[c09aa8]: / clusters / 9knumclustersv2 / clust_317.txt

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Subjects must be at least weeks post last dose of temozolomide
A patient who has had a lumpectomy with positive margins as part of their treatment for a current DCIS diagnosis is eligible (post-excision mammogram required at enrollment to establish a new baseline)
POST-OPERATIVE REGISTRATION/RANDOMIZATION CRITERIA
Patients should not be randomized less than weeks post-surgery but will not be acceptable for randomization more than weeks post-surgery
Patients must have eligibility confirmed by rapid central imaging review on APECB; standard whole brain magnetic resonance imaging (MRI) with and without contrast (gadolinium) and spine MRI with contrast (gadolinium) must be performed at the following time points:\r\n* Pre-operative to include an MRI of the brain with and without contrast (including post-contrast three-dimensional [D] T-weighted image [TWI] and post-contrast fluid-attenuated inversion recovery [FLAIR])\r\n* Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may be obtained if pre-operative imaging is not possible or is suboptimal; pre-operative spine imaging is strongly preferred, due to the potential of post-operative sequelae, which could affect metastasis detection\r\n* Post-operative brain MRI within hours of surgery
GTR must be confirmed on post-operative imaging following the most recent surgery; submission of both pre-operative and post-operative MRIs is required for patients; if a second surgery is performed, submission of post-operative MRI is required and pre-operative MRI is required only if obtained; all sequences obtained in the pre- and post-operative MR imaging are to be submitted to National Radiology Group (NRG) Oncology for study registration; imaging subsequent to enrollment must include pre and post gadolinium contrast-enhanced three-dimensional spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan and an axial T fluid attenuated inversion recovery (FLAIR) sequence; to yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE, or TFE axial MRI scan should use the smallest possible axial slice thickness not exceeding . mm; the post-operative MRI must be completed within sufficient time to permit step registration within days of the initial resection; these same conditions apply in the setting of a second surgical procedure, although if a second surgery is completed, step registration must still occur with days of initial surgery; computed tomography (CT) imaging is not required, but may be obtained if desired clinically, for instance to assess calcifications or hyperostosis
Unresolved post-surgical complications (eg, significant infection) with healing difficulties
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply: \r\n* They have recovered from the effects of surgery\r\n* A minimum of days have elapsed from the day of surgery to the day of registration step ; for core or needle biopsy, a minimum of days must have elapsed prior to registration step \r\n* Residual disease following resection of recurrent ependymoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than hours in the immediate post-operative period or at least weeks post-operatively, within days prior to consent; if the \within -hour after surgery\ scan is more than days before consent, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and consent, a new baseline MRI/CT is required on a stable steroid dosage for at least days
Planning to receive or have received autologous stem cell transplantation (ACST) per institutional standards as part of standard of care\r\n* Pre-ASCT participants may consent but will not be eligible to begin treatment until after ASCT, and will have to fulfill all inclusion and exclusion criteria before starting protocol\r\n* All participants must initiate day of protocol therapy within - days post stem cell reinfusion; study PI can grant exception for a patient to start as late as days post stem cell reinfusion with a reasonable justification for a delay (e.g. recovery from post -ASCT toxicity) and this will not be a protocol deviation, nor require an exception to be filled
Post-ASCT anti-lymphoma or investigational therapy; immediate post-ASCT consolidative radiation therapy is allowed as long as it occurs prior to initiation of study therapy; baseline imaging and pulmonary function tests (PFTs) must be performed after completion of radiation
Disease suitable for assessment by pre- and post-biopsies
Patients who have already started or received post-transplant maintenance or consolidation regimen
Post randomization exclusion will occur if the patient is found to have unresectable disease at laparotomy and therefore will not have the potential for the same post-operative complications
Clinically significant surgical intervention within days of the first dose of the IMP or with ongoing post-operative complications if more than days.
FOR PATIENTS ENROLLED IN THE EXPANSION COHORT: willingness to undergo mandatory biopsies (day -, approximately hours post end of irinotecan infusion and day , approximately hours post end of irinotecan infusion [= hours post end of VX-]); patients enrolled to this cohort should have tumors deemed easily accessible for biopsies with low likelihood of complication
Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
Relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
A diagnosis of post-transplant lymphoproliferative disease (PTLD)
Status post or more unmatched systemic therapy regimens for enrollment to group
At least weeks post-surgery prior to first dosing of study agent
Post exploratory thoracotomy must be done > weeks prior to study registration or patient did not have post exploratory thoracotomy.
