title: Phase I trial of p28 (NSC745104), a non-HDM2-mediated peptide inhibitor of p53 ubiquitination in pediatric patients with recurrent or progressive central nervous system tumors: A Pediatric Brain Tumor Consortium Study.
abstract: p53 is a promising target in human cancer. p28 is a cell-penetrating peptide that preferentially enters cancer cells and binds to both wild-type and mutant p53 protein, inhibiting COP1-mediated ubiquitination and proteasomal degradation. This results in increased levels of p53, which induces cell cycle arrest at G2/M. We conducted a phase I study to determine the maximum-tolerated dose (MTD) and describe the dose-limiting toxicities (DLTs) and pharmacokinetics (PKs) of p28 in children.
  
  
  
  Children aged 3-21 years with recurrent or progressive central nervous system tumors were eligible. Intravenous p28 was administered 3 times weekly for 4 consecutive weeks of a 6-week cycle at 4.16 mg/kg/dose (the adult recommended phase II dose) using a rolling-6 study design. Expression status of p53 was characterized by immunohistochemistry, and serum PK parameters were established on the second dose.
  
  
  
  Of the 18 eligible patients enrolled in the study, 12 completed the DLT monitoring period and were evaluable for toxicity. p28 was well-tolerated; 7 participants received ≥2 courses, and the most common adverse event attributed to the drug was transient grade 1 infusion-related reaction. PK analysis revealed a profile similar to adults; however, an increased area under the curve was observed in pediatric patients. High p53 expression in tumor cell nuclei was observed in 6 of 12 available tissue samples. There were no objective responses; 2 participants remained stable on the study for >4 cycles.
  
  
  
  This phase I study demonstrated that p28 is well-tolerated in children with recurrent CNS malignancies at the adult recommended phase II dose.
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.) rlulla@luriechildrens.org.
authors.forename: Rishi R
authors.initials: RR
authors.lastname: Lulla
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Stewart
authors.initials: S
authors.lastname: Goldman
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Tohru
authors.initials: T
authors.lastname: Yamada
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Craig W
authors.initials: CW
authors.lastname: Beattie
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Linda
authors.initials: L
authors.lastname: Bressler
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Michael
authors.initials: M
authors.lastname: Pacini
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Ian F
authors.initials: IF
authors.lastname: Pollack
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Paul Graham
authors.initials: PG
authors.lastname: Fisher
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Roger J
authors.initials: RJ
authors.lastname: Packer
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Ira J
authors.initials: IJ
authors.lastname: Dunkel
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Girish
authors.initials: G
authors.lastname: Dhall
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Shengjie
authors.initials: S
authors.lastname: Wu
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Arzu
authors.initials: A
authors.lastname: Onar
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: James M
authors.initials: JM
authors.lastname: Boyett
authors.affiliation: Division of Hematology, Oncology, Neuro-Oncology and Stem Cell Transplant, Ann & Robert H. Lurie Children's Hospital of Chicago and Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois (R.R.L., S.G.); Division of Surgical Oncology, Department of Surgery, University of Illinois College of Medicine, Chicago, Illinois (T.Y., C.W.B.); Pharmacy Investigational Drug Service, University of Illinois Hospital and Health Sciences System, University of Illinois College of Pharmacy, Chicago, Illinois (L.B., M.P.); Department of Neurosurgery, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania (I.F.P.); Departments of Neurology, Pediatrics, Neurosurgery, and Human Biology, Stanford University, Palo Alto, California (P.G.F.); Center for Neuroscience and Behavioral Medicine, Brain Tumor Institute, Children's National Health System, Department of Neurology and Pediatrics, The George Washington University, Washington, DC (R.J.P.); Memorial Sloan Kettering Cancer Center, Department of Pediatrics, Weill Cornell Medical College, New York, New York (I.J.D.); Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Department of Pediatrics, Keck School of Medicine of University of Southern California, Los Angeles, California (G.D.); Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, Tennessee (S.W., A.O., J.M.B.); Department of Hematology-Oncology, Cincinnati Children's Hospital Medical Center, Neuro-Oncology Program, Cincinnati, Ohio (M.F.).
authors.forename: Maryam
authors.initials: M
authors.lastname: Fouladi
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D001400:Azurin / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016543:Central Nervous System Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D009367:Neoplasm Staging; D010446:Peptide Fragments / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011379:Prognosis; D016159:Tumor Suppressor Protein p53 / Q000378:metabolism*; D054875:Ubiquitination / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010446:Peptide Fragments; D016159:Tumor Suppressor Protein p53; D001400:Azurin; C561466:azurin (50-77)
keywords: azurin; central nervous system tumors; p28; pediatric; phase I.