Any medical condition for which prednisone (corticosteroid) is contraindicated
Systemic corticosteroid use within 7 days before planned start of study therapy
Patients have had no previous treatment except corticosteroid use
Off or low dose (=< 4 mg/day by Decadron) corticosteroid for at least for 2 weeks before the first pre-surgical vaccine
Ongoing corticosteroid use.
?28 days for prior systemic corticosteroid therapy.
?7 days for immune-suppressive-based treatment for any reason. Note: Use of inhaled or topical corticosteroid use for radiographic procedures is permitted. Note: The use of physiologic corticosteroid replacement therapy may be approved after consultation with the sponsor.
Untreated or symptomatic brain metastases requiring corticosteroid therapy (no corticosteroid use for this purpose in the preceding 4 weeks)
Use of systemic corticosteroid therapy within 2 weeks of study enrollment, including patients receiving replacement corticosteroid therapy; note: only topical, inhaled and intranasal steroid therapy is permitted
Corticosteroid therapy for 7 days prior to enrollment
Any patient receiving chronic corticosteroid administration prior to study enrollment is ineligible
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated.
Patients requiring corticosteroid therapy at a dose of 15 mg or more per day of prednisone or the equivalent; pulsed corticosteroid dose for disease control is acceptable
Patients must require no corticosteroid therapy or dose of less than 15 mg per day of prednisone or the equivalent; pulsed corticosteroid dose for disease control is acceptable until the day before the start of lymphodepletion
Patients who require or are likely to require corticosteroid or other immunosuppressive drugs for intercurrent disease (any other significant medical problem related to or independent from the neuroblastoma or its treatment) while tentatively scheduled to receive treatment on this study are ineligible; the only exception is for patients known to require 2 mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product transfusion in order to avoid allergic transfusion reactions
FOR ALL PHASES (Ib AND II): Systemic continuous corticosteroid therapy at a daily dose higher than 15 mg prednisone or equivalent is not allowed; patients may be using topical or inhaled corticosteroids; previous corticosteroid therapy must be stopped or reduced to the allowed dose at least 7 days prior to the first study drug administration; if a patient is on chronic corticosteroid therapy, corticosteroids should be de-escalated to the maximum allowed dose after the patient has signed the consent document
Systemic corticosteroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowed
Corticosteroid use =< 2 weeks prior to registration; NOTE: patients must be off corticosteroids for at least 2 weeks prior to registration; this includes oral, IV, subcutaneous, or inhaled route of administration; patients on chronic corticosteroid for adrenal insufficiency or other reasons may enroll if they receive less than 10 mg/day of prednisone (or equivalent)
Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/ prednisolone once daily
Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
EXCLUSION CRITERIA FOR TNBC: Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
Systemic corticosteroid steroid therapy of any dose is not allowed within 14 days prior to the required leukapheresis, or the initiation of the conditioning chemotherapy regimen; corticosteroid creams, ointments, and eye drops are allowed
Corticosteroid use > 4 mg/day at time of consent
Immunosuppressive corticosteroid doses (>10mg prednisone) within 28 days prior to treatment with REGN2810
Corticosteroid use within 2 weeks of study treatment
TREATMENT: Patients receiving systemic corticosteroid within 48 hours of CTL infusion
Patients requiring ongoing daily corticosteroid therapy at a dose of > 15 mg of prednisone per day (or equivalent); pulsed corticosteroid use for disease control is acceptable
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid
Patients currently receiving chronic corticosteroid treatment (longer than 8 weeks duration) for management of pre-existing adverse events, or patients with a history of chronic corticosteroid treatment longer than 8 weeks' duration for AEs within 6 months of Screening are excluded
Chronic systemic corticosteroid use (ie, prednisone > 10 mg QD or the equivalent of longer duration than 8 weeks for any medical condition) or history of chronic corticosteroid use (longer than 8 weeks duration) within the past 6 months; treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ? 10 mg QD or the equivalent, and patients must have no history of adrenal crisis. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable
Chronic use of high-dose oral corticosteroid therapy .
Chronic adrenal failure or is receiving concurrent long-term corticosteroid therapy.
