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Pediatric  Echocardiogram  Lab  Expansion  
                                                                                   A  Summary  for  Norman  and  Susan  Hand  
                                                                                                                       Page    
                                                                                                                               
                                Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials    


Treatment  Group              ID  Number          Phase     Study  Name                                                Site  Investigator  and  
                                                                                                                       coordinator  

BRAIN  TUMORS  
Ependymoma                    PETEY  774-­        II        A  randomized,  Phase  II  study  of  single  agent        Kellie  Nazemi,  MD  
                              205                           Erlotinib  versus  oral  etoposide  in  patients  with     503-­494-­0829  
                                                            recurrent  or  refractory  pediatric  Ependymoma             
                              (OSI  )                                                                                  Rae  Acosta  RN,  CPON  
                                                                                                                       503-­418-­4467  
                                
Recurrent  Low-­Grade         RAD001              II        A  phase  II  study  of  RAD001  (Everolimus)  for         Kellie  Nazemi,  MD  
Gliomas                                                     children  with  chemotherapy  and/or  Radiation            503-­494-­0829  
                              (POETIC)                      refractory  progressive  or  recurrent  low  grade           
                                                              gliomas                                                  Rae  Acosta  RN,  CPON  
                                                                                                                       503-­418-­4467  


High  Grade  Gliomas          ACNS0621            II        Cilengitide  (EMD  12194)  in  recurrent  or               Kellie  Nazemi,  MD  
                                                            progressive  and  refractory  childhood  high  grade       503-­494-­0829  
                              (COG)                         Glioma                                                       
                                                                                                                       Rae  Acosta  RN,  CPON  
                                                                                                                       503-­418-­4467  


Childhood                 ACNS0821                II        Temozolomide  with  Irinotecan  versus                     Kellie  Nazemi,  MD  
Medulloblastoma  /  CNS                                     Temozolomide  plus  Bevacizumab  for  refractory/          503-­494-­0829  
PNET                      (COG)                             Recurrent  Medulloblastoma/CNS  PNET  of  child-­            
                                                            hood,    a  COG  Phase  II  randomized  trial              Rae  Acosta  RN,  CPON  
                                                                                                                       503-­418-­4467  


Newly  diagnosed  High        ACNS0822            I/II      A  randomized  Phase  I/II  study  of  Vorinostat          Kellie  Nazemi,  MD  
Grade  Gliomas                                              And  local  irradiation  OR  Temozolomide  and             503-­494-­0829  
                              (COG)                         Local  irradiation  OR  Bevacizumab    and  local            
                                                            Irradiation  followed  by  maintenance  Bevacizu-­         Rae  Acosta  RN,  CPON  
                                                            mab  and  Temozolomide  in  children  with  newly          503-­418-­4467  
                                                            Diagnosed  High  grade  gliomas.    

Newly  diagnosed  diffuse   ACNS0927              I/II      A  phase  I/II  study  of    Suberoylanilide  Hydrox-­     Kellie  Nazemi,  MD  
Intrinsic  Pontine  Glioma                                  amic                                                       503-­494-­0829  
(DIPG)                       (COG)                          Acid  (SAHA,Vorinostat)  and  local  irradiation,            
                                                            Followed  by  maintenance  SAHA  in  children  with        Rae  Acosta  RN,  CPON  
                                                            Newly  diagnosed  DIPG                                     503-­418-­4467  
Pediatric  Echocardiogram  Lab  Expansion  
                                                                                     A  Summary  for  Norman  and  Susan  Hand  
                                                                                                                       Page  2  
                                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials    


Treatment  Group               ID  Number          Phase     Study  Name                                                   Site  Investigator  and  
                                                                                                                           coordinator  

Solid  Tumors    
Solid  Tumors                  ADVL0813            I         A  Phase  I  study  of  IMC-­A12  (anti-­insulin-­like        Suman  Malempati,  MD  
                                                             Growth  factor-­1  Receptor  Monoclonal  antibody)              
                               (COG)                         in  combination  with  CCI-­779  (temsirolimus)  in           Rae  Acosta  RN,  CPON  
                                                             Pediatric  patients  with  recurrent  or  refractory          503-­418-­4467  
                                                             solid  tumors    

