Karnofsky performance status > 30% (given the aggressiveness of this disease and the often severely debilitated nature of the patients at initial presentation)
Premenopausal status
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have an ECOG performance status of 0-3
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Disease status:
Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2; patients with ECOG of 3 may be allowed to enroll after discussion with the regulatory-sponsor/principal investigator and medical monitor, and if the performance status is believed to be secondary to lymphoma related symptoms and performance status is expected to improve once chemotherapy commences
PIK3CA WILD TYPE COHORT (closed 03/17/2016): ECOG performance status of 0, 1 or 2
ENDOCRINE RESISTANT AND ADJUVANT COHORT: ECOG performance status of 0, 1 or 2
ECOG performance status 0-1 (appendix I) documented within 90 days prior to randomization.
EXPANDED ACCESS COHORT: ECOG performance status =< 2
Disease status requirement:
Disease status
Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, assessed within 14 days prior to randomization. Two observers qualified to perform assessment of the performance status will be required to perform this assessment. If discrepant, the one with the most deteriorated performance status will be considered true.
Patient has experienced a decline in ECOG performance status between Baseline visit and within 72 hours prior to randomization.
ECOG >2 performance status (Appendix A)
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) is required for eligibility; those patients with lower performance status based solely on bone pain secondary to multiple myeloma are eligible
Performance Status: ECOG 0, 1, and 2 (See Appendix III)
ECOG performance status 0-1 (appendix II) assessed within 90 days of randomization.
ARM I&II: Patients must have a Karnofsky performance status >= 70% (i.e. the patient must be able to care for himself/herself with occasional help from others)
ECOG performance status ? 2. (Patients with lower performance status based solely on bone pain secondary to multiple myeloma may be eligible following consultation and approval of the medical monitor)
Disease status as defined as.
COHORT 3: ENDOMETRIAL CANCER: ECOG performance status 0 or 1
Karnofsky performance status of ? 70 (able to take care of self)
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Karnofsky performance status of ? 70 (able to care for self)
1p and 19q deletion status known
A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for patients with low performance status
Patients must have a Karnofsky performance status 60 or higher (i.e. the patient must be able to care for himself/herself with occasional help from others)
Adequate performance status (PS) as follows:\r\n* Patients >= 16 years must have Eastern Cooperative Oncology Group (ECOG) PS 0-1 and Karnofsky >= 60%\r\n* Pediatric patients < 16 years must have Lansky play-performance of 60\r\n** NOTE: Patients >= 16 years with an ECOG PS of 2 and Karnofsky >= 60 will be considered eligible at the discretion of the principal investigator if decreased ECOG performance status is felt to be related to residual neurologic deficits caused by CNS disease involvement that are not progressive or anticipated to cause clinical management problems during study participation
RAPID EXPANSION PROTOCOL (REP) ELIGIBILITY: Clinical performance status equivalent to ECOG 0-1 at the last calendar clinical visit
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Clinical performance status equivalent to ECOG 0-1 at the clinical visit prior to lymphodepletion
Must have a Functional Performance Status of less than or equal to 2 on the ECOG scale (Appendix VII).
Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (There may be certain patients with performance status [PS] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don’t want to exclude such patients who may derive benefit from this salvage regimen)
Indeterminate or negative HER2 status
Patients with performance status of =< 3 (3 only allowed if decline in status is deemed related to\r\nlymphoma and felt potentially reversible by the treating physician)
JUST PRIOR TO FIRST VACCINATION (WITHIN 21 DAYS): ECOG performance status =< 2 (Karnofsky >= 60%)
Moribund status or status epilepticus
ECOG >2 performance status (Appendix D)
Performance status < 3, unless directly related to disease process as determined by the principal investigator
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: ECOG performance 0-1
Known HER2 status
Patients must have a Karnofsky performance status of >= 60% at the time of the CD8+ memory T-cell infusion
Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2; patients with a PS of 3 are eligible if the performance status is due to their malignancy, and not a co-morbid medical condition (example [ex]: perineal pain impacting their ability to sit or ambulate, etc.)
