Prior exposure to CTLA- inhibitors (ipilimumab and tremelimumab) is not permitted; prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and granulocyte-macrophage colony-stimulating factor (GM-CSF)
Treatment within days prior to Cycle Day with: i) long acting erythropoiesis stimulating agents, ii) long acting Granulocyte colony-stimulating factor (G-CSF), iii) granulocyte- macrophage colony stimulating factor (GM-CSF), iv) -aza, lenalidomide or decitabine, or v) iron chelation and within days prior to Cycle Day with short acting erythropoiesis stimulating agents and short acting G-CSF.
Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the weeks prior to study drug administration (Cycle Day )
Concurrent MDS therapies, including lenalidomide, erythropoietin, cyclosporine/tacrolimus, granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. (Prior treatment with these agents is permitted, provided that completion is at least week before the first dose of study treatment.)
Use of hematopoietic colony-stimulating growth factors (e.g. granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF], macrophage colony-stimulating factor [M-CSF]) =< weeks prior start of study drug; an erythroid stimulating agent is allowed as long as it was initiated at least weeks prior to the first dose of study treatment
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least week and of pegylated G-CSF for at least weeks
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within weeks prior to study start
Subjects who have used any of the following within weeks prior to registration: blood or platelet transfusions, erythropoietin, and biologic response modifiers such as granulocyte macrophage colony-stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF)
Concurrent use of granulocyte macrophage colony-stimulating factor (GM-CSF).
Concurrent use of human granulocyte-macrophage colony-stimulating factor
Patients receiving the following medications at study entry or within the preceding weeks are excluded:\r\n* Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids.\r\n* Allergy desensitization injections.\r\n* Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex).\r\n* Any growth factors (e.g. granulocyte-macrophage colony-stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF), erythropoietin).\r\n* Interferon therapy.\r\n* Interleukin- or other interleukins.\r\n* For immune modulating agents, it may be necessary for more than weeks to have elapsed since completion of that therapy.
=< days before first dose of protocol-indicated treatment:\r\n* Receipt of granulocyte colony?stimulating factor (G-CSF) or granulocyte?macrophage colony stimulating factor (GM-CSF).
Significant allergic reaction to contrast dye or granulocyte-macrophage colony-stimulating (GM-CSF)
Patients must not be receiving growth factors (granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]), except for erythropoietin
Patients must not have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support weeks prior to first BA administration.
Known hypersensitivity reaction to the granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF
Known allergy or hypersensitivity to KLH, granulocyte macrophage colony stimulating factor (GM-CSF) or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
Has received granulocyte-macrophage colony-stimulating factor (GM-CSF) within days of first dose of pembrolizumab
Current use of granulocyte colony-stimulating factory (G-CSF) or GM-CSF.
Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF) use within weeks of study treatment and throughout the study
Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within weeks prior to study treatment
Has received the following at study entry or within weeks prior to study day or has not recovered (i.e., =< grade or at baseline) from adverse events due to agents administered more than weeks earlier:\r\n* Prior anti-cancer monoclonal antibody (mAb), including anti-PD-, anti-PD-L and anti-PD-L blockade\r\n* Any growth factors (e.g. granulocyte-macrophage colony-stimulating factor [GM-CSF], granulocyte-colony stimulating factor [G-CSF], erythropoietin)\r\n* Interferon or interleukin therapy\r\n* Other agents with putative immunomodulating activity
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within days of study drug administration; use of such agents while on study is also prohibited
No transfusion of blood or blood products within weeks and no granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within weeks
DONOR: Donor unfit to receive granulocyte-macrophage colony-stimulating (G-CSF) and undergo apheresis
Absolute neutrophil count < cells/mm^; no granulocyte colony stimulating factors (G-CSF or GM-CSF) allowed within week of enrollment; no pegylated granulocyte colony stimulating factors are allowed within weeks of treatment start
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within days of study drug administration; use of such agents while on study is also prohibited
Subject has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within weeks prior to study day
Known hypersensitivity to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH), or granulocyte colony-macrophage stimulating factor (GM-CSF)
Treated with any hematopoietic colony-stimulating growth factors (e.g., granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]) =< weeks prior to study registration; NOTE: erythropoietin or darbepoetin therapy, if initiated at least weeks prior to study registration, may be continued
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]) =< weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least weeks prior to enrollment, may be continued
Patients with known hypersensitivity to granulocyte-macrophage colony-stimulating factor (GM-CSF), yeast-derived products, or any component of Leukine
Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (e.g., granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within days of study drug administration; use of such agents while on study is also prohibited
Screening ANC should be independent of granulocyte and granulocyte/macrophage colony stimulating factor (filgrastim [G CSF] and sargramostim [GM CSF]) support for at least week and of pegylated G CSF for at least weeks
Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor, and recombinant erythropoietin) within weeks before the first dose of study treatment.
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin) within weeks prior to study Day ;
Any contraindication to receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) based vaccine products
Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within days prior to administration of the first study vaccination;
Cancer therapies, including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) within weeks prior.
Hematopoietic growth factors: erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists at least days ( days for Aranesp), prior to study enrollment.
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support weeks prior to first IMP administration.
Any hematopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within days prior to receiving study treatment
Any hematopoietic growth factors (eg, filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostin [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within days of the first dose of study drug or pegylated G-CSF (pegfilgrastim) or darbepoetin within days of the first dose of study drug.
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.
Any hematopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; GCSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within days prior to receiving study treatment
Subjects who have received systemic cancer therapy, radiotherapy, investigational drug treatment outside of this study within weeks before the start of study treatment, granulocyte colony stimulating factors, (G-CSF) or granulocyte macrophage-stimulating factors (GM-CSF), erythropoietin-stimulating agents within weeks before the start of general screening, drugs with known renal toxicity and strong cytochrome P A (CYPA) inhibitors or strong CYPA inducers within weeks before the treatment.
Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeast
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), erythropoietin, within days of study drug administration; use of such agents while on study is also prohibited
Use of biologic response modifiers, such as granulocyte macrophage colony-stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF) within weeks prior to screening
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within weeks of study drug administration; use of such agents while on study is also prohibited; prior use of growth factors should be documented in the patients medical history
Patients with any contraindication to receiving rhu granulocyte macrophage colony stimulating factor (rhuGM-CSF) based products
Patients who have been treated with any hematopoietic colony-stimulating growth factors (eg, granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]) =< weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least weeks prior to enrollment, may be continued
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.
Allergy to both penicillin & sulfa or suspected hypersensitivity to granulocyte-macrophage colony stimulating factor (GM-CSF), dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least week and of pegylated G-CSF for at least weeks
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least week and of pegylated G-CSF for at least weeks
Condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. Patients who received colony stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within weeks prior to the first dose of study treatment are not eligible
Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, recombinant erythropoietin) within days prior to the first dose of GSK.
Subjects must have fully recovered from the toxic effects of any prior therapy; at least weeks should have elapsed since the last dose of chemotherapy ( weeks in the case of nitrosourea containing therapy); subjects must have recovered from previous colony-stimulating factor therapy and have been off colony-stimulating factors (G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF], interleukin [IL]-) for more than days and off erythropoietin for days
Patients with any contraindication or known hypersensitivity to receiving sargramostatin (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor [GM-CSF]); Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
No concurrent use of erythroid stimulating agents, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) is allowed during study except in cases of febrile neutropenia where G-CSF can be used for short term; growth factors must be stopped days prior to study
Any hematopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within days prior to receiving study treatment
Treatment with granulocytemacrophage colony stimulating factor (GM-CSF) or granulocyte (G-CSF) within weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and - treatment week imaging sessions