbazine, weeks from vincristine and weeks from last bevacizumab administration; patients must be at least weeks from other cytotoxic therapies not listed above and weeks for non-cytotoxic agents (e.g., interferon, tamoxifen) including investigative agents; all toxicities from prior therapies should be resolved to Common Terminology Criteria for Adverse Events (CTCAE) =< grade (except for toxicities such as alopecia, or vitiligo)
History of tocilizumab therapy within prior weeks
Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within weeks (or weeks if patient experienced disease progression on the prior treatment)
Prior T-cell or other cell-based therapies within weeks (or weeks if patient experienced disease progression on the prior treatment)
Receipt of a live vaccine within weeks prior to randomization; efficacy and/or safety of immunization during periods of B-cell depletion have not been adequately studied; it is recommended that a patients vaccination record and possible requirements be reviewed; the patient may have any required vaccination/booster administered at least weeks prior to the initiation of study treatment; review of the patients immunization status for the following vaccinations is recommended: tetanus; diphtheria; influenza; pneumococcal polysaccharide; varicella; measles, mumps and rubella (MMR); and hepatitis B; patients who are considered to be at high risk for hepatitis B virus (HBV) infection and for whom the investigator has determined that immunization is indicated should complete the entire HBV vaccine series at least weeks prior to participation in the study
Recent history of allergen desensitization therapy within weeks of starting study treatment.
Intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose in this trial, or
Able to begin study therapy within weeks (+/- week) of final IV/IP chemotherapy
? weeks for phototherapy
Use of Avastin in the preceding two weeks or planned use in the forthcoming two weeks and VEGF inhibitors within + days of treatment
Recovered from acute toxicities of other treatments (? Grade ). All other MDS treatments discontinued at least weeks prior to treatment except epoetin alpha (Procrit) weeks.
Enrollment and randomization within weeks of initial cholecystectomy
Off calcineurin inhibitors for at least weeks
Prior treatment with SERMs or SERDs within weeks of first GT dose
A minimum of two weeks of VMS diary recording prior to SGB
Blood counts performed within weeks prior to starting study therapy must have hemoglobin >= g/dL
Biopsy-proven KS involving skin (with or without visceral involvement) without need for urgent cytotoxic therapy; there should be no evidence of improvement in KS in the weeks immediately prior to study enrollment
Any of the following therapies prior to pre-registration:\r\n* Chemotherapy =< weeks\r\n* Immunotherapy =< weeks\r\n* Biologic therapy =< weeks; Note exception: prior viral and/or gene therapy are exclusion criteria\r\n* Radiotherapy =< weeks
weeks from procarbazine
The subject has received systemic chemotherapy (including investigational agents) within weeks, or biological agents (antibodies, immune modulators, cytokines, or vaccines) within weeks, or hormonal anticancer therapy within weeks before the first dose of study treatment (within weeks in the case of fulvestrant) (vaccines, such as flu shot or, pneumovax are not exclusions)
Therapy must begin between days ( weeks) and days ( weeks) after the most recent brain tumor surgery (resection or biopsy)
Patients must be at least weeks from prior thoracotomy (if performed)
Use of clobetasol ointment intra-orally at any time during the last weeks period
Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) must have been completed at least weeks before study drug administration, and all adverse events have either returned to baseline or stabilized\r\n* For the fourth cohort, ipilimumab at mg/kg must have been completed not less than weeks prior to initiation of BMS-; ipilimumab at mg/kg must have been completed not less than weeks prior to initiation of BMS-\r\n* All drug related toxicities must have resolved to grade or less, and patients must be off steroids for at least weeks\r\n* Patients in the fourth cohort who required infliximab or other immune suppressants including mycophenolic acid will be excluded\r\n* For the fifth cohort, ipilimumab at mg/kg or mg/kg must have been completed not less than weeks prior to initiation of BMS-; all drug related toxicities must have resolved to grade or less, and patients must be off steroids for at least weeks and any other immune suppressant such as mycophenoloc acid or infliximab for at least weeks\r\n* Patients in the fifth cohort who experienced grade -,neurologic or ophthalmologic side effects or any other grade side effect other than liver, pancreatic, gastrointestinal (GI), endocrine, pulmonary or skin related will be excluded
Intravesical therapy within weeks prior to beginning study treatment with the exception of:
Patients must be enrolled within weeks of primary surgery or within weeks after diagnosis of recurrent disease
Other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: weeks ( weeks with documented disease progression)
Anticancer treatment within weeks of study drug or weeks if patient experienced disease progression on prior treatment
Cohort : Subjects with high-grade Ta or any grade T papillary disease (without CIS) whose disease is determined to be refractory or relapsed within months of the last dose of adequate BCG treatment. For eligibility and cohort assignment, months is defined as weeks i.e., weeks ( months) plus an additional weeks to accommodate scheduling variations and for diagnostic work-up and months is defined as weeks i.e., weeks ( months) plus an additional weeks to accommodate scheduling variations and for diagnostic work-up. For subjects enrolling in Cohort : The investigator documents he/she would not treat the subject with additional BCG at the time of study entry.