  Solid  Tumors                ADVL0815            I         A  phase  I  study  of  Pazopanib  as  a  single  agent  for   Suman  Malempati,  MD  
                                                             children  with  refractory  solid  tumors                        
                               (COG)                                                                                        Rae  Acosta  RN,  CPON  
                                                                                                                            503-­418-­4467  



Solid  Tumors  or              ADVL0816            I         A  phase  I  study  of  Obatoclax  (Pan  Anit-­               Suman  Malempati,  MD  
Leukemia                                                     Apoptotic  BCL-­2  family  small  molecule  inhibi-­            
                               (COG)                         tor),  in  combination  with  Vincristine/                    Rae  Acosta  RN,  CPON  
                                                             Doxorubicin/  Dexrazoxane,  in  children  with                503-­418-­4467  
                                                             Relapsed/Refractory  solid  tumors  or  Leukemia  


Solid  Tumors                  ADVL0821            II        A  phase  II  study  of    IMC-­A12  in  children  with       Suman  Malempati,  MD  
                                                             Relapsed  or  refractory  solid  tumors                         
                               (COG)                                                                                       Rae  Acosta  RN,  CPON  
                                                                                                                           503-­418-­4467  



Solid  Tumors  and  ALCL   ADVL0912                I/II      PF-­02341066  for  ALK  and  C-­Met  for  patients            Suman  Malempati,  MD  
                                                             with  relapsed  or  refractory  solid  tumors  and              
                           (COG)                             ALCL                                                          Rae  Acosta  RN,  CPON  
                                                                                                                           503-­418-­4467  
                                                               


Recurrent  or  Refractory   ADVL1013               I         A  Phase  I  study  of  MK-­2206,  an  AKT  inhibitor         Suman  Malempati,  MD  
Solid  Tumors  or                                            In  Pediatric  patients  with  recurrent  or  refractory        
Leukemia                    (COG)                            Solid  tumors  or  Leukemia                                   Rae  Acosta  RN,  CPON  
                                                                                                                           503-­418-­4467  
                              
Pediatric  Echocardiogram  Lab  Expansion  
                                                                                    A  Summary  for  Norman  and  Susan  Hand  
                                                                                                                      Page  3  
                                    Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials    


Treatment  Group               ID  Number          Phase     Study  Name                                                    Site  Investigator  and  
                                                                                                                            coordinator  

Solid  Tumors    
Solid  Tumors                  ADVL1011            I         A  phase  I  study  of  JAK  Inhibition  in  children          Suman  Malempati,  MD  
                                                             With  Relapsed  or  Refractory  Solid  Tumors,                   
                               (COG)                                                                                        Rae  Acosta  RN,  CPON  
                                                                                                                            503-­418-­4467  




  Solid  Tumors                ADVL0918            I         A  phase  I  study  of    of  Temsirolimus  in  combina-­      Suman  Malempati,  MD  
                                                             tion  with  Irinotecan  and  Temozolomide  in                    
                               (COG)                         children  ,  adolescents  and  young  adults  with             Rae  Acosta  RN,  CPON  
                                                             relapsed    or  refractory  solid  tumors                      503-­418-­4467  




Solid  Tumors                  AMG954-­            I                                                                        Suman  Malempati,  MD  
                               20050252                      Panitumumab  in  children  with  solid  tumors                   
                                                                                                                            Rae  Acosta  RN,  CPON  
                               (Amgen)                                                                                      503-­418-­4467  




Solid  Tumors                  ADVL0413            I         A  phase  I  study  of  the  Raf  Kinase  and  Receptor        Suman  Malempati,  MD  
                                                             Tyrosine  Kinase  Inhibitor  Sorafenib  in  children             
                               (COG)                         With  refractory  solid  tumors  or  refractory                Rae  Acosta  RN,  CPON  
                                                             Leukemia's                                                     503-­418-­4467  




