Duke Pediatric Fast Facts
Duke Comprehensive Cancer Center
Clinical Trials at Duke Comprehensive Cancer Center
November 23, 2009

Pediatric Brain Tumor
Sponsor Sponsor ID Protocol Phase Eligibility Contact IRB#
PBTC    A Phase I Study of ABT-888, an Oral Inhibitor of Poly(ADP-ribose) Polymerase and Temozolomide in Children with Recurrent/Refractory CNS Tumors SBR Selection: * Will any Duke Medicine facility be a performance site? Yes No Does this study   I   919- 668-6728  00018926 
Merck    A Phase I Study of MK-0752 in Pediatric Patients with Recurrent or Refractory CNS Malignancies   I   919- 668-6728  00014101 
COG    A Phase II Study of Conformal Radiotherapy in Patients with Low-Grade Glimoas (ACNS0221)   II   919- 668-6728  00000052 
PBTC  PBTC-021  A Phase I Trial of Capecitabine Rapidly Disintegrating Tablets and Concomitant Radiation Therapy in Children with Newly Diagnosed Brainstem Gliomas and High Grade Gliomas (PBTC-021)   I   919- 668-6728  00000294 
Duke-NCI  07174  Evaluation of Cerebral Spinal Fluid (CSF) Proteome and Angiogenesis Proteins in Children with Newly Diagnosed Central Nervous System (CNS) Tumors  I/II Newly diagnosed CNS Tumors  919- 668-6728  00000505 
COG  ANBL00P3  Phase III Randomized Trial of IV Gammaglobulin Therapy for Patients with Neuroblastoma Associated Opsoclonus-Myoclonusataxia Syndrome Treated with CT and Prednisone  III   919- 668-6728  00010800 
PBTC  PBTC-014  PBTC-014: Phase I/II Trial of R115777 and XRT in Pediatric Patients with Newly Diagnosed Non-Disseminated Intrinsic Diffuse Brainstem Gliomas.   I/II >=3 - <= 21 yrs  919- 668-6728  00008017 
COG  ACNS0122  COG ACNS0122: Phase II Study to Assess the Ability of Neoadjuvant CT +/- Second Look Surgery to Eliminate All Measurable Disease Prior to RT for NGGCT  II 3 to < 25 yrs; New dx  919- 668-6728  00007357 
PBTC  PBTC-016  PBTC-016: Phase I, Molecular Biology and Phase II Study of Lapatinib (GW572016) in Pediatric Patients with Recurrent or Refractory Medulloblastoma, Malignant Glioma or Ependymoma.  I/II <=21 yrs; 3 wk prior CT window  919- 668-6728  00004779 
St Jude  SJMB03  Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor or Atypical Teratoid Rhabdoid Tumor  II 3 - 21 yrs; New dx  919- 668-6728  00006531 
PBTC  PBTC018  A Phase I Trial of CC-5013 (Lenalidomide) in Pediatric Patients with Recurrent or Refractory Primary CNS Tumors  I <=21 yrs  919- 668-6728  00013541 
NCI  PBTC-020  A Phase I Clinical Trail of AZD2171 in Children with Recurrent or Progressive Central Nervous System (CNS) Tumors   I <=21 yrs  919- 668-6728  00009530 
PBTC  PBTC019  PBTC-019 A Phase I Pharmacokinetic Optimal Dosing Study of Intrathecal Topotecan for Childern with Neoplastic Meningitis  I >=3 yrs <= 21 yrs  919- 668-6728  00011956 
Pediatric Leukemias and Myelproliferative Syndrome
COG  AALL0331  Standard Risk B-Precursor Acute Lymphoblastic Leukemia (Amend #1A) (AALL0331)   III New diagnosis; 1- <10 yrs  919- 668-6728  00008611 
Duke  05164  A Pilot Trial of Unrelated Umbilical Cord Blood Transplantation (UCBT) Augmented with Cytokine-Primed Aldehyde Dehydrogenase-Bright (ALDHbr) Cells   Pilot/Feasibility 4,5 or 6/6 match unrelated UCB  919- 668-6728  00008970 
COG  AALL02P2  COG AALL02P2: Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia (ALL)  Pilot/Feasibility >= 18 yrs < 30  919- 668-6728  00006732 
COG  ALL00P2  COG ALL00P2: Use of Modified BFM +/- Compound 506U78 in an Intensive Chemotherapy Regimen for the Treatment of T-Cell Leukemia  Pilot/Feasibility New dx  919- 668-6728  00007000 
BMT CTN  0501  Multicenter, Open Label, Randomized Trial Comparing Single versus Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients with High Risk Leukemia and Myelodysplasia   III 3-6 HLA donor match; 2-21 yrs  919- 668-6728  00010474 
Pediatric Lymphoma
COG  ANHL0131  COG ANHL0131: A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) Versus Consolidation with a Regimen Including Vinblastine.  III <21 yrs; New dx  919- 668-6728  00006752 
POG  A5971  POG A5971: Randomized Phase III Study for the Treatment of Newly Diagnosed Disseminated Lymphoblastic Lymphoma or Localized Lymphoblastic Lymphoma.  III New dx  919- 668-6728  00006472 
Pediatric Neuroblastoma and Embryonal Tumor
COG    ANBL0531 Response and Biology Based Therapy for Intermediate Risk Neuroblastoma  III   919- 668-6728  00006092 
COG  ANBL00P2  COG ANBL00P2: Perinatal Neuroblastoma: Expectant Observation  Pilot/Feasibility No CT/abd surgery  919- 668-6728  00010288 
COG  AGCT0132  COG AGCT0132: A Phase III Study of Reduced Therapy in Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors  III <=21yr  919- 668-6728  00007282 
Pediatric Phase I and II Clinical Trials
BMT CTN    Unrelated Donor Hematopoietic Cell Transplantation for Children with Severe Sickle Cell Disease Using a Reduced Intensity Conditioning Regimen  II   919- 668-6728  00008471 
Duke  07113  A Prospective, Phase I/II Trial Determining the Efficacy and Safety of Allogeneic Hematopietic Stem Cell Transplantation Using Banked Unrealted Umbilical Cord Blood Supplemented with Related, Haplo-Identical T-Cell Depleted Stem Cells in Patients with H  I/II <55. 3/6 or 4/6 donor & 3,4,5, or 6/6 unrelat UCB  919- 668-6728  00008292 
Pediatric Sarcoma
COG    Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS) ARST0531   III   919- 668-6728  00001189 
COG    ARST0332 Risk Based Treatment for Pediatric Non-Rhabdomysarcoma Soft Tissue Sarcomas (NRSTS)   III   919- 668-6728  00001918 
COG  AOST0221  COG AOSTO221: A Phase II Study of Aerosolized GM-CSF (NSC#613795, IND 11042) in Osteosarcoma Patients with First Pulmonary Recurrence of Osteosarcoma  II <= 39 yrs  919- 668-6728  00005776 
COG  ARST0321  COG ARST0321: Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy.  II 4 wk CT window; <= 18 yrs  919- 668-6728  00008598 
COG  ARST0331  COG ARST0331: Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma  III Low risk embryonjal/botryoid/spindle cell; <50 yr  919- 668-6728  00006597 
COG  ARST0121  COG ARST0121: A Groupwide Randomized Phase II Window Study of Two Different Schedules of Irinotecan in Combination with Vincristine and Pilot Assessment of Safety and Efficacy of Tirapazamine Combined with Multiagent CT for First Relapse or Progressive D  II <= 1 prior CT  919- 668-6728  00004533 
Pediatric Wilms' Tumor
COG    AREN0533 Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumor   III   919- 668-6728  00010187