Patients post hysterectomy and free from residual disease
Bladder post-void residual volume (PVR) of > mL.
Has residual thrombus post nephrectomy in the vena renalis or vena cava.
Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than - weeks post-operative.
Pregnant women; if patients are not status post bilateral salpingo-oopherectomy then pregnancy testing is required
Morphological or cytological features of myelodysplasia and/or post-chemotherapy aplasia on BM assessment;
Patient may not have received definitive salvage therapy for their post-transplant relapse; use of hydroxyurea is permitted
At least one RAI-avid lesion identified on the most recent radioiodine scan (a diagnostic, post-therapy, or post-ablation scan) prior to study registration; (both RAI-sensitive and RAI-refractory patients are eligible if at least one tumor with RAI avidity of any degree can be identified within these parameters)
Treatment plan that includes post-transplant maintenance therapy
Pathology must be a GBM, MGMT promoter region determined to be unmethylated and IDH wild type; >= % resection of contrast enhanced tumor on post operative MRI is required for randomization, otherwise treatment will occur on the ancillary arm
Patients should agree to serial liver metastases biopsy pre-treatment, post-radioembolization, and post-combination immunotherapy
Definitive cancer surgery is expected to be performed < days or more than weeks post study enrollment as determined by the enrolling physician
At least weeks post-completion of chemotherapy
Phase II mandatory pre-treatment and post-treatment fresh biopsies to determine PD-L and EGFR expression and other biomarkers
Patients having undergone recent resection of recurrent or progressive tumor will be eligible given all of the following conditions apply:\r\n* At least weeks ( days) have elapsed from the date of surgery and the patients have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent malignant glioma is not mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, a magnetic resonance imaging (MRI) should be done no later than hours in the immediate post-operative period or at least within weeks post-operatively, within days prior to registration; if the -hour scan is more than days before registration, the scan needs to be repeated; the patient must have been on a stable steroid dose for at least days prior to the baseline MRI; steroids may be initiated as clinically indicated once baseline imaging has been completed with a goal of titrating steroids as soon as clinically warranted
Must consent to study-specific biopsies at two separate timepoints: pre-treatment (Screening) and post-treatment (Day or EOS).
Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
Pre-operative or post-operative or planned radiation therapy for the current lung cancer
One or more evaluable or measurable lesions that have progressed based on RECIST ., within months of iodine therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or post-treatment scanning. These participants must not be eligible for possible curative surgery; or
Time to initiation of maintenance therapy: patients may start maintenance therapy as early as days post-transplant and up to days post-transplant; as long as they meet the following criteria:
Prior brain surgery is allowed, although a lesion situated in the operative bed would not be selected to receive an experimental dose of SRS treatment; SRS should be delivered - weeks post-surgery if the patient had a craniotomy for resection of a lesion; enrollment of a patient with the goal of performing SRS outside of the - post-craniotomy window is at the principal investigator (PI)s discretion
Patients who have already started or received multi-drug consolidation regimen post-transplant expect for patients receiving up to months of single agent lenalidomide maintenance
Patients must agree to pre- and post-treatment biopsies
Must be at least weeks post-operative
At least weeks post-surgery, and must be at least months post-radiation therapy, with resolution of related toxicities
Patients must be entered no more than weeks post operatively
Infants with post-menstrual age (PMA) < weeks
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > weeks from surgery\r\n* Residual disease following resection of recurrent malignant glioma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than hours in the immediate post-operative period or at least weeks post-operatively, within days prior to registration; if the -hour scan is more than days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least days
Patients are eligible to start on this protocol if they are between months to months post transplant
RAI-avid lesion on a radioiodine scan (a diagnostic, post-therapy, or post-ablation scans) performed =< months prior to registration, which suggests that therapy with I is justifiable in the judgment of the investigator
Absence of residual or disseminated disease as defined by the following criteria:\r\n* Minimal residual disease as determined by post-operative imaging preferably performed within hours of resection (and at most days post-surgery), i.e. gross total resection or residual disease of < . cm^ on post-operative imaging
Diagnostic imaging (pre and post contrast) must be forwarded to Dana-Farber Cancer Institute (DFCI) for central review to confirm eligibility
Participants for whom chemotherapy or intraoperative or post-operative radiation therapy is planned as part of the overall primary tumor treatment
Patients must be entered no more than weeks post operatively
Planned to receive either primary or post-operative CRT
Patients who receive post-transplant high dose cyclophosphamide
Bladder post-void residual volume of > mL.