Solid  Tumors                  ADVL0612            I         A  phase  I  study  of  Sunitinib  and  oral  multi-­          Suman  Malempati,  MD  
                                                             targeted  tyrosine  kinase  inhibitor,  in  children  with       
                               (COG)                         refractory  solid  tumors                                      Rae  Acosta  RN,  CPON  
                                                                                                                            503-­418-­4467  



                                                                                                                              
Pediatric  Echocardiogram  Lab  Expansion  
                                                                                      A  Summary  for  Norman  and  Susan  Hand  
                                                                                                                        Page  4  
                                Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials    


Treatment  Group              ID  Number             Phase     Study  Name                                                    Site  Investigator  and  
                                                                                                                              coordinator  

LEUKEMIA  STUDIES  
Philadelphia                  AALL0622               II        Intensified  Tyrosine  Kinase  Inhibitor  Therapy              Bill  Chang,  MD  
Chromosome  +  ALL                                             (Dasatinib)  in  Philadelphia  Chromosome  +  ALL                
                              (COG)                                                                                           Rae  Acosta  RN,  CPON  
                                                                                                                              503-­418-­4467  


  Relapsed                    KITE  2046         I/II          Bendamustine  (Treanda)  in  relapsed    pediatric             Bill  Chang,  MD  
Acute  Leukemia                                                ALL                                                              
                              (Cephalon,  Inc)                                                                                Rae  Acosta  RN,  CPON  
                                                                                                                              503-­418-­4467  



Pediatric  AML                E7373-­G000-­          Pilot     Pre-­Induction  Decitabine  Priming  for  Pediatric            Linda  Stork,  MD  
                              202                              AML  subjects                                                    
                                                                                                                              Rae  Acosta  RN,  CPON  
                              (Eisai,  Inc)                                                                                   503-­418-­4467  



Leukemia's  and               ADVL1011               I         A  phase  I  study  of  JAK  Inhibition  in  children           Suman  Malempati,  MD  
Myeloproliferative                                             With  Relapsed  or  Refractory  Solid  Tumors,                    
Neoplasm's,                   (COG)                                                                                            Rae  Acosta  RN,  CPON  
Solid  Tumors                                                                                                                  503-­418-­4467  



Ph+  Leukemia                 CA180226               II        Dasatinib  in  Children  and  Adolescents  with  Ph+           Linda  Stork,  MD  
                                                               Leukemia  with  resistance  or  Intolerance  to                  
                              (BMS)                            Imatinib                                                       Rae  Acosta  RN,  CPON  
                                                                                                                              503-­418-­4467  
                                                                 
                                                                 
                                                                 
Recurrent  or  Refractory   ADVL1013                 I         A  Phase  I  study  of  MK-­2206,  an  AKT  inhibitor          Suman  Malempati,  MD  
Solid  Tumors  or                                              In  Pediatric  patients  with  recurrent  or  refractory         
Leukemia                    (COG)                              Solid  tumors  or  Leukemia                                    Rae  Acosta  RN,  CPON  
                                                                                                                              503-­418-­4467  
                              
Pediatric  Echocardiogram  Lab  Expansion  
                                                                                    A  Summary  for  Norman  and  Susan  Hand  
                                                                                                                      Page  5  
                                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials    


Treatment  Group               ID  Number          Phase     Study  Name                                                 Site  Investigator  and  
                                                                                                                         coordinator  

