1. Doernbecher Pediatric Oncology Phase I & II Study list
December 7, 2010
Study Name & description Amend# eIRB# Phase Eligibility
RAD001 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, ganglioglioma
ACNS0221 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 age
ACNS0621 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 age
ADVL04P2 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 age
ADVL0413 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 age
ADVL0612 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 age
ADVL0813 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 age
ADVL0815 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
tumor
ADVL0816 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. Doernbecher Pediatric Oncology Phase I & II Study list
ADVL0819 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 age
ADVL0821 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 Closed
ADVL0918 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 age
ADVL0919 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 age
AMG954 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 age
BMS A Phase II Study of Dasatinib Therapy in Children and 3 4971 II Check with Rae or Amanda to see if there ar
CA180226 Adolescents with Ph+ Leukemia with Resistance or reservations
Intolerance to Imatinib
>1 to < 21
AALL0622 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 years
ADVL1011 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