All post-menarchal females must have a negative beta-HCG
Part patients must have recovered from the immediate post-operative period
Patients must have recovered from the immediate post-operative period
Patients who are less than weeks post-operative (op) after major surgery
A pre-operative magnetic resonance imaging (MRI) scan of the brain with and without contrast is required; NOTE: computed tomography (CT) scans are NOT sufficient for study eligibility\r\n* Post-operative head MRI scan with and without contrast (preferably within hours post-surgery); for patients who undergo stereotactic biopsy only, either a pre or post-operative MRI is sufficient; for patients with M and M disease, a post-op MRI is strongly encouraged, but not mandatory\r\n* Spinal MRI imaging with and without gadolinium is required within days of surgery if done pre-operatively or within days of surgery if done post-operatively; for posterior fossa tumors, pre-operative MRI scans are preferred
Patients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registration
Post-transplant lymphoproliferative diseases (often referred to as Epstein-Barr virus [EBV]-associated lymphomas)
FOR COHORT A ONLY: high-dose chemotherapy and AHCT must be planned; post-transplant maintenance therapy will not be permitted
- days post ASCT for non-Hodgkins lymphoma
Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion.
Post Void Residual (PVR) bladder volume > mL
Post resection serum cancer antigen (CA)- =< units/mL AND prior to any systemic treatment
SECOND COURSE PHASE (RETREATMENT PERIOD FOR POST-COMPLETE RESPONSE RELAPSE ONLY)
Confirmed diagnosis of PMF or post-PV/ET MF
Patients must be between - months post-transplantation at the time of study registration
Post surgery:\r\n* Must be a minimum of days from surgery before treatment may be initiated\r\n* Craniotomy site must be adequately healed and free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of registration\r\n* Post tumor resection, all patients must have a post-operative magnetic resonance imaging (MRI) done no more than hours after surgery; if post-op MRI was not completed within this time frame, a MRI must be completed > weeks (+/- days) after surgery, but before initiation of radiation treatment in order for an accurate assessment to be done post-radiation
Must have not received post-ASCT consolidation therapy.
Confirmed diagnosis of PMF in accordance, or Post-PV/ET MF
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They have recovered from the effects of surgery and be > days from surgery\r\n* Residual disease following resection of recurrent GBM or GS is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a CT/ MRI should be done no later than hours in the immediate post-operative period or at least weeks post-operatively, within days prior to registration; if the -hour scan is more than days before registration, the scan needs to be repeated; if the steroid dose is increased between the date of imaging and registration, a new baseline MRI/CT is required on a stable steroid dosage for at least days
Patients must be at least days post immunosuppressants prior to enrollment
Immune suppression; planned post-transplant immune suppression should include tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for alemtuzumab regimens and a second immune suppressant for ATG treated patients; other agents may be used if CN intolerance or toxicity occurs post-transplant
ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:
Patients having undergone recent resection of their glioblastoma (within weeks prior to registration) must have recovered from the effects of surgery; for CNS related core or needle biopsies, a minimum of days must have elapsed prior to registration\r\n* Residual disease following resection of recurrent glioblastoma is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, a post-operative or intra-operative MRI scan (or CT scan for patients with non-compatible devices) must be performed prior to registration and should be within hours post surgery (although hours would be optimum)
Time to initiation of maintenance therapy; patients may start maintenance therapy as early as days post-transplant and up to days post-transplant; as long as they meet the following criteria:
Lack of care-giver for the early (-day) post-transplant period
Participants need not have measurable disease; lesion may be primary or recurrent after prior surgery; patient tumor status:\r\n* Status post biopsy only and no further surgery planned\r\n* Status post resection with gross residual disease\r\n* Status post grossly complete resection but with margins positive or close (=< mm)\r\n* Status post biopsy and patient to have additional surgery and radiation
Concurrent investigational therapy delivered over the period of treatment or observation ( days post-RT) for dose limiting toxicity
Major surgical procedure or any radiation therapy within weeks of treatment, minimum rest period is days post surgery; maximum rest period days post surgery
Negative post-lumpectomy mammography if malignancy-associated microcalcifications were initially present
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY (COHORT ): Able to produce at least doses of fusion vaccine to be considered evaluable; patients who are unable to produce at least doses of fusion vaccine, but otherwise meet eligibility criteria for post-transplant immunotherapy, will be treated with pidilizumab (MDV) alone and will be replaced
MRD will be defined as detection in blood or marrow of:\r\n* Any leukemia specific marker (such as t[:] or t[:]) documented in the patients leukemia cells pre transplant on a post-transplant evaluation\r\n* A T-cell receptor (TCR) or immune globulin rearrangement known to be a disease marker for this patient post-transplant\r\n* A leukemia specific phenotype post-transplant at a level of >= .%\r\n* Mixed donor chimerism; OR\r\n* With no evidence of ALL or CLL/NHL post-HSCT (to be included in the phase II extension)
Patients who have undergone recent resection of recurrent or progressive tumor will be eligible as long as they have recovered from the effects of surgery. Evaluable or measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual measurable disease post-operatively, a MRI should be done no later than hours in the immediate post-operative period or - weeks post-operatively.