The last dose of trastuzumab must have been given > weeks and ? year ( days) from enrollment
Treatment with -? reductase inhibitors (finasteride, dutasteride) within weeks of randomization;
Participant must have received ruxolitinib therapy for at least weeks and be currently on a stable dose of >= mg BID of ruxolitinib for >= weeks prior to the st dose of navitoclax, ECOG of ,, or .
Less than weeks interval since the date of final surgery or less than weeks from completing radiotherapy (whichever occurs last) at date of randomization.
weeks or more have passed since completion of radiotherapy at day of randomization and weeks interval since the date of final surgery have passed.
Wash out periods prior to Day of Cycle : At least three weeks since the last chemotherapy (six weeks in some particular cases) and At least four weeks since the last radiotherapy (RT) > Gy) and At least one week since the last hormonal therapy and At least two weeks since the last biological/investigational therapy
Use of hydroxyurea within weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Use of hydroxyurea within weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
fevers higher than .F or .C for >= weeks without other evidence of infection
Applies only for patients without the deletion q .; patients must have failed treatment with an erythropoietic growth factor, or have a low probability of response to rhu-erythropoietin; patients with low probability of response to rhu-erythropoietin or prior erythropoietin failures are defined as follows:\r\n* Prior erythropoietin failure-requires a minimum trial of >= , units epoetin alfa/week x weeks or equivalent dose of darbepoetin alfa for weeks with failure to achieve transfusion independence in dependent patients or a failure to achieve a >= g rise in hemoglobin sustained for >= weeks in non-transfusion dependent patients\r\n* Low erythropoietin response profile-rhu-erythropoietin and epoetin alfa-nave patients receiving >= U packed (p)RBC/month for a minimum of weeks, and serum erythropoietin > mU/mL in the weeks prior to randomization for a hemoglobin < . g/dL
Prior treatment will be permitted including surgery (>= weeks), cytotoxic chemotherapy (maximum of prior regimens); radiation, interferon, targeted growth factors (>= weeks); and prior treatment with octreotide, will be allowed
At least weeks from surgical resection and weeks from end of radiotherapy prior to enrollment in this study, unless relapse is confirmed by tumor biopsy or new lesion outside of radiation field, or if there are two MRIs confirming progressive disease that are weeks apart.