LEUKEMIA  STUDIES  
Solid  Tumors  or              ADVL0816            I         A  phase  I  study  of  Obatoclax  (Pan  Anit-­             Suman  Malempati,  MD  
Leukemia                                                     Apoptotic  BCL-­2  family  small  molecule  inhibi-­          
                               (COG)                         tor),  in  combination  with  Vincristine/                  Rae  Acosta  RN,  CPON  
                                                             Doxorubicin/  Dexrazoxane,  in  children  with              503-­418-­4467  
                                                             Relapsed/Refractory  solid  tumors  or  Leukemia  
  Solid  Tumors  or            ADVL0413            I         A  phase  I  study  of  the  Raf  Kinase  and  Receptor     Suman  Malempati,  MD  
  Refractory  Leukemia                                       Tyrosine  Kinase  Inhibitor  Sorafenib  in  children          
                               (COG)                         With  refractory  solid  tumors  or  refractory             Rae  Acosta  RN,  CPON  
(AML  and  FLT3-­ITD                                         Leukemia's                                                  503-­418-­4467  
mutation)                                                      
CD-­22  +  Leukemia            ADVL04P2            I/II      A  phase  I/II  pilot  study  of  Chemoimmunotherapy   Suman  Malempati,  MD  
                                                             With  Epratuzumab  for  children  with  Relapsed         
                               (COG)                         CD-­22  +  ALL                                         Rae  Acosta  RN,  CPON  
                                                                                                                    503-­418-­4467  


Rhabdomyosarcoma  Studies    
    
High  Risk                     ARST08P1            Pilot     A  pilot  study  to  evaluate  novel  agents                Suman  Malempati,  MD  
Rhabdomyocarcoma                                             (Temozolomide  and  Cixutumumab)  in                          
                               (COG)                         combination  with  intensive  multi-­agent  interval        Rae  Acosta  RN,  CPON  
                                                             Compressed  therapy  for  patients  with  high  risk        503-­418-­4467  
                                                             Rhabdomyosarcoma  
                                                               
                                                               
                                                               
Rhabdomyosarcoma               ARST0921            II        A  randomized  Phase  II  trial  of  Bevacizumab            Suman  Malempati,  MD  
                                                             (Avastin)  and  Temsirolimus  (Torisol)  in                   
                               (COG)                         Combination  with  IV  Vinorelbine  and                     Rae  Acosta  RN,  CPON  
                                                             Cyclophosphamide  in  subjects  with  recurrent  or         503-­418-­4467  
                                                             Refractory  Rhabdomyosarcoma  
Pediatric  Echocardiogram  Lab  Expansion  
                                                                                     A  Summary  for  Norman  and  Susan  Hand  
                                                                                                                       Page  6  
                                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials    


Treatment  Group               ID  Number           Phase     Study  Name                                                   Site  Investigator  and  
                                                                                                                            coordinator  

Bonemarrow  and  stem  cell  transplant  protocols  
  Severe  aplastic  anemia     BMT  CTN             I/II      Fludarabine-­based  conditioning  for  allogeneic             Gabrielle  Meyers,  MD  
                               0301                           marrow  transplantation  from  HLA  compatible                503-­494-­1551  
                                                              unrelated  donors  in  severe  aplastic  anemia                 
                               (BMT  CTN)                                                                                   Allison  Moore    RN  
                                                                                                                            503-­418-­5341  

  Hodgkins  disease  and   BUMELTT                  II        A  phase  II  study  to  evaluate  the  safety  and           Richard  Maziarz,  MD  
non-­hodgkins  lymphoma                                       efficacy  of  IV  busulfan,  melphalan,  and  thiotepa        503-­494-­1551  
                           (OHSU)                             (BuMelTT)  regimen  followed  by  autologous                    
                                                              PBSC  infusion  for  patients  with  hodgkins  disease        Allison  Moore  RN  
                                                              and  non-­hodgkins  lymphoma                                  503-­418-­5341l  


Hematologic                    BU/FLU/TBI           I/II      A  Phase  I/Il  non-­myeloablative  allogenic                 Richard  Maziarz,  MD  
malignancies                                                  Hematopoietic  stem  cell  transplant  for  the               503-­494-­1551  
                               (OHSU)                         Treatment  of  patients  with  hematologic  malig-­             
                                                              nancies  using  busulfan,  fludarbine  and  total  body       Allison  Moore    RN  
                                                              irradiation                                                   503-­418-­5341  


Hematologic                    T2008-­005           I         Phase  I  feasibility  study  of  clofarabine  and  low       Eneida  Nemecek,  MD  
malignancies                                                  dose  total  body  irradiation  (TBI)  as  a  non-­           503-­494-­0829  
                               (TACL)                         Myeloblative  preperative  regimen  for  stem  cell             
                               Multicenter                    transplant  (SCT)  for  hematologic  malignancies             Allison  Moore    RN  
                                                                                                                            503-­418-­5341  