I.N.R. > . pre-operatively or > . post-operatively
Platelet count < , either pre-operatively or post-operatively
Pre- or post-operative radiotherapy
For Post-allo Part B: Treatment must begin at least days, but no more than days post-transplant.
For Post-allo Part B:History of veno-occlusive disease requiring defibrotide
Relapsed within three months post-transplant
Result from a post-operative contrast-enhanced brain MRI within hours after surgery or biopsy.
Post-transplant lymphoproliferative disorder
Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder
History of the following therapies in the post-transplant period:
Diagnosis of PMF or Post PV/ET-MF
For all subjects, prior post-operative adjuvant administration of anti-HER therapy is permissible.
AST and ALT < x ULN AND decreasing at two timepoints if patient is status/post (s/p) biliary stenting
have stable neurologic status post administration of local therapy (surgery or radiation) for a minimum of weeks following completion of the definitive therapy.
Residual disease following resection of recurrent tumor is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, an MRI should be performed:
No later than hours (h) in the immediate post-operative period; or
Placement of an intraperitoneal port at the time of surgery for anticipated use for adjuvant chemotherapy or management of post-operative ascites
Patients will be eligible to enter the study between - days post-transplant
Must have recovered from the immediate post-operative period
Residual disease following resection of recurrent tumor is not mandated for eligibility into the study; to best assess the extent of residual disease post-operatively, an MRI should be done no later than hours in the immediate postoperative period or at least weeks postoperatively, within days prior to registration; if the \within -hour of surgery\ scan is more than days before registration, the scan needs to be repeated
Post-operative MRI within hours of surgical resection
FCBP must agree to regular pregnancy testing during this timeframe; inclusion of FCBP requires two negative pregnancy tests prior to enrollment\r\n* Note: all women, regardless of age, should be considered FCBP unless they are surgically sterile (post hysterectomy, post bilateral oophorectomy, etc) or have been naturally post menopausal for >= consecutive months
Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as all of the following conditions apply:\r\n* They are > weeks from surgery\r\n* They have recovered from the effects of surgery\r\n* Evaluable or measurable disease following resection of recurrent tumor is mandated for eligibility into the study\r\n* To best assess the extent of residual disease post-operatively, an enhanced CT/MRI should be done no later than hours after surgery or it will need to be done - weeks post-operatively; if the hour scan is more than weeks from registration, the scan needs to be repeated
Availability of subject to be observed for up to months post-screening evaluation
Has the ability to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post procedure,
Post-operative MRI imaging with contrast is mandatory obtained for radiation therapy planning and must be days prior to the start of radiation therapy; enrolling sites are not mandated although highly encouraged to obtain thin-slice (< . mm) dimensional (D) axial T/FLAIR and T pre and post contrast sequences for planning purposes
Plans for moving to a new home or workplace during, pre-, or post-intervention period
Elective surgery anticipated during, pre-, or post-intervention period (e.g., breast reconstruction)
CHILD: Child has completed cancer treatment and is up to years post-treatment
Laboratory results within days prior to anticipated initiation of the first post randomization PLT transfusion:
>= months post active treatment
Residual disease of recurrent glioblastoma is not mandated for eligibility into the study. To best assess the extent of residual disease post-operatively, a post-operative MRI scan must be performed prior to registration and is recommended to be within hours post-surgery (although - hours would be optimum). Note: Patients who did have surgery with a post-operative contrast-enhanced scan falling outside the -week window prior to registration, must have a repeat MRI scan within days prior to registration.