Patients with HER2(-) status
Patients with Eastern Cooperative Oncology Group (ECOG) performance status worse than 2 (ie unable to perform their own activities of daily living [ADLs] without assistance, unable to spend less than 50% of day out of bed)
Karnofsky performance status >= 70 in the 30 day baseline period immediately prior to dosing
Performance status =< 3, unless directly related to disease process as determined by the principal investigator
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (performance status of 2 will be allowed if poor performance status is thought to be directly secondary to patient’s Hodgkin lymphoma [HL])
Karnofsky performance status (PS) scores of 70 or greater
ECOG performance =< 2 at the time of second registration
ECOG performance status of ? 2 at study entry (see Appendix A).
Other Requirements\r\n* Patients must be able to give informed consent\r\n* Patients must have ECOG performance status 0, 1 or 2 and/or Karnofsky performance status (KPS) > 50\r\n* Patients must be able to swallow\r\n* Patients must be able to sit up with or without assistance\r\n* Patients must be able to undergo contrast-enhanced MRI (Cohort D)
Subject has a Karnofsky performance status ?60% (>50% if due to bony involvement of myeloma (see Appendix IV).
Adequate performance status (ECOG 0 or 1). (Appendix 1)
HER2 status negative
ECOG performance status 0-2 (Appendix 3)
Patients should have a performance status (Karnofsky score) of > 80 out of 100, i.e. can carry on normal activity with effort while showing some signs or symptoms of disease
Adequate performance status (ECOG 0 or 1) (Appendix 1)
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
ECOG performance status of 0 - 1 (Appendix C).
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)\r\n* Exception will be made for patients with ECOG performance status =< 3 and Karnofsky performance scale >= 50%, who require the use of wheelchairs, walkers or canes as well as assistance with daily routines secondary to disabilities caused by ECD cerebellar or brain disease that has been stable for >= 3 months
Recursive partitioning analysis (RPA) class I-II/Karnofsky performance status >= 70%
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) unless due to neurologic deficits caused by CNS lymphoma with the following exceptions: patients with ECOG performance status (PS) = 4 where neurologic deficits are unlikely to resolve with tumor resolution and may cause clinical management problems are excluded
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Patients must have results from the determination of BAF250a immunohistochemistry (IHC) status and must have a BAF250a expression status that is currently open to enrollment
Clinical performance status equivalent to ECOG 0-1 at the clinical visit prior to apheresis
Karnofsky functional status rating >= 70
Lansky performance status ? 50% (children) or Karnofsky performance status ? 70% (adults) or ECOG performance status 0-2 (adults)
Patient has an ECOG performance status ? 2 (Patients with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible)
Performance status with Eastern Cooperative Oncology Group (ECOG) score =< 2; patients with performance status of 3 may be considered as long as the decline has been of short duration (< 1 month), and is due to their malignancy and not a comorbid condition (example: pain limiting activity)
RB status
ECOG performance status >2 after optimization of analgesics
ECOG performance status of 0 or 1 (see Error! Reference source not found.).
Premenopausal status
Premenopausal status
Performance status < 3 (unless previous performance status was 0 or 1 and deterioration is due to lymphoma which treating medical doctor [MD] expects to reverse with therapy)
Have a Karnofsky performance status >= 70 (i.e. the patient must be able to care for himself/herself with occasional help from others)
ECOG performance status =< 2, unless the decline of the performance status is considered to be related to CLL symptoms
Participants must have a performance status of 0-2 based on Eastern Cooperative Oncology Group (ECOG) criteria; participants with a poor performance status (3-4) based solely on bone pain will be eligible, provided there is documentation to verify this
Eastern Cooperative Oncology Group (ECOG) performance status =< 2; patients with ECOG performance status of 3 (defined as being capable of only limited self-care, confined to bed or chair more than 50% of waking hours) will also be eligible only if the lower performance status is judged to be directly related to steroid and/or cGVHD effects
Pre-study ECOG performance status 0-2. Patients with lower performance status based solely on bone pain will be eligible.
