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Pediatric Clinical Trials

Hematology-Oncology

Hematology

KIDSDOTT: Prospective Multi-Center Evaluation of the Duration of Therapy for Thrombosis in Children (the “Kids-DOTT” Trial)

Principal Investigator: Courtney Thornburg, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor:  University of Colorado, Denver

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00020610

NCT Number: NCT00687882

Contact:
For more information, please contact Courtney Thornburg, MD at 919-684-3401.


Pharmacokinetics and Relative Bioavailability of a Liquid Formulation of Hydroxyurea in Pediatric Patients with Sickle Cell Anemia

Principal Investigator: Courtney Thornburg, MD
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: Children's Mercy Hospital Kansas City

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00030005

NCT Number: NCT01506544

Contact:
For more information, please contact Courtney Thornburg, MD at 919-684-3401.


PETIT: A Three Part, staggered Cohort, Open-label and Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinietics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients with Chronic Idiopathic Thrombocytopenic Purpura (ITP).

Principal Investigator: Courtney Thornburg, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: GlaxoSmithCline

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00020572

NCT Number: NCT00908037

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


Partial/Total Splenectomy for Children with Congenital Hemolytic Anemia Registry (SCCHAR)

Principal Investigator: Courtney Thornburg, MD
Category: Pediatric Hematology-Oncology 
Phase: N/A
Sponsor: PI Initiated

Purpose:
2  to 16 years, 9months old: The purpose of this study is to try to better understand the result of a child with congenital hemolytic anemia undergoing surgery. For some children with anemia, either a total splenectomy or partial splenectomy is used as part of their care. This study is a multicenter registry (data collection from many institutions) to compare the results of these two surgical procedures

IRB Number: Pro00021114

Contact:
For more information, please contact Courtney Thornburg, MD at 919-684-3401.


TWITCH: TCD with Transfusions Changing to Hydroxyurea (TWiTCH): A Phase III Randomized Clinical Trial to Compare Standard Therapy (Erythrocyte Transfusions) to alteRN Clinical Research Coordinatorative Therapy (Hydroxyurea) for the Prevention of Primary Stroke in Pediatric Subjects with Sickle Cell Anemia and Abnormal TCD Velocities

Principal Investigator: Jennifer Rothman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Baylor College of Medicine

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00020840

NCT Number: NCT01425307

Contact:
For more information, please contact Jennifer Rothman, MD at 919-684-3401.


Oncology

ANHL04B1 Rare and Cutaneous Non-Hodgkin Lymphoma Registry

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00000017

NCT Number: NCT01000753

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AOST0331 A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy-A Phase II Intergroup Study

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00000079

NCT Number: NCT00134030

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AREN03B2 Renal Tumors Classification, Biology, and Banking Study

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00000480

NCT Number: NCT00898365

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AREN0321 Treatment of High Risk Renal Tumors

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00001128

NCT Number: NCT01000753

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AALL0434: Intensified Methotrexate, Nelarabine Compound 506U78; IND# 52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00001130

NCT Number: NCT00408005

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ARST0531 Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC AlteRN Clinical Research Coordinatorating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00001189

NCT Number: NCT00354835

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AREN0532 Treatment for Very Low, Low Risk and Standard Risk Favorable Histology Wilms Tumors

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00001565

NCT Number: NCT00352534

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ARST0332:  Risk Based Treatmnt for Pediatric Non-rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS)

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00001918

NCT Number: NCT00346164

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


Erwinase Master Treatment Protocol

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Phoenix Children's Hospital

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00004560

NCT Number: NCT00904241

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ANBL00B1 Neuroblastoma Biology Studies

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00000017

NCT Number: NCT01000753

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


D9902: A COG Soft Tissue Sarcoma Biology and Banking Protocol

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00004919

NCT Number: NCT00919269

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


Protocol for the Enrollment on the Official COG Registry, The Childhood Cancer Research Network (CCRN Clinical Research Coordinator)