Subjects must have received their last chemotherapy, non-anti-VEGF biologic, or investigational therapy at least weeks prior to enrollment, weeks if the last regimen included BCNU or mitomycin C, and weeks if the last regimen was an anti-VEGF therapy
No prior systemic therapy for CLL or SLL including chemotherapy or immunotherapy (e.g., monoclonal antibody-based therapy), radiation therapy, within weeks of enrollment; no prior carmustine (BCNU) or mitomycin C within weeks of enrollment; no radioimmunotherapy within a year of enrollment; no corticosteroids administered within weeks prior to study entry, except for maintenance therapy (=< prednisone mg daily or equivalent) for a non-malignant disease
EXCLUSION FOR TREATMENT: Recent prior therapy: systemic chemotherapy less than weeks prior to infusion or apheresis ( weeks for clofarabine or nitrosoureas for apheresis) or radiation therapy less than or equal to weeks prior to apheresis; exceptions:\r\n* There is no time restriction in regard to prior intrathecal chemotherapy provided there is complete recovery from any acute toxic effects of such\r\n* Subjects receiving hydroxyurea or oral maintenance chemotherapy may be enrolled provided there has been no increase in dose for at least weeks prior to starting apheresis or treatment\r\n* Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least weeks prior to starting apheresis or treatment\r\n* Subjects must have recovered from the acute side effects of their prior therapy, such that eligibility criteria are met; cytopenias deemed to be disease-related and not therapy-related are exempt from this exclusion
Prohibited treatments and/or therapies\r\n* Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses); however, use of corticosteroids is allowed for the treatment of immune related adverse events (irAEs), or adrenal insufficiency\r\n* Any non-oncology vaccine therapy used for prevention of infectious diseases within weeks prior to first dose of ipilimumab/nivolumab\r\n* Prior treatment with a CD agonist, ipilimumab or other CTLA inhibitor\r\n* Prior investigational agents within weeks prior to first dose of ipilimumab/nivolumab\r\n* Prior therapy with any anti-cancer agents including chemotherapy, adjuvant chemotherapy, immunosuppressive agents, surgery or radiotherapy within weeks prior to first dose of ipilimumab/nivolumab
Within weeks prior to the first dose of CDX- of any biologic treatment or IV chemotherapy.
Inactivated vaccines should precede the initiation of any study regimen and/or standard adjuvant therapy by at least weeks, but preferably weeks or longer
Was treated for at least weeks with MK- before discontinuing therapy
Anticipated need for systemic chemotherapy within weeks before apheresis and infusion of CART-meso cells
No chemotherapy, radiation, biologics or immunotherapy within weeks prior to registration ( weeks if last received carmustine [BCNU] or mitomycin C)
The patient must not have required a paracentesis within the preceding weeks nor be projected to require a paracentesis within the next weeks.
Hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment
Patients must be >= weeks (minimum) to weeks (preferred) from prior myelosuppressive chemotherapy (primarily lenalidomide) to facilitate mobilization
Women and men of reproductive potential should agree to use two effective means of birth control\r\n* For women, contraception should continue for weeks after the last dose of nivolumab and weeks after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body\r\n* For men, contraception should continue for weeks after nivolumab and weeks after dasatinib
For participants previously treated with first generation anti-androgens (ie, flutamide, nilutamide, or bicalutamide), discontinuation of flutamide or nilutamide therapy must occur greater than (>) weeks (> weeks for bicalutamide) prior to start of study drug with no evidence of an anti-androgen withdrawal response (no decline in serum PSA)
Stable supplement usage for > weeks prior to starting and agrees not to change while on this study
Prior antitumor therapy within weeks of enrollment (with the exception of somatostatin analogs)
Investigational compound within weeks of enrollment
Started less than weeks prior to randomisation AND Prostate Specific Antigen (PSA) is stable or falling. The weeks starts from whichever of the following occurs earliest: first dose of oral anti- androgen, LHRHA, or surgical castration.
Steroid dose increased in the most recent two weeks
Requirement of permanent or frequent (i.e., once per week) external drainages within two weeks prior to randomization
Stable dose of glucocorticoids for weeks prior to enrollment
In the opinion of the invesgator likely to complete ? weeks of treatment.
