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Phase i list dec 7

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Phase i list dec 7

  1. 1. Doernbecher Pediatric Oncology Phase I & II Study list December 7, 2010 Study Name & description Amend# eIRB# Phase EligibilityRAD001 A Phase II Study of RAD001 (Everolimus) for Children 2 v.3 6555 II Reservation required prior to consent. with Chemotherapy and/or Radiation Refractory Astrocytoma, Pilocytic Astrocytoma, Progressive or Recurrent Low-Grade Gliomas CNS High grade glioma, Oligodendroglioma, Infantile Age > 3 years < 21 years desmoplastic astrocytoma, mixed glioma, pleomorphic xanthoastrocytoma, gangliogliomaACNS0221 A Phase II Study of Conformal Radiotherapy in 11/15/05 3781 II CNS High Grade Glioma Patients with Low-Grade Gliomas < 21 years of ageACNS0621 Cilengitide (EMD 121974) (IND# 59073) in Recurrent 3 4841 II Reservation required. **Temporarily or Progressive and Refractory Childhood High-Grade Closed as of 8/30/2010** Glioma CNS High Grade Glioma < 21 years of ageADVL04P2 A Phase I/II Pilot Study of Chemoimmunotherapy 6 1211 I/II Part A closed permanently. Part B with Epratuzumab for Children with Relapsed CD- (Group-wide Phase 2 Pilot) now open. 22-Positive ALL be ≥ 2 years and ≤ 31 years of ageADVL0413 A Phase I Study of the Raf Kinase and Receptor 7A 3023 I Part C open to AML and FLT3-ITD Tyrosine Kinase Inhibitor Sorafenib in Children with mutation. PK mandatory. Part A & B Refractory Solid Tumors or Refractory Leukemias completed. ≥ 24 months and < 21 years of ageADVL0612 A Phase I Study of Sunitinib (SU11248), and Oral 4 3361 I Check with Rae or Amanda to see if Multi-Targeted Tyrosine Kinase Inhibitor, in children there are any open reservations with Refractory Solid Tumors Solid tumors including CNS Tumors ≥ 2 years of age and < 21 years of ageADVL0813 A Phase I study of IMC-A12 (Anti-Insulin-Like 3 5341 I Check with Rae or Amanda to see if Growth Factor-1 Receptor Monoclonal Antibody) in there are any open reservations Combination with CCI-779 (Temsirolimus) in Solid tumors including CNS tumors Pediatric Patients with Recurrent or Refractory Solid Tumors > than 12 months and < 21 years of ageADVL0815 A Phase 1 Study of Pazopanib as a Single Agent 1A 5544 I Per COG, as of 5/7/2010; Part 1 not for Children with Refractory Solid Tumors scheduled to re-open unless replacement is needed. Part 2 will > than 12 months and < 21 years of age open when Part 1 is completed. Part 2 is for Solid tumors expanded Imaging cohort with at least 2 cm tumorADVL0816 A Phase 1 Study of Obatoclax (Pan Anti-Apoptotic 3 5553 I Amendment #3 Approved BCL-2 Family Small Molecule Inhibitor), in Excluding Primary CNS or pts with Combination with known CNS metastases Vincristine/Doxorubicin/Dexrazoxane, in Children with Relapsed/Refractory Solid Tumors or Leukemia Temporarily Closed > than 6 months and < 21 years of age
  2. 2. Doernbecher Pediatric Oncology Phase I & II Study listADVL0819 A Phase 1 Study of SAHA and Temozolomide in 1B 6287 I Check with Rae or Amanda to see if Children with Relapsed or Refractory Primary Brain there are any open reservations or Spinal Cord Tumors Temporarily Closed > than 12 months and < 21 years of ageADVL0821 A Phase II study of IMC-A12 in Children with 5 5095 II Check with Rae or Amanda to see if Relapsed/Refractory Solid Tumors there are any open reservations Only cohorts for Retinoblastoma, > 6 month and < 30 years of age neuroblastoma, and adrenocortical carcinoma are open.ADVL0912 PF-02341066 for ALK and C-Met for patients with 2 5871 I/2 Check with Rae or Amanda to see if there are any open reservations Relapsed/Refractory Solid Tumors and ALCL Only the cohort with confirmed ALK > than 12 months and < 21 years of age fusion proteins is open.ADVL0916 A Phase I Study of Vorinostat and Bortezomib in 2 5848 I Check with Rae or Amanda to see if Children with Recurrent or Refractory Solid Tumors, there are any open reservations including CNS Tumors and Lymphomas > than 12 months and < 21 years of age Temporarily ClosedADVL0918 A Phase 1 Study of Temsirolimus in Combination Orig 6519 I Check with Rae or Amanda to see if with Irinotecan and Temozolomide in Children, there are any open reservations Adolescents, and Young Adults with Relapsed or Including CNS tumors Refractory Solid Tumors > than 12 months and < 21 years of ageADVL0919 A PHASE 1 STUDY OF RO4929097, AN ORAL 1B 5848 I Check with Rae or Amanda to see if SMALL MOLECULE INHIBITOR OF there are any open reservations GAMMA-SECRETASE, IN CHILDREN WITH RELAPSED/REFRACTORY SOLID OR CNS TUMORS, LYMPHOMA, OR T-CELL LEUKEMIA > than 12 months and < 21 years of ageAMG954 20050252, A Phase I Study to Evaluate th Safety Orig 5456 I Check with Rae or Amanda to see if and PKs of Panitumumab in Children with Solid there are any open reservations Tumors 1 to < 18 years of ageBMS A Phase II Study of Dasatinib Therapy in Children and 3 4971 II Check with Rae or Amanda to see if there arCA180226 Adolescents with Ph+ Leukemia with Resistance or reservations Intolerance to Imatinib >1 to < 21AALL0622 Intensified Tyrosine Kinase Inhibitor Therapy 5 4876 III Open group wide (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive ALL > 1 year and ≤ 30 yearsADVL1011 JAK Inhibition (INCB018424) in Children with Relapsed or Orig 6814 I Check with Rae or Amanda to see if there ar Refractory Solid Tumors, Leukemias, and reservations Myeloproliferative Neoplasms > than 12 months and < 21 years of age

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