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: National Cancer Institute

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00005257

NCT Number: NCT01117168

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


Phase III Randomized Trail of Single vs. Tandem Myeloablative Consolidation Therapy for High Risk Neuroblastoma

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00005397

NCT Number: NCT00567567

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AEWS07B1: A COG Study for Collecting and Banking Ewing Sarcoma Specimens

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00006799

NCT Number: NCT00899990

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AOST06B1 COG Protocol for Collecting and Banking Osteosarcoma Specimens

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Infectious Diseases
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00006812

NCT Number: NCT00899275

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ANHL04B1 Rare and Cutaneous Non-Hodgkin Lymphoma Registry

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Infectious Diseases
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00000017

NCT Number: NCT01000753

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AGCT0132 A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Infectious Diseases
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00007282

NCT Number: NCT00053352

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AREN0533 Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumor

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Infectious Diseases
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00010187

NCT Number: NCT00379340

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.



Comparison of Thrombin Generation of Sickle Cell Patients in Micro Particle Rich and Micro Particle Poor Plasma Using Thrombin Generation Assay (TGA)  

Principal Investigator: Nirmish Shah, MD
Category: Pediatric Hematology-Oncology
Phase: N/A
Sponsor: PI Initiated

Purpose:
All ages: The purpose of this study is to evaluate the clotting process in sickle cell patients. The goal is to find if we can predict which sickle cell patients may be difficult to treat and may have complications during crisis.

IRB Number: Pro00010645

Contact:
For more information, please contact Nirmish Shah, MD at 919-684-3401.


Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Infectious Diseases
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00011404

NCT Number: NCT00557193

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AAML0431: The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years 

Principal Investigator: Susan Kreissman, MD
Phase:  Phase 3
Category: Pediatric Infectious Diseases
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00011434

NCT Number: NCT00369317

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


An Open Label, Expanded Access Protocol Using 131I – Metaiodobenzylguanidine(131I-MIBG) Therapy in Patients with Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma.   

Principal Investigator: Michael Armstrong, MD
Category: Pediatric Hematology-Oncology
Phase: N/A
Sponsor: PI Initiated

Purpose:
12 months old through adult: There is no current routine care for neuroblastoma, pheochromocytoma, or malignant paraganglioma that does not respond well enough to or comes back after the first treatment. Several new agents, such as 131I MIBG, are being investigated for experimental treatment of recurrent and refractory neuroblastoma, pheochromocytoma, or malignant paraganglioma.

IRB Number: Pro00012332

Contact:
For more information, please contact Michael Armstrong, MD at 919-684-3401.


ALTE05N1 Umbrella Long-Term Follow-Up Protocol A Groupwide Non-Therapeutic Study

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00014697

NCT Number: NCT01000753

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ABTR01B1: A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00014715

NCT Number: NCT00898079

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AALL05B1:  A Children's Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Reserach Specimens

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00016445

NCT Number: NCT00897325

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AEPI05N1 Carcinogen Metabolism, DNA Repair, Parental Exposure and Retinoblastoma

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00017316

NCT Number: NCT00690469

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AHOD04B1 Hodgkin Disease (HD) Banking Study

Principal Investigator: Susan Kreissman, MD
Phase:  N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00017316

NCT Number: NCT00352534

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ALTE03N1 Key Adverse Events after Childhood Cancer

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00017332

NCT Number: NCT00082745

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ARET0321 A Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00018640

NCT Number: NCT00554788

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AAML0631: Risk-adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox (R) IND #103,331) During Consolidation

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00018686

NCT Number: NCT00866918

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ACCL05C1: A Group-Wide PENDING Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy (A Group-wide Non-Therapeutic Study)

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00019381

NCT Number: NCT00458887

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


A Randomized Phase III Study of Sodium Thiosufate for the Prevntion of Cisplatin-Induced Ototoxicity in Children

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00021065

NCT Number: NCT00716976

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AHEP0731 Treatment of Children with All Stages of Hepatoblastoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00021079

NCT Number: NCT00980460

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ARAR0331 Treatment of Chidlhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradioatherapy

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00021685

NCT Number: NCT00274937

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AALL06N1: A Study of Neurocognitive Function in Children Treated for ALL

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00021704

NCT Number: NCT00437060

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


Treatment of Adrenocortical Tumors with Surgery plus Lymph Node Dissection and Multiagent Chemotherapy

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00022500

NCT Number: NCT00304070

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AREN0534 Treatment for Patients with Bilateral, Multicentric, or Bilaterally-Predisposed Unilateral Wilms Tumor

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00022580

NCT Number: NCT00945009

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ARST08P1 A Pilot Study to Evaluate Novel Agents (Temozolomide and Cixutumumab [IMC-A12, Anti-IGF-IR Monoclonal Antibody, IND #100947, NSC #742460]) in Combination with Intensive Multi-Agent Interval Compressed Therapy for Patients with High-Risk Rhabdomyosarcoma

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00024445

NCT Number: NCT01055314

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AALL08B1 Classification of Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00025867

NCT Number: NCT01142427

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AALL0932  Treatment of Patients with Newly Diagnosed Standard Risk B-Precursor Acute Lymphoblastic Leukemia (ALL)

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00025879

NCT Number: NCT01190930

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AAML08B1  Biology Study of Transient Myeloproliferative Disoder (TMD) in Children with Down Syndrome (DS)

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00026823

NCT Number: NCT00959283

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AGCT0521 Treatment of Recurrent or Resistand Pediatrici Malignant Germ Cell tumors with Paclitaxel, Ifosfamide and Carboplatin

Principal Investigator: Susan Kreissman, MD
Phase: Phase 2
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00026837

NCT Number: NCT00467051

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


Use of Voraxaze as Adjunctive Treatment for Patients Experienceing or at Risk of Methotrexate Toxicity IND#11557 (Proo016

Principal Investigator: Susan Kreissman, MD
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Protherics

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00028682

NCT Number: NCT00481559

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AEWS1031 A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00028814

NCT Number: NCT01231906

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


NANT2007-02 A Phase I Study of Bevacizumab with Bolus and Metronomic Cyclophosphamide and Zoledronic Acid in Children with Recurrent or Refractory Neuroblastoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00028882

NCT Number: NCT00885326

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


NANT2007-03 Vorinostat with I-MIBG Therapy for Resistant/Relapsed Neuroblastoma: A Phase I Study IND#105744 New approaches to Neuroblastoma Therapy (NANT)

Principal Investigator: Susan Kreissman, MD
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00028894

NCT Number: NCT01019850

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


NANT2008-02 A Phase 1 Study of Vorinostat in Combination with 13-cis-retinoic acid in Patients with Refractory/Recurrent Neuroblastoma (IND#79176)

Principal Investigator: Susan Kreissman, MD
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00028996

NCT Number: NCT01208454

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


NANT 2004-03 A Phase I Study of Intravenous (Emulsion) Fenretinide (4-HPR, NSC 374551) in Children with Recurrent or Resistant Neuroblastoma (IND #70,058)

Principal Investigator: Susan Kreissman, MD
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00030624

NCT Number: NCT00646230

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


NANT 2004-04 Phase I Study of Fenretinide (4HPR, NSC 374551) Lym-X-Sorb (TM) (LXS) Oral Powder in Patients with Recurrent or Resistant Neuroblastoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: New Approaches to Neuroblastoma Therapy Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00030624

NCT Number: NCT00646230

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AAML1031 A Phase III Randomized Trial for Patients with de novo AML using Bortezomib (IND# 58443, NSC# 681239) and Sorafenib (BAY 43-9006, IND#69896, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00031615

NCT Number: NCT01371981

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ACCL0933 A Randomized Open-Label Trial of Caspofungin versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

Principal Investigator: Susan Kreissman, MD
Phase: Phase 3
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00033044

NCT Number: NCT01307579

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


AALL07P1 A Phase II Pilot Trial of Bortezomib (PS-341, Velcade, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Principal Investigator: Susan Kreissman, MD
Phase: Phase 2
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00033118

