Subjects who are at significant risk for general anesthesia
Major surgery requiring general anesthesia within 14 days before the first dose of any study drug or a scheduled surgery during study period; (placement of a central line or port-a-catheter is acceptable within this time frame and does not exclude the patient)
Must be capable of treatment without general anesthesia
Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
Stable from a cardiopulmonary standpoint to continue with prolonged surgery and anesthesia
Patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia but excluding a procedure for insertion of central venous access)
Unacceptable anesthesia risk
History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
Has not fully recovered from any effects of major surgery, and is free of significant detectable infection. Surgeries that required general anesthesia must be completed >2 weeks before first study drug administration. Surgery requiring regional/epidural anesthesia must be completed >72 hours before first study drug administration and participants should be recovered.
Major surgery (eg, requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (ie, unhealed wound); Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate
Patients must be a surgical candidate (e.g. their disease must be considered resectable before any treatment and must have no serious medical contraindications that definitively preclude undergoing general anesthesia)
Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration; surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration
Major surgery (requiring general anesthesia) within 30 days prior to initiation of therapy
Unable to undergo general, spinal or local anesthesia
Major surgery (requiring general anesthesia) within 3 months prior to dosing.
If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
Medical conditions that preclude the use of general anesthesia;
Had hospitalization for infection or major surgery (e.g., requiring general anesthesia) within 2 weeks before enrollment or have not fully recovered from surgery; Note: subjects with surgical procedures conducted under local anesthesia may participate
Patients will be evaluated by the anesthesia team prior to surgery.
Adult patients who require monitored anesthesia for PET scanning due to claustrophobia
Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration; surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration
If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
Monitored anesthesia care (i.e., regional anesthesia alone without plans for general anesthesia)
Unable to tolerate general anesthesia
Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.
Major surgery (requiring general anesthesia) within 2 weeks prior to initiation of therapy
Spinal anesthesia
Pregnant or lactating subjects. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability.
Within 28 days before first dose of avelumab: anti-cancer treatment, major surgery requiring general anesthesia, or the use of any investigational agent
Patients with contraindications to general anesthesia, as determined by the treating physician or surgeon
Contraindications to general anesthesia
Subject is a surgical candidate, i.e., is able to undergo general anesthesia and surgical resection for diagnosis of cancer
DONOR: Factors that place the donor at increased risk of general anesthesia and bone marrow harvest, such as congenital or acquired bleeding disorders, intolerance or allergy to anesthesia, prior serious surgical complications, or uncontrolled cardiac or pulmonary disorders
Patient must be cleared for surgery and low/moderate risk for perioperative complications related to general anesthesia
Contraindication to general anesthesia
Systemic diseases associated with unacceptable anesthesia or operative risk
Patients must be stable from cardiopulmonary and hemodynamic standpoints to continue with prolonged surgery and anesthesia
HAPLOIDENTICAL RELATED DONOR: Haploidentical donors will undergo marrow harvest with general anesthesia; subjects will undergo anesthesia consultation prior to enrollment; cluster of differentiation (CD)34+ fraction will be determined
Unacceptable anesthesia risk
The presence of medical conditions contraindicating general anesthesia or transoral surgical approaches; this is not an exclusion criterion for the non-surgical arm
History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia.
MATCHED RELATED DONOR: Matched related donors that will undergo marrow harvest with general anesthesia; subjects will undergo anesthesia consultation, and meet criteria for eligibility/enrollment; CD34+ fraction will be determined
HAPLOIDENTICAL RELATED DONOR: Haploidentical donors that will undergo marrow harvest with general anesthesia; subjects will undergo anesthesia consultation, and meet criteria for eligibility/enrollment; cluster of differentiation 34 positive (CD34+) fraction will be determined
Subjects at significant risk for general anesthesia
Major surgery (requiring general anesthesia) within 3 months prior to dosing.
Major surgery (eg., requiring general anesthesia) within 3 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study
Subjects must have completed chemotherapy, targeted therapy, investigational therapy, other immunotherapy, prior radiotherapy, or major surgery (requiring general anesthesia) at least 28 days before administration of the first dose of study drug(s). Subjects undergoing minor surgical procedures and biopsies that do not require general anesthesia may begin receiving study therapy if sufficiently recovered as determined by the treating investigator. Clinically significant toxicity experienced during any prior therapy must be resolved or stabilized before the first dose of study drug(s).
Major surgery (requiring general anesthesia) within 14 days before the first dose of study\r\ndrug or a scheduled surgery during study period
Subjects at significant risk with general anesthesia
Unfit for minimal sedation anesthesia
Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration; surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration and subjects should be recovered
Prior surgery that required general anesthesia must be completed at least 2 weeks before study drug administration\r\n* Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration and subjects should be recovered
Active, uncontrolled impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic or hematopoietic systems which, in the opinion of the Investigator, would predispose the subject to the development of complications from the administration of intravesical therapy and/or general anesthesia.
Eligible for general anesthesia (ASA category ? 3)
Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration; surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration and subjects should be recovered
Unable to tolerate general anesthesia and prone position
Had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy.