Ph+  Leukemia                  FHCRC  2223          I/II      A  multicenter  phase  I/II  study  of  the  prophylactic     Michael  Mauro,  MD  
                                                              inhibition  of  BCR-­ABL  tyrosine  kinase  by                503-­494-­1551  
                               (FHCRC)                        Tasigna  (Nilotinib)  after  HSCT  for  Ph+  leukemia           
                                                                                                                            Allison  Moore    RN  
                                                                                                                            503-­418-­5341  


Interstitial  pneumonia        ASCT0521             II        Soluble  tumor  necrosis  factor:  Enbrel                     Bill  Chang,  MD  
Syndrome  following                                           (Etanercept)  for  the  treatment  of  acute  non-­           503-­494-­0829  
Allogeneic  stem  cell         (COG)                          infectious  pulmonary  dysfunction  (interstitial               
transplant                                                    pneumonia  syndrome)  following  allogeneic  stem             Allison  Moore    RN  
                                                              cell  transplantation.                                        503-­418-­5341  

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Doernbecher clinical trials april 2011

  • 1. Pediatric  Echocardiogram  Lab  Expansion   A  Summary  for  Norman  and  Susan  Hand     Page                     Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials     Treatment  Group   ID  Number   Phase   Study  Name     Site  Investigator  and   coordinator   BRAIN  TUMORS   Ependymoma     PETEY  774-­ II   A  randomized,  Phase  II  study  of  single  agent     Kellie  Nazemi,  MD   205     Erlotinib  versus  oral  etoposide  in  patients  with   503-­494-­0829     recurrent  or  refractory  pediatric  Ependymoma       (OSI  )   Rae  Acosta  RN,  CPON     503-­418-­4467     Recurrent  Low-­Grade   RAD001   II   A  phase  II  study  of  RAD001  (Everolimus)  for   Kellie  Nazemi,  MD   Gliomas     children  with  chemotherapy  and/or  Radiation   503-­494-­0829   (POETIC)   refractory  progressive  or  recurrent  low  grade      gliomas   Rae  Acosta  RN,  CPON   503-­418-­4467   High  Grade  Gliomas     ACNS0621   II   Cilengitide  (EMD  12194)  in  recurrent  or     Kellie  Nazemi,  MD     progressive  and  refractory  childhood  high  grade   503-­494-­0829   (COG)   Glioma     Rae  Acosta  RN,  CPON   503-­418-­4467   Childhood     ACNS0821   II   Temozolomide  with  Irinotecan  versus     Kellie  Nazemi,  MD   Medulloblastoma  /  CNS     Temozolomide  plus  Bevacizumab  for  refractory/   503-­494-­0829   PNET   (COG)   Recurrent  Medulloblastoma/CNS  PNET  of  child-­   hood,    a  COG  Phase  II  randomized  trial     Rae  Acosta  RN,  CPON   503-­418-­4467   Newly  diagnosed  High   ACNS0822   I/II   A  randomized  Phase  I/II  study  of  Vorinostat   Kellie  Nazemi,  MD   Grade  Gliomas       And  local  irradiation  OR  Temozolomide  and     503-­494-­0829   (COG)   Local  irradiation  OR  Bevacizumab    and  local       Irradiation  followed  by  maintenance  Bevacizu-­ Rae  Acosta  RN,  CPON   mab  and  Temozolomide  in  children  with  newly   503-­418-­4467   Diagnosed  High  grade  gliomas.     Newly  diagnosed  diffuse   ACNS0927   I/II   A  phase  I/II  study  of    Suberoylanilide  Hydrox-­ Kellie  Nazemi,  MD   Intrinsic  Pontine  Glioma     amic   503-­494-­0829   (DIPG)     (COG)   Acid  (SAHA,Vorinostat)  and  local  irradiation,         Followed  by  maintenance  SAHA  in  children  with   Rae  Acosta  RN,  CPON     Newly  diagnosed  DIPG     503-­418-­4467  