Subjects must be entered no more than weeks postoperatively
At least weeks must have elapsed from the use of androgen receptor antagonists (e.g., bicalutamide, flutamide, nilutamide); -alpha reductase inhibitors (e.g., dutasteride, finasteride, aminoglutethimide); estrogens; ketoconazole and other anti-cancer pharmacologic therapy prior to enrollment
Cholangitis that required treatment or intervention within weeks of study enrollment
Last dose of chemotherapy or experimental therapy more than weeks ( weeks in the case of nitrosourea) prior to enrollment date; weeks if the last therapy was received as part of a phase or exploratory investigational new drug (IND) trial; last surgery more than weeks prior to enrollment; core biopsies or fine need aspiration (FNA) will not require any waiting period
Patients must be at least weeks from last radiation dose; patients must be at least weeks from last chemotherapy, targeted therapy, or biologic therapy (exception allowed for a week washout for patients who were on chemotherapy at less than a standard of care dose, as long as all other eligibility criteria are met); patients must be at least weeks from last surgical procedure and recovered from all post-operative complications
Participants may have had up to two previous cytotoxic therapeutic regimens provided these were discontinued >= weeks before enrollment; the use of antineoplastic agents for non-cancer therapy (i.e. colitis, rheumatoid arthritis) may be allowed provided the patient has been on a stable dose without toxicities greater than grade
Patients must have completed WBRT > weeks prior to enrollment to limit cases of pseudoprogression; however if new lesions are noted < weeks but > weeks prior to enrollment, those patients are eligible
At the time of registration, patient must be at least weeks from prior vincristine, weeks from prior procarbazine, and weeks from other prior cytotoxic chemotherapy
Use of -alpha reductase antagonist (i.e. finasteride, dutasteride) within weeks prior to randomization
Use of antiandrogen (e.g. flutamide, nilutamide, bicalutamide) within weeks prior to randomization
Completion of preoperative systemic chemotherapy and HER-directed treatment consisting of at least cycles of chemotherapy with a total duration of at least weeks, including at least weeks of trastuzumab and at least weeks of taxane-based therapy
Up to one cycle of prior therapy is allowed (maximum of mg total dexamethasone [dex] [or equivalent amount of prednisone]), days of melphalan, doses of cyclophosphamide and/or doses of Velcade; at least weeks (wks) has to have had passed since last dose of melphalan, weeks since last Velcade or glucocorticoid dose
Treatment with antiandrogens (e.g., bicalutamide, flutamide, or nilutamide) within weeks of enrollment (day visit)
If taking systemic therapy for cGvHD at the time of enrollment, must be on a stable or tapering schedule in the preceding weeks (extracorporeal photopheresis has to be stopped at least by weeks before enrollment)
Interval >= weeks and =< weeks from the completion of radiochemotherapy
Brain metastases (except if all known lesions were previously treated with surgery or stereotactic radiosurgery and lesions, if still present, are confirmed stable for >= weeks prior to randomisation or if no longer present are confirmed no evidence of disease for >= weeks, and are asymptomatic with no corticosteroid requirements for >= weeks prior to randomisation, and no enzyme inducing anticonvulsants for >= weeks prior to randomisation
Grade infection within weeks of first dose romidepsin plus ICE.
Patients on Octreotide LAR at a fixed dose of mg or mg at - weeks intervals for at least weeks prior to randomization in the study.
Patients must have progressive disease based on RECIST Criteria, Version . while receiving an uninterrupted fixed dose of Octreotide LAR (- mg/- weeks). Disease progression must be centrally confirmed. In order to make the assessment, two CT (or MRI) scans are required. The oldest scan must not be older than years from the date of randomization. The most recent scan must not be older than weeks from the date of randomization. Both scans must be obtained while the patient is receiving the same fixed dose of Octreotide LAR (- mg/- weeks) with the following exceptions; ) it is acceptable if the oldest scan is obtained within weeks of the patient receiving a fixed dose regimen of Octreotide LAR (- mg/- weeks); AND ) it is acceptable for either scan to be obtained before or during the time a patient receiving a fixed dose of Octreotide LAR has switched to an equivalent dose of short acting Octreotide for up to weeks in order to obtain an OctreoScan, provided the patient returns to the Octreotide LAR fixed dose after the OctreoScan has been obtained.