Performance status must be Cancer and Leukemia Group B (CALGB) performance status (PS) 0, 1, or 2 (or Karnofsky 40-100%)
ECOG performance status of 0 or 1, measured at screening and immediately before the start of treatment.
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
ECOG performance status of 0 or 1 (see Appendix 8)
ECOG Performance status 0-1 (Appendix B)
Karnofsky performance status >= 70 (Radiation Therapy Oncology Group [RTOG] recursive partitioning analysis [RPA] class I & II)
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
ECOG PS (Eastern Cooperative Group Performance Status) of 0 or 1. 8. Ability to swallow oral capsules without difficulty. 9. Pregnancy Prevention Risk Management Plan:
Have an ECOG Performance Status of ? 1. Refer to Appendix 1.
Performance status of 0-2 based on the Eastern Cooperative Oncology Group (ECOG) criteria; patients with performance status 3 or 4, based solely on bone pain, are also eligible, provided that there is a source document to verify this
Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1. NOTE: Subjects with a performance status of 2 can be enrolled if the subject's confinement to bed and inability to carry out work activities is due solely to cancer-related pain, as assessed by the Investigator.
ECOG performance status of 0 or 1 (see Appendix C)
Low Performance Status (ECOG > 2; Appendix E).
ECOG performance status ? 1 (Karnofsky ? 70%; see Appendix B).
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
Performance score of >=50% according to the Karnofsky/Lansky performance status scale (subjects with a performance status of <=50% can be enrolled if the subject's confinement to bed and inability to carry out activities is due solely to cancer-related pain, as assessed by the investigator).
Recursive partitioning analysis (RPA) class I (Karnofsky performance status [KPS] >= 70%, primary cancer controlled, age < 65, metastases in brain only) or class II
Performance status of Eastern Cooperative Oncology Group (ECOG) =< 2 or Karnofsky >= 60%; note: participants with lower performance status based solely on bone pain secondary to multiple myeloma will be eligible
Patients with performance status of =< 3 (Eastern Cooperative Oncology Group performance status scale, 3 only allowed if decline in status is deemed related to lymphoma and felt potentially reversible by the treating physician)
There are no restrictions related to performance status or life expectancy
Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs
Karnofsky performance status >= 60 per COH SOP
Patients must have a Karnofsky performance status (KPS) >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
There are no restrictions related to performance status or life expectancy
Patients must have a Karnofsky performance status >= 60 % (i.e. the patient must be able to care for himself/herself with occasional help from others)
There are no restrictions related to performance status and life expectancy
Incarceration/ward of the state status
Poor preoperative performance status as defined by: timed get up and go (< 15 seconds)
PATIENT: Eastern Cooperative Oncology Group (ECOG) performance status of > 2 or Karnofsky performance status < 60 (suggesting patient is capable of only limited self-care, confined to bed or chair more than 50% of waking hours, or requires considerable assistance and frequent medical care) as rated by the attending oncologist
Karnofsky performance status >= 70 (Radiation Therapy Oncology Group [RTOG] recursive partitioning analysis [RPA] class I & II)
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2. However, potential subjects with an ECOG of 3 may be enrolled provided their condition does not preclude performing the actions required by study participation (e.g., opening medication bottles, swishing the oral rinse and spitting out, completing or participating in completion of daily diaries and FACT-H&N forms).
CONTROL (HEALTHY) GROUP: ECOG performance status 0-1
Karnofsky performance status: Full intensity conditioning, 80-100%; reduced intensity conditioning, 60-100%
Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
General performance status evaluated by ECOG 0-2 scale.
ECOG performance status of 0 to 2 (Appendix C)
Karnofsky performance status >= 70 with the ability to walk unassisted
The patient must have recovered from surgery with the incision completely healed and no signs of infection; if adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved; the patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky performance status [KPS] > 70%)