  • 2. Pediatric  Echocardiogram  Lab  Expansion   A  Summary  for  Norman  and  Susan  Hand     Page  2                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials     Treatment  Group   ID  Number   Phase   Study  Name     Site  Investigator  and   coordinator   Solid  Tumors     Solid  Tumors     ADVL0813   I   A  Phase  I  study  of  IMC-­A12  (anti-­insulin-­like   Suman  Malempati,  MD     Growth  factor-­1  Receptor  Monoclonal  antibody)     (COG)   in  combination  with  CCI-­779  (temsirolimus)  in     Rae  Acosta  RN,  CPON   Pediatric  patients  with  recurrent  or  refractory   503-­418-­4467   solid  tumors      Solid  Tumors     ADVL0815   I   A  phase  I  study  of  Pazopanib  as  a  single  agent  for   Suman  Malempati,  MD     children  with  refractory  solid  tumors       (COG)   Rae  Acosta  RN,  CPON   503-­418-­4467   Solid  Tumors  or   ADVL0816   I   A  phase  I  study  of  Obatoclax  (Pan  Anit-­ Suman  Malempati,  MD   Leukemia     Apoptotic  BCL-­2  family  small  molecule  inhibi-­   (COG)   tor),  in  combination  with  Vincristine/ Rae  Acosta  RN,  CPON   Doxorubicin/  Dexrazoxane,  in  children  with   503-­418-­4467   Relapsed/Refractory  solid  tumors  or  Leukemia   Solid  Tumors   ADVL0821   II   A  phase  II  study  of    IMC-­A12  in  children  with     Suman  Malempati,  MD     Relapsed  or  refractory  solid  tumors     (COG)   Rae  Acosta  RN,  CPON   503-­418-­4467   Solid  Tumors  and  ALCL   ADVL0912   I/II   PF-­02341066  for  ALK  and  C-­Met  for  patients   Suman  Malempati,  MD     with  relapsed  or  refractory  solid  tumors  and     (COG)   ALCL   Rae  Acosta  RN,  CPON     503-­418-­4467     Recurrent  or  Refractory   ADVL1013   I   A  Phase  I  study  of  MK-­2206,  an  AKT  inhibitor   Suman  Malempati,  MD   Solid  Tumors  or     In  Pediatric  patients  with  recurrent  or  refractory     Leukemia   (COG)   Solid  tumors  or  Leukemia     Rae  Acosta  RN,  CPON     503-­418-­4467    
  • 3. Pediatric  Echocardiogram  Lab  Expansion   A  Summary  for  Norman  and  Susan  Hand     Page  3                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials     Treatment  Group   ID  Number   Phase   Study  Name     Site  Investigator  and   coordinator   Solid  Tumors     Solid  Tumors     ADVL1011   I   A  phase  I  study  of  JAK  Inhibition  in  children   Suman  Malempati,  MD     With  Relapsed  or  Refractory  Solid  Tumors,       (COG)     Rae  Acosta  RN,  CPON   503-­418-­4467    Solid  Tumors     ADVL0918   I   A  phase  I  study  of    of  Temsirolimus  in  combina-­ Suman  Malempati,  MD     tion  with  Irinotecan  and  Temozolomide  in       (COG)   children  ,  adolescents  and  young  adults  with     Rae  Acosta  RN,  CPON   relapsed    or  refractory  solid  tumors     503-­418-­4467   Solid  Tumors     AMG954-­ I   Suman  Malempati,  MD     20050252   Panitumumab  in  children  with  solid  tumors         Rae  Acosta  RN,  CPON   (Amgen)   