Treatment with > mg Octreotide LAR at - weeks intervals within weeks prior to randomization in the study.
prior immunotherapy, or prior investigational agents should be washed out weeks before apheresis and must be completed weeks prior to pre-infusion lymphodepletive chemotherapy.
Systemic corticosteroid or other immunosuppressive therapy should be washed out weeks before apheresis and must be completed at least weeks prior to pre-infusion lymphodepletive chemotherapy
Patients in cohort may not receive chemotherapy, monoclonal antibodies (other than RANK-ligand inhibitors being used for bone protection), HER targeted therapy such as lapatinib, or radiation therapy in the weeks before the first injection, during the injection period or for at least weeks after the last injection; in cohort , patients may not receive cytotoxic chemotherapy or radiation therapy in the weeks before the first injection, during the injection period or for at least weeks after the last injection; patients may have received prior radiation including for brain metastases
Prior sunitinib and everolimus will be permitted; a wash-out period of weeks is required prior to first dose on this study
Treatment with other FAP directed drug therapy (including sulindac or celecoxib, fish oil) within weeks of study enrollment.
The first dose of study treatment must be at least three weeks since prior chemotherapy, including sunitinib or everolimus
Radioimmunotherapy (i.e. Zevalin) within weeks of enrollment
Nitrosurea: ? weeks
Patients must have adequate organ function to undergo local therapy weeks +/ - weeks prior to randomization per investigator discretion and institutional guidelines
Have not received anti-cancer therapy for at least weeks prior to study entry, with the exception of low dose ara-C (LDAC) given as subcutaneous injections (no less than days prior), hydroxyurea or anagrelide (no less than hours prior), TKI (no less than days prior), and interferon (no less than weeks prior)
Patients must begin temozolomide chemotherapy no sooner than weeks and no later than weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than weeks and no later than weeks from the surgery
For patients previously treated with first generation anti-androgens (i.e., flutamide, nilutamide, or bicalutamide), discontinuation of flutamide or nilutamide therapy must occur > weeks (> weeks for bicalutamide) prior to start of study drug with no evidence of an anti-androgen withdrawal response (i.e., no decline in serum PSA).
KS therapy other than HAART within weeks
Must have completed last cycle of second-line induction no less than weeks ( days) and no greater than weeks ( days) prior to randomization.
ASCT within weeks (i.e., ASCT is allowed if it occurred before enrollment in Study NEOD- or after completion of Study NEOD- if it was at least weeks before Month -Day of this study)
Discontinuation of all cytotoxic chemotherapy and anti-CD antibody therapy for ? weeks, alemtuzumab for ? weeks, targeted therapy for ? weeks, and investigational therapy for ? weeks before enrollment (Phase b) or randomization (Phase ). For individuals with relapsed CLL most recently treated with B-cell receptor (BCR) pathway inhibitors who, in the opinion of the investigator, will not tolerate waiting weeks, a washout period of > half-lives is allowed. If on a systemic corticosteroid, the dose must be stable for the previous weeks.
Biologic therapy (e.g., antibodies): ? weeks
Minimum of weeks from the first dose of antiCTLA- and weeks from the last dose
Monoclonal based therapies within weeks and all other immunotherapy within weeks prior to first dose of study treatment.
There should be no evidence for improvement in KS in the months prior to study enrollment, unless there is also evidence for progression of KS in the weeks immediately prior to enrollment
Receiving any cancer therapy within weeks of first dose (including surgery, and/or tumor embolization) Note: the following are allowed: Corticosteroids to control systemic or local symptoms, up to a dose of mg prednisone or equivalent daily and stable for at least days prior to enrollment. Subjects with prostate cancer may remain on GnRH agonists. Other hormonal therapies (e.g., bicalutamide, abiraterone and enzlutimide) for prostate cancer must be stopped weeks prior to enrolment. Note: the following are NOT allowed: Chemotherapy regimens with delayed toxicity within the last weeks. Nitrogen mustards, Melphalan, Monoclonal antibody or Nitrosourea within the last weeks.
