Patients must have had cystoscopy confirming no visible papillary tumor within 21 days prior to registration; (CIS disease is not expected to have been completely excised)
No congenital or acquired immune deficiency. These patients are excluded due to the expected intense immunosuppression, increased risk of opportunistic infections, and higher expected septic death rate in this subgroup of patients with this proposed therapy.
Subject must be stable enough to be expected to complete dosing through the DLT observation period as assessed by the investigator.
Must have medical assessment consistent with prognosis for an expected survival of at least 6 months and be clinically appropriate to receive a 12 week hiatus from any cytotoxic treatment according to the best clinical judgement of the treating investigator.
No known Food and Drug Administration (FDA) -approved therapy available that is expected to prolong survival by greater than 3 months
Definitive cancer surgery is expected to be performed < 10 days or more than 12 weeks post study enrollment as determined by the enrolling physician
Moribund patients not expected to survive up to 48 hours
Any other ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the exclusion criteria and which is expected to significantly increase the risk of transplantation
Patients must have a minimum expected duration of survival of 8 weeks as determined and documented by the attending surgeon or medical oncologist
Patients with severe comorbidities, not related to their EBV-associated malignancy, that would be expected to preclude their survival for the 6 weeks required to assess response of T cell therapy
Is not expected to be available to receive study drug within 16 weeks from the time of baseline biopsy for any reason
Patients not expected to be available for follow-up for at least 114 days after transplant
Patients who have received at least 1 transfusion per year in the last 2 years and who are expected to have a continuing requirement (based on Investigator's judgement) during the duration of the trial
Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
Concurrent active malignancy with expected survival of less than 1 year. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML. All subjects with concurrent malignancies will be reviewed by the principal investigator (PI) prior to enrollment.
Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist
Expected communication between ventricles and resection cavity as a result of surgery
Expected need for regular immunosuppressive therapy
Expected to have surgery during study period;
Subjects must be stable and, in the opinion of the investigator, be expected to complete 4 week treatment period.
Patients with a significant intercurrent illness (any ongoing serious medical problem unrelated to cancer or its treatment) that is not covered by the detailed exclusion criteria and that is expected to interfere with the action of study agents or to significantly increase the severity of the toxicities experienced from study treatment are not eligible
Has had prior radiation for other diagnoses to the expected treatment field
B-cell hematologic malignancies expected to express the cluster of differentiation 20 (CD20) antigen who have relapsed after or failed to respond to at least one prior treatment regimen and for whom there is no available therapy expected to improve survival
Other serious non-malignancy-associated medical conditions that may be expected to limit life expectancy or significantly increase the risk of Serious Adverse Events (SAEs).
Expected non-compliance.
Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist
Expected non-compliance.
Patients expected to get surgery.
Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
Patients expected to survive longer than 3 months from the start date of the protocol treatment
Subject is not expected to show a therapeutic response to existing available treatment.
Patients with acute medical condition (e.g. pneumonia, sepsis) that is expected to hinder them from completing this study
Any serious co-morbidity which is expected to affect survival more adversely than GBM
Patients must have an expected minimum life span of 60 days
All patients are expected to be followed for at least 1 year after the initiation of therapy
No known Food and Drug Administration (FDA)-approved therapy available that’s expected to prolong survival by greater than 3 months
Expected non-compliance.
Expected non-compliance.
Expected to receive ondansetron as part of antiemetic regimen (Cycle 1); Expected to receive a 5-HT3 antagonist as part of antiemetic regimen (Cycles 2-6)
Expected non-compliance.
Only patients who are expected to survive at least 6 weeks will be eligible for this study
Failed previous antifungal therapy or expected to live < 3 days.
Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
Expected to undergo therapeutic thoracentesis in the next 2 weeks.
Acute thrombocytopenia in patients with hematological malignancies who are in remission and are receiving myelosuppressive consolidation chemotherapy that is expected to induce marrow aplasia for at least 2 weeks or;
Expected primary wound closure performed at the time at surgery
The expected hospitalization is at least 3 days to receive moderate to high intensity chemotherapy
Expected to use other 5HT3 antagonists or NK1 antagonists during the study
Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
Expected to continue cancer care at University of Wisconsin Carbone Cancer Center (UWCCC) for the duration of the study
Attending physician assessment of prognosis with expected life expectancy of > 2 months
Treatment expected to last no longer than 12 months (patient)
Expected duration of ADT at least 12 months from date of study consent
A CXR shows ?20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
Patients who are not expected to be available for follow-up in our institution for at least 180 days after the transplant
Expected to receive at least 2 additional cycles (at least 6 total weeks) of first line myelosuppressive cyclic chemotherapy after randomization. Subjects should not be expected to receive only maintenance chemotherapy.
An expected hospital stay of 3-4 weeks or longer
Study participants are expected to be generally healthy and non-symptomatic for cervical disease
Is not expected to receive a minimum of 10 days of POS IV solution
Patients who are not expected to receive cancer therapy before imaging sessions are completed.
Expected lifespan less than 12 months by investigator assessment
Expected lifespan of 12 weeks or less
Patient is expected to see their physician or another member of their care team at least 3 times annually
Patients with life expectancy of at least 12 months and who are expected to be able to complete the full follow-up assessment in the protocol.