503-­418-­4467   Solid  Tumors   ADVL0413   I   A  phase  I  study  of  the  Raf  Kinase  and  Receptor   Suman  Malempati,  MD     Tyrosine  Kinase  Inhibitor  Sorafenib  in  children     (COG)   With  refractory  solid  tumors  or  refractory     Rae  Acosta  RN,  CPON   Leukemia's   503-­418-­4467   Solid  Tumors     ADVL0612   I   A  phase  I  study  of  Sunitinib  and  oral  multi-­ Suman  Malempati,  MD     targeted  tyrosine  kinase  inhibitor,  in  children  with     (COG)   refractory  solid  tumors     Rae  Acosta  RN,  CPON     503-­418-­4467            
  • 4. Pediatric  Echocardiogram  Lab  Expansion   A  Summary  for  Norman  and  Susan  Hand     Page  4                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials     Treatment  Group   ID  Number   Phase   Study  Name     Site  Investigator  and   coordinator   LEUKEMIA  STUDIES   Philadelphia     AALL0622   II   Intensified  Tyrosine  Kinase  Inhibitor  Therapy   Bill  Chang,  MD   Chromosome  +  ALL     (Dasatinib)  in  Philadelphia  Chromosome  +  ALL     (COG)   Rae  Acosta  RN,  CPON   503-­418-­4467    Relapsed     KITE  2046   I/II   Bendamustine  (Treanda)  in  relapsed    pediatric     Bill  Chang,  MD   Acute  Leukemia     ALL     (Cephalon,  Inc)   Rae  Acosta  RN,  CPON   503-­418-­4467   Pediatric  AML   E7373-­G000-­ Pilot   Pre-­Induction  Decitabine  Priming  for  Pediatric   Linda  Stork,  MD   202   AML  subjects         Rae  Acosta  RN,  CPON   (Eisai,  Inc)   503-­418-­4467   Leukemia's  and   ADVL1011   I   A  phase  I  study  of  JAK  Inhibition  in  children   Suman  Malempati,  MD   Myeloproliferative     With  Relapsed  or  Refractory  Solid  Tumors,       Neoplasm's,     (COG)     Rae  Acosta  RN,  CPON   Solid  Tumors   503-­418-­4467   Ph+  Leukemia     CA180226   II   Dasatinib  in  Children  and  Adolescents  with  Ph+   Linda  Stork,  MD     Leukemia  with  resistance  or  Intolerance  to       (BMS)   Imatinib   Rae  Acosta  RN,  CPON       503-­418-­4467           Recurrent  or  Refractory   ADVL1013   I   A  Phase  I  study  of  MK-­2206,  an  AKT  inhibitor   Suman  Malempati,  MD   Solid  Tumors  or     In  Pediatric  patients  with  recurrent  or  refractory     Leukemia   (COG)   Solid  tumors  or  Leukemia     Rae  Acosta  RN,  CPON     503-­418-­4467    
  • 5. Pediatric  Echocardiogram  Lab  Expansion   A  Summary  for  Norman  and  Susan  Hand     Page  5                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials     Treatment  Group   ID  Number   Phase   Study  Name     Site  Investigator  and   coordinator   LEUKEMIA  STUDIES   Solid  Tumors  or     ADVL0816   I   A  phase  I  study  of  Obatoclax  (Pan  Anit-­ Suman  Malempati,  MD   Leukemia     Apoptotic  BCL-­2  family  small  molecule  inhibi-­   (COG)   tor),  in  combination  with  Vincristine/ Rae  Acosta  RN,  CPON   Doxorubicin/  Dexrazoxane,  in  children  with   503-­418-­4467   Relapsed/Refractory  solid  tumors  or  Leukemia    Solid  Tumors  or   ADVL0413   I   A  phase  I  study  of  the  Raf  Kinase  and  Receptor   Suman  Malempati,  MD    Refractory  Leukemia     Tyrosine  Kinase  Inhibitor  Sorafenib  in  children       (COG)   With  refractory  solid  tumors  or  refractory     Rae  Acosta  RN,  CPON   (AML  and  FLT3-­ITD   Leukemia's   503-­418-­4467   mutation)     CD-­22  +  Leukemia   ADVL04P2   I/II   A  phase  I/II  pilot  study  of  