Any surgery, where general anesthesia was administered, must have occurred at least 7 days prior to study enrollment
Patient eligible for epidural anesthesia, and general anesthesia (in case of complication, requiring intervention).
Any spinal pathology which can prevent safe administration of epidural anesthesia
Pre-anesthetic medical evaluation and clearance for anesthesia
Systemic diseases associated with unacceptable anesthesia or operative risk
Major surgery (includes surgery that carries significant risk of blood loss, extended periods of general anesthesia, or requires at least an overnight hospital admission) within 28 days before starting treatment
Patients must have a Karnofsky performance status (KPS) >= 80% and be considered candidates for general anesthesia, hepatic resection and hepatic artery pump placement
Patients requiring general anesthesia for fiducial placement
GENERAL MEDICAL EXCLUSIONS:
Major surgery (e.g., requiring general anesthesia) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound), or surgery planned during the time the patient is expected to participate in the study. Note: patients with planned surgical procedures to be conducted under local anesthesia may participate.
Contraindications to general anesthesia
Has had major surgery requiring general anesthesia and/or mechanical ventilation within the 28 days prior to randomization
Has had within the 4 weeks prior to initiation of study drug, or is expected to have during the study period, surgery requiring general anesthesia.
Patients must have adequate cardiac and pulmonary function and otherwise be expected to tolerate general anesthesia
Patients at significant increased risk for general anesthesia are not eligible
Has had surgery requiring general anesthesia within 4 weeks of starting the study.
Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration.
Patient is cleared to undergo paralytic anesthesia
General and Demographics
Any major surgery (e.g. requiring general anesthesia).
Has had surgery requiring general anesthesia within 4 weeks of starting the study
Does the subject have a coagulation profile that would allow for the safe performance of surgery under general anesthesia?
GENERAL CRITERIA
Contraindications to general anesthesia
Have had a surgical procedure requiring general anesthesia or inpatient hospitalization for recovery less than 4 weeks prior to beginning protocol therapy.
Contraindications to general anesthesia
Karnofsky performance status (KPS) >= 60% and be considered candidates for general anesthesia, abdominal exploration and hepatic artery pump placement
History or evidence of clinically significant pulmonary disease that precludes the use of general anesthesia
Patients who have been hospitalized for infection or major surgery (e.g., requiring general anesthesia) within 2 weeks before registration or have not fully recovered from surgery are not eligible; Note: Subjects with surgical procedures conducted under local anesthesia may participate
Have anesthesia surgical assignment category IV or greater,
Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia
Is known or suspected to have an allergy to opioids, muscle relaxants or other medications used during general anesthesia
Scheduled for an elective surgery requiring general anesthesia
GENERAL MEDICAL EXCLUSIONS
Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for TIVA (total intravenous anesthesia)
Willing to not undergo any elective surgical procedure with general anesthesia or conscious sedation through the 1 month post-vaccination visit
Willing to not undergo any other elective surgery procedure with general anesthesia or conscious sedation during the treatment period
Participants must have no medical contraindications for flexible laryngoscopy using topical anesthesia, and in the setting of a contraindication to topical anesthesia, general anesthesia may not be used as a substitute
General anesthesia, if indicated, is acceptable in patients whose lesions would require general anesthesia for laryngoscopy and biopsy according to routine standard of care
Patient should be eligible for both spinal/epidural anesthesia (planned procedure), and general anesthesia (in case of complication, requiring intervention).
Patients should be capable of achieving imaging without the need for sedation or anesthesia
Patients with a contraindication to sedation or general anesthesia
Patients with a contraindication to sedation or general anesthesia
Pulmonary disease precluding monitored anesthesia care or general anesthesia
Need for sedation or anesthesia
Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively
Patient would require anesthesia for the study
Adult patients who require monitored anesthesia for PET scanning
Patients with contraindication/s for general anesthesia (e.g., severe and active coronary artery disease, chronic obstructive pulmonary disease [COPD] with forced expiratory volume in 1 second [FEV1] < 1 liter, uncontrolled hypertension, increased intracranial pressure, history of intolerance to general anesthesia)
Contraindication to general anesthesia
Requiring intubation for anesthesia
Patients who are unable to tolerate general anesthesia
Patients who are felt to be a “difficult airway” for induction of general endotracheal anesthesia
Patients requiring anesthesia
Adult patients who require monitored anesthesia for PET scanning
Adult patients who require monitored anesthesia for MRI scanning
Able to undergo MRI without general anesthesia
Patients needing general anesthesia for MRI
GENERAL POPULATION:
Patients who require general anesthesia for MIBG imaging studies
Adult patients who require monitored anesthesia for PET scanning or MRI imaging
Adult patients who require monitored anesthesia for PET scanning
Patients who require sedation with general anesthesia for imaging studies are not eligible for the study
Adult patients who require monitored anesthesia for PET scanning
Adult patients who require monitored anesthesia for MRI scanning
Requirement for sedation or anesthesia of any kind in order to undergo MRI scanning
Adult patients who require monitored anesthesia for PET scanning
Patient would require anesthesia for the study
Subjects who require monitored anesthesia for MRI scanning
Adult patients who require monitored anesthesia for PET scanning
General anesthesia within one year