Prior cytotoxic therapies are NOT allowed; the only exception is prior corticosteroid therapy (prednisone up to 1 mg/kg for =< 3 months) which must be stopped at least 1 week prior to study enrollment
Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization, except prophylactic use of steroids prior to paclitaxel administration
Patient is on any systemic corticosteroid therapy within one week before the planned date for first dose of treatment or on any other form of immuno-suppressive medication
Treatment with systemic corticosteroid or immune-modulators =< 30 days prior to randomization
Chronic systemic or regular inhaled corticosteroid use within 7 days prior to initiation of protocol therapy
Systemic anti-myeloma therapy including systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to the required leukapheresis
Systemic corticosteroid steroid therapy of greater than 5 mg/day of prednisone or equivalent dose of another corticosteroid are not allowed within 2 weeks prior to either the required leukapheresis or the initiation of the conditioning chemotherapy regimen
Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy
Current need for chronic corticosteroid therapy or other immunosuppressive agents (>= 10 mg of prednisone daily or an equivalent dose of other corticosteroid), or patients who have received systemic corticosteroids =< 2 weeks prior to starting study drug
Completed treatment with systemic corticosteroid or immune-modulators < 30 days prior to registration;
Use of systemic corticosteroid.
Subjects on immunosuppressive medications such as azathioprine, mycophenolate mofetil, cyclosporine or require chronic corticosteroid use (defined as ? 3 months of prednisone dose equivalent of ? 10 mg).
No oral or intravenous corticosteroid use within 2 weeks prior to study entry
Pre-existing condition that warrants long-term corticosteroid use; physiologic replacement is not permitted
Systemic corticosteroid (inhalers are allowed) within 7 days before the first dose of study drug.
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid.
Medical condition that would make prednisone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone bid
Have a pre-existing condition that warrants long-term corticosteroid use; inhaled steroids are allowed
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Stable dose of non-corticosteroid immunosuppressants for the 2 weeks prior to first dose of AMG 592.
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Any chronic medical condition requiring a higher dose of corticosteroid than 5 mg prednisone/prednisolone bid
Have received systemic corticosteroid (inhalers are allowed) within 7 days before the first administration of study drug
Current need for chronic corticosteroid therapy (>= 10 mg of prednisone daily or an equivalent dose of other corticosteroid), or patients who have received systemic corticosteroids =< 2 weeks prior to starting study drug
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Have a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Systemic corticosteroid therapy (ongoing)
No increase in corticosteroid dose in the week prior to baseline brain imaging
Known treatment with systemic corticosteroid within one week prior to the first administration of study drug
Patients on immunosuppressive drugs (with exception of corticosteroid)
No previous radiotherapy or chemotherapy other than corticosteroid therapy
Corticosteroid monotherapy for lymphoma within 1 week of the first dose of study drug
Chronic or high-dose corticosteroid therapy
Patients who are on (or will require) prolonged systemic corticosteroid treatment during the study, except for:
History of chronic corticosteroid use
Continuous corticosteroid therapy within 21 days prior to first dose of orteronel
Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
Patients with a pre-existing condition that warrants long-term corticosteroid use in excess of study dose
Systemic corticosteroid therapy <7 days prior to first dose of the study medication
Have received a systemic corticosteroid within one week prior to the first administration of study drug;
Need for current chronic corticosteroid therapy
Patients on immunosuppressive drugs (with exception of corticosteroid)
Stable dose of corticosteroid >= 14 days prior to registration
Chronic systemic corticosteroid use (>14 days) at the time of study enrollment.
Any expected corticosteroid use during study enrollment at higher doses than will be used in this study.
Concurrent systemic corticosteroid therapy;
Subjects who have concurrent illness requiring systemic corticosteroid use other than the planned dexamethasone during conditioning therapy
Corticosteroid use > 10 mg prednisone/day
Chronic systemic corticosteroid use (> 14 days) at the time of study enrollment
Corticosteroid within the past 30 days prior to registration on this study for greater than one week duration
Patient must be willing to remain on corticosteroid therapy for 4 days postoperatively
Patient who has been started on systemic corticosteroid therapy within 72 h prior to study drug administration or is planned to receive a corticosteroid as part of the chemotherapy regimen
Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen
Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
Systemic corticosteroid therapy within 7 days before enrollment.