A minimum of months post-surgical resection or biopsy (if applicable) and/or a minimum month post radiation treatment (if applicable)
Patient has not completed a Physician Orders for Scope of Treatment (POST) form
Within years post-treatment completion for lymphoma
Plan for post operative radiation therapy
Phase I: From months post-surgical treatment
Will also include, as a control, sickle cell patients being admitted for an elective procedure and post-operative surgery patients admitted after elective procedures
Patients that are between - years post treatment
Will be two weeks post-breast conserving surgery or three weeks post-breast conserving surgery with sentinel lymph node biopsy or four weeks post-mastectomy at the start of participation
As per medical record, =< months post-RP
=< days post diagnosis of a solid tumor or lymphoma
Greater than -months post diagnosis
Post HNC primary treatment
In early survivorship phase, defined as being post-surgery to ending of active treatment to months post active treatment for stage - breast cancer (BCA)
months post-treatment completion
Patients proposed post-operative treatment plan must include standard focal brain irradiation and temozolomide
Operative time > hours
Six to months post treatment
Not able to travel to UCSF for the pre- and post-study blood collection
PATIENT: Not have completed a Physician Orders for Scope of Treatment (POST) form
months post treatment
months years status post surgery, radiation and chemotherapy
Bladder Post-Void Residual Volume (PVR) of > -mL.
Prior chemotherapy treatment, including radio-sensitization in pre- and post-operative settings
Patients who are status post revascularization procedures with satisfactory cardiac function are eligible
Planned use of an epidural for surgery for post-operative pain relief
Those unwilling to participate in the follow-up call months post-surgery
The subject agrees to follow-up examinations out to months post-treatment
Post HNC primary treatment
Receiving definitive or post-operative adjuvant radiotherapy
Planned course of definitive or post-operative radiotherapy (RT) to a total dose of ? Gy using . to . Gy per fraction
Note: Post-surgical patients should proceed to registration immediately following preregistration
Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms is permitted)
FOR THE SUBJECTS ENROLLED IN YEAR : Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms is permitted)
Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms are permitted)
Received post-transplant cyclophosphamide
Anti-thymocyte globulin, alemtuzumab, bortezomib, or post-transplant cyclophosphamide as part of GVHD prophylaxis
Patients with steroid refractory cGVHD cannot have history of the following therapies at any time in the post-transplant period: B-cell depleting biologic agents within the past months, BTK/SYK/JAK/PIK inhibitors within the past weeks, CD chimeric antigen receptor (CAR) T-cell therapies at any time post-transplant
PILOTS I, II AND III: Less than months post-surgery
Willingness to return to the enrolling site for any surgical procedures including pre-operative and post-operative care
Between - years post completion of chemotherapy
Patient must be cleared for bevacizumab administration with respect to any recent surgeries, and post-surgical scans must confirm the presence of measurable residual disease
Subjects must be enrolled before starting chemoradiation, either pre -or post-surgery
Patient can be reliably reached for post-MRI follow up adverse event (AE) check
Pre-operative adult (> years of age) patients with biopsy proven (as opposed to being status post definitive surgical therapy) or highly suspected glioblastoma of the brain
Patients, whose MRI at post operative - hours are not readable due to artifacts or disease process shall not be included in the study
Radiographic diagnosis: Patients must have a brain tumor (including, but not limited to high grade gliomas, low-grade gliomas, primitive neuroectodermal tumors, ependymomas) or residual abnormality (e.g. post-operatively or post-radiation) that is measurable or evaluable on standard MRI or computed tomography (CT)
Patients will be eligible for this study regardless of prior treatment, as long as they meet other eligibility criteria; therefore, patients who are newly diagnosed, post-operative, post-radiation or post-chemotherapy are eligible
Women matched to age with our post-cancer treatment participants
The patient agrees to follow-up examinations out to -years post-treatment
No treatment affecting the status of liver between MRI/MRE and post-imaging biopsy
Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
ARM II ONLY: For patients status post radiation therapy for prostate cancer, any PSA increase from post radiation therapy nadir OR
No active bleeding in the post-operative period
Subjects must have at least tumor site that can be biopsied at acceptable clinical risk and must consent to pre- and post-treatment biopsies
Post-intervention: patient records receiving care beginning six months post training are subject to review; the first records with a diagnoses of head and neck, lung, prostate, or breast will be utilized
Males have undergone sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate, or