Chemoimmunotherapy   Suman  Malempati,  MD     With  Epratuzumab  for  children  with  Relapsed       (COG)   CD-­22  +  ALL   Rae  Acosta  RN,  CPON   503-­418-­4467   Rhabdomyosarcoma  Studies         High  Risk     ARST08P1   Pilot   A  pilot  study  to  evaluate  novel  agents     Suman  Malempati,  MD   Rhabdomyocarcoma     (Temozolomide  and  Cixutumumab)  in       (COG)     combination  with  intensive  multi-­agent  interval   Rae  Acosta  RN,  CPON   Compressed  therapy  for  patients  with  high  risk   503-­418-­4467   Rhabdomyosarcoma         Rhabdomyosarcoma   ARST0921   II   A  randomized  Phase  II  trial  of  Bevacizumab   Suman  Malempati,  MD     (Avastin)  and  Temsirolimus  (Torisol)  in       (COG)   Combination  with  IV  Vinorelbine  and     Rae  Acosta  RN,  CPON   Cyclophosphamide  in  subjects  with  recurrent  or     503-­418-­4467   Refractory  Rhabdomyosarcoma  
  • 6. Pediatric  Echocardiogram  Lab  Expansion   A  Summary  for  Norman  and  Susan  Hand     Page  6                 Doernbecher  Pediatric  Oncology  Phase  I  &  II  trials     Treatment  Group   ID  Number   Phase   Study  Name     Site  Investigator  and   coordinator   Bonemarrow  and  stem  cell  transplant  protocols    Severe  aplastic  anemia   BMT  CTN   I/II   Fludarabine-­based  conditioning  for  allogeneic   Gabrielle  Meyers,  MD   0301   marrow  transplantation  from  HLA  compatible   503-­494-­1551     unrelated  donors  in  severe  aplastic  anemia     (BMT  CTN)   Allison  Moore    RN   503-­418-­5341    Hodgkins  disease  and   BUMELTT   II   A  phase  II  study  to  evaluate  the  safety  and     Richard  Maziarz,  MD   non-­hodgkins  lymphoma     efficacy  of  IV  busulfan,  melphalan,  and  thiotepa     503-­494-­1551   (OHSU)   (BuMelTT)  regimen  followed  by  autologous     PBSC  infusion  for  patients  with  hodgkins  disease   Allison  Moore  RN   and  non-­hodgkins  lymphoma   503-­418-­5341l   Hematologic     BU/FLU/TBI   I/II   A  Phase  I/Il  non-­myeloablative  allogenic     Richard  Maziarz,  MD   malignancies     Hematopoietic  stem  cell  transplant  for  the     503-­494-­1551   (OHSU)   Treatment  of  patients  with  hematologic  malig-­     nancies  using  busulfan,  fludarbine  and  total  body   Allison  Moore    RN   irradiation   503-­418-­5341   Hematologic     T2008-­005   I   Phase  I  feasibility  study  of  clofarabine  and  low   Eneida  Nemecek,  MD   malignancies     dose  total  body  irradiation  (TBI)  as  a  non-­   503-­494-­0829   (TACL)     Myeloblative  preperative  regimen  for  stem  cell     Multicenter   transplant  (SCT)  for  hematologic  malignancies   Allison  Moore    RN   503-­418-­5341   Ph+  Leukemia     FHCRC  2223   I/II   A  multicenter  phase  I/II  study  of  the  prophylactic   Michael  Mauro,  MD     inhibition  of  BCR-­ABL  tyrosine  kinase  by     503-­494-­1551   (FHCRC)     Tasigna  (Nilotinib)  after  HSCT  for  Ph+  leukemia       Allison  Moore    RN   503-­418-­5341   Interstitial  pneumonia     ASCT0521   II   Soluble  tumor  necrosis  factor:  Enbrel   Bill  Chang,  MD   Syndrome  following       (Etanercept)  for  the  treatment  of  acute  non-­ 503-­494-­0829   Allogeneic  stem  cell   (COG)   infectious  pulmonary  dysfunction  (interstitial     transplant   pneumonia  syndrome)  following  allogeneic  stem   Allison  Moore    RN   cell  transplantation.     503-­418-­5341