weeks from procarbazine
The last dose of previous therapy targeting RET kinase must be given at least weeks prior to the first dose of ponatinib
Patients must have recovered and healed from the effects of any prior surgery, must have received prior chemotherapy at least weeks prior to dosing with adequate recovery of white blood cell (WBC) and platelet counts, and at least weeks must have elapsed from the completion of radiotherapy, unless there are new lesions appearing on imaging within this weeks frame
There should be no evidence for improvement in KS in the months prior to study enrollment, unless there is evidence for progression of KS in the weeks immediately prior to study enrollment
Less than weeks since prior treatment; or weeks if patient experienced disease progression on the prior treatment
Schedule can accommodate both of the following: doses of mirvetuximab soravtansine administered weeks apart and surgery within weeks of last dose of NAC
Able to begin extension study within weeks of receiving th cycle of DI-Leu-IL
Off all myelofibrosis-related investigational or standard agents (except for ruxolitinib) for at least weeks prior to study enrollment and recovered from all toxicities; if patient is already on ruxolitinib for a minimum of weeks prior to study enrollment, patient can proceed to mobilization and collection
Subjects must have the following minimum wash-out and adverse event (AE) recovery period from previous treatments without treatment between documentation of relapse/progression and enrollment of specifically:\r\n* >= weeks for local radiation therapy\r\n* >= weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least weeks\r\n* >= weeks for anti-cluster of differentiation (CD) or anti-cytotoxic T-lymphocyte-associated protein (CTLA-) (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n* >= weeks from resolution (i.e., =< grade or at baseline) from AEs due to procedures performed or therapeutic agents administered\r\n* >= weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox, and therapeutic doses of oral corticosteroids (physiologic replacement doses of oral corticosteroids are allowed, topical corticosteroids are allowed)\r\n* >= weeks for phototherapy\r\n* >= week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
Able to initiate study treatment at least weeks but no more than weeks after completion of salvage therapy
All patients must be off previous chemo- and/or radiotherapy for at least three () weeks prior to entrance into the study and have recovered from any toxic effects induced by such treatment(s); no nitrosourea type drug or ipilumimab treatments are permitted within the last six () weeks prior to enrollment. No major surgery within days of enrollment. Patients may continue to receive anti-estrogen/steroid therapy that has been initiated at least eight weeks prior to enrollment in the study.
within weeks prior to the first dose of KTN, or
Adequate recovery from prior systemic or local melanoma therapy; no systemic anticancer therapy in the weeks and no ipilimumab in the weeks from planned vemurafenib administration; no radiation therapy in weeks prior to date plan to initiate vemurafenib treatment and no surgery in weeks prior to date of planned vemurafenib administration
Use of a first-generation anti-androgen such as bicalutamide within weeks of study drug dosing, or flutamide within weeks of study dosing
Administration of conventional chemotherapy within weeks of enrollment date. In the event that subjects have received chemotherapy > weeks from the date of enrollment, they may be included provided they have recovered from the associated non-hematological toxicities to ? grade .
Use of -alpha reductase antagonist (i.e. finasteride, dutasteride) or antiandrogen (i.e. flutamide, bicalutamide) within weeks of day of protocol therapy
Prior treatment with bortezomib (Velcade) is acceptable with a wash-out of weeks
Fevers >. F or night sweats for more than weeks without evidence of infection.
Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide), -? reductase inhibitors (finasteride, dutasteride), estrogens, chemotherapy, or biologic therapy within weeks of Day visit
Have had a loco-regional procedure for the treatment of hepatocellular carcinoma (such as a percutaneous, trans-arterial, or radio-ablative procedure) less than weeks prior to beginning protocol therapy. Protocol therapy may begin a minimum of weeks after such a procedure provided the following criteria are met:
Recovery from effects of recent surgery, radiotherapy, or chemotherapy\r\n* At least weeks out from their last dose of radiation therapy\r\n* At least weeks post-operative (op) from any major surgical procedure\r\n* At least weeks out from their last dose of chemotherapy and/or biologic/targeted therapy
Received nitrogen mustard agents, melphalan, or BCNU therapy within weeks prior to the first study dose
Have had their last administration of study treatment (siltuximab or placebo) less than weeks (window of plus weeks) prior to first dose
Treatment with anti CD therapy within weeks, or alemtuzumab within weeks, or any cytotoxic antileukemia therapy within weeks, Ibrutinib or Idelalisib within week prior to the first administration of the trial drug.
- weeks since completion of combined modality therapy
Biologic therapy (e.g., antibodies): ? weeks.
Patients must have fully recovered from the effects of any prior surgery, chemotherapy or radiation therapy; a minimum time period of weeks should elapse between the completion of radiation therapy for recurrent/metastatic disease and enrollment in the study; a minimum of weeks should elapse between the completion of chemotherapy or any experimental therapy and enrollment in the study; a minimum of weeks should elapse between prior major surgery (such as open biopsy or significant traumatic injury) and enrollment in the study; a minimum of weeks should elapse between prior minor surgical procedures (such as chemotherapy infusion port placement or core visceral organ biopsy) and enrollment in the study
cytotoxic therapy within the past weeks ( weeks for BCNU/CCNU)
Treatment with nitrosoureas, such as carmustine (BiCNU), nitrogen mustard agents, or melphalan, within weeks of first dose of elotuzumab.
Antiviral treatment for influenza in weeks prior to randomization
Intravesical chemo- or biologic therapy within weeks of first treatment
Alkaline phosphate =< . x ULN (within four weeks prior to the study)
Minimum weeks since prior systematic treatment or phototherapy
Histologically confirmed breast cancer for which chemotherapy with AC (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting (AC may be administered every or weeks, and may be preceded by or followed by paclitaxel planned to be given at mg/m^ weekly or mg/m^ every - weeks, per standard treatment plan) OR metastatic prostate adenocarcinoma for which docetaxel will be administered (between mg/m^ to mg/m^ every weeks)
Severe anemia (hemoglobin < g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have chemotherapy within past weeks).
Expected to undergo therapeutic thoracentesis in the next weeks.
Subjects must have the following minimum wash-out from previous treatments and without treatment between documentation of relapse/progression and enrollment:\r\n* >= weeks for local radiation therapy\r\n* >= weeks for low dose ( Gy or less) total skin electron beam therapy (TSEBT)\r\n* >= weeks for systemic cytotoxic anticancer agents, anticancer investigational agents that are not defined as immunotherapy, or for tumor-targeting monoclonal antibodies (mAbs) with the exception of alemtuzumab for which the washout is at least weeks\r\n* >= weeks for anti-CD or anti-CTLA- (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)\r\n* >= weeks from resolution (i.e., < grade or at baseline) from adverse event (AE)s due to procedures performed or therapeutic agents administered\r\n* >= weeks for retinoids, interferons, vorinostat, romidepsin and denileukin diftitox\r\n* >= weeks for doses of systemic corticosteroidsgreater than mg/day of prednisone or equivalent; patients who are on physiologic doses of corticosteroids (prednisone equivalent mg/day or less) may participate, however, they must be on a stable dose for at least weeks before enrollment; patients who are on low or moderate potency topical corticosteroids may participate if they are on a stable dose for at least weeks before enrollment; inhaled corticosteroids are acceptable; local injections of corticosteroids are acceptable; all corticosteroids will be reported as concomitant medications\r\n* >= weeks for phototherapy\r\n* >= week for topical therapy (including retinoid, nitrogen mustard, or imiquimod)
Recent history of allergen desensitization therapy within weeks of starting study treatment.
Anticipated to undergo pancreatectomy in >= weeks from enrollment
The presence of fatigue for at least weeks
Within weeks prior to study enrollment the patient must be on a stable dose of medications for management of chemotherapy-induced peripheral neuropathy (CIPN) symptoms; for at least weeks prior to enrollment stable dose is defined as: \r\n* No change in drug class \r\n* Increases or decreases that are less than or equal to % of the total dosage; all drug classes are allowed
Use of any exogenous estrogen within the preceding four weeks
If on medication for anxiety, stable dose of medications for management of anxiety symptoms for at least six weeks prior to enrollment with no plans to change meditations in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable
On AI therapy for at least weeks
Patients who have had chemotherapy within three () weeks or radiation within four () weeks; patients may not receive additional chemotherapeutic agents while on this study
Able to commit to LOFT training times/week for weeks
Patients should describe fatigue as being present for a minimum of weeks
Initiation of extracorporeal pheresis (ECP) therapy within weeks prior to enrollment
Stable dose of glucocorticoids for weeks prior to enrollment
Low-dose IL- therapy in the weeks prior
Severe anemia (hemoglobin [Hb] < g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within the last weeks)
Histologically proven stage -III invasive carcinoma of the breast\r\n* Patients must have completed primary surgical resection at least weeks prior to enrollment, radiation at least weeks prior to enrollment and/or cytotoxic chemotherapy at least weeks prior to enrollment in the study
An expected hospital stay of - weeks or longer
Patients who do not have at least weeks before receiving local control
Initiation of extracorporeal pheresis (ECP) therapy within weeks prior to enrollment
Use of muscle relaxant medications such as cyclobenzaprine within four weeks of enrollment and during course of the study, unless the regimen of muscle relaxants is stable for weeks prior to enrollment and does not change for the duration of the study
This disease assessment is required for eligibility and preferably should be done within weeks prior to enrollment, but must be done within a maximum of weeks before enrollment.
Stable hormone status for weeks prior to aspiration and willing to maintain same status while on study; this means no change in an oral or non-oral hormonal contraceptive within the past weeks prior to RPFNA
Systemic corticosteroid or other immunosuppressive therapy should be washed out weeks before apheresis and must be completed at least weeks prior to pre-infusion lymphodepletive chemotherapy.
Completed definitive local therapy and have scans, ? weeks after completion of definitive local therapy confirming either Complete Response (CR), Partial Response (PR), or Stable Disease (SD). If salvage neck dissection or salvage laryngectomy is not performed, patients must initiate study treatment within weeks of the screening scans and within weeks after completion of the definitive local therapy. If salvage neck dissection or salvage laryngectomy is performed, patients must initiate study treatment within weeks of screening scans and within weeks after completion of definitive local therapy.
Cranio-spinal radiation ? weeks NOTE: Subjects in Arm (ie, with DIPG) must be ? weeks and ? weeks after standard focal radiotherapy (dose of to cGy and maximum dexamethasone of mg/m/day)
Participants must not have pneumonia or acute bronchitis for at least weeks prior to enrollment
Use anti?platelet agents within two weeks of anticipated sigmoidoscopy
Use of anti?coagulants within two weeks of anticipated sigmoidoscopy
Treatment with Sandostatin long-acting release (LAR) within weeks, subcutaneous (SQ) Octreotide within hours, or Lanreotide injection within weeks of Ga- DOTATOC PET/CT (+/-%)
Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least weeks and off chemotherapy for weeks for the initial baseline FES
Use of tamoxifen, Faslodex, diethylstilbestrol (DES) or any other ER blocking agent < weeks or chemotherapy < weeks prior to imaging scan
Chemotherapy (taxanes) or Radium- alpha-particle treatment within the last weeks prior to imaging
Monoclonal based therapies within weeks (excluding cetuximab) and all other immunotherapy within weeks prior to first dose of study treatment.
Ureteral stint present or removed within six weeks
Need to be able to undergo atorvastatin treatment for a minimum of weeks but no more than a maximum of weeks prior to surgical staging
Willing to be seen at baseline, weeks, weeks, and weeks for the study time points
no CHR by weeks (whether lost or never achieved)