NCT Number: NCT00873093

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ARST0921 A Randomized Phase II Trial of Bevacizumab (IND# 7921, Avastin) and Temsirolimus (IND# 61010, Torisel) in Combination with Intravenous Vinorelbine and Cyclophosphamide in Patients with Recurrent/Refractory Rhabdomyosarcoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 2
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00033126

NCT Number: NCT01222715

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


ANBL1021 Feasibility/Phase II Study of hu14.18-IL2 immynocytokine + GM-CSF and Isotretinoin in Patinets with Relapsed or Refractory Neuroblastoma

Principal Investigator: Susan Kreissman, MD
Phase: Phase 2
Category: Pediatric Hematology-Oncology
Sponsor: Children's Oncology Group

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00034344

NCT Number: NCT01334515

Contact:
For more information, please contact Susan Kreissman, MD at 919-684-3401.


DNA/RN Clinical Research CoordinatorA: NANT2004-05 Neuroblastoma Biology Study

Principal Investigator: Michael Armstrong, MD
Category: Pediatric Hematology-Oncology
Phase: N/A
Sponsor: PI Initiated

Purpose:
31 days old through adult: This is a study to collect and do research on normal cells and/or tumor cells in the laboratory. Learning more about patients whose neuroblastoma tumors may help doctors to develop better therapies for neuroblastoma.

IRB Number: Pro00031917

Contact:
For more information, please contact Michael Armstrong, MD at 919-684-3401.


Brain Tumor

PBTC-026: A Feasibility Study of SAHA Combined with Isotretinoin and Chemotherapy in Infants with Embryonal Tumors of the Central Nervous System

Principal Investigator: Sri Gururangan, MD

Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00016235

NCT Number: NCT00867178

Contact:
For more information, please contact Jennifer King, RN, Clinical Trials Coordinator at 919-668-5364.


PBTC-033 A Phase I/II Study of ABT-888, an Oral Poly (ADP-ribose) Polymerase Inhibitor, and Concurrent Radiation Therapy, Followed by ABT-888 and Temozolomide, in Children with Newly Diagnosed Diffuse Pontine Gliomas (DIPG)

Principal Investigator: Sri Gururangan, MD

Phase: Phase 1 and 2
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00035751

NCT Number: NCT01514201

Contact:
For more information, please contact Jennifer King, RN, Clinical Trials Coordinator at 919-668-5364.


PBTC-025B: A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Adults with Recurrent or Refractory Medulloblastoma

Principal Investigator: Sri Gururangan, MRCP
Phase: Phase 2 
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00018492

NCT Number: NCT00939484

Contact:
For more information, please contact Jennifer King, RN, Clinical Research Coordinator, at 919-668-5364.


PBTC-029: Phase I and Pharmacokinetic Study of AZD6244 for Recurrent or Refractory Pediatric Low Grade Glioma

Principal Investigator: Sri Gururangan, MRCP
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00023836

NCT Number: NCT01089101

Contact:
For more information, please contact Jennifer King, RN, Clinical Research Coordinator at 919-668-5364.


PBTC-N11: Immunologic Profile of Patients with Newly Diagnosed Medulloblastoma at Initial Diagnosis and During Standard Radiation and Chemotherapy

Principal Investigator: Sri Gururangan, MRCP
Phase: N/A
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00024370

NCT Number: NCT01233479

Contact:
For more information, please contact Jennifer King, RN, Clinical Research Coordinator at 919-668-5364.


PBTC-031: Phase I and Pharmacokinetic Trial of PTC299 in Pediatric Patients with Refractory or Recurrent CNS Tumor

Principal Investigator: Sri Gururangan, MRCP
Phase: Phase 1
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00025750

NCT Number: NCT01158300

Contact:
For more information, please contact Jennifer King, RN, Clinical Research Coordinator at 919-668-5364.


PBTC-032 - A Phase II Clinical Trial Evaluating the Efficacy and Safety of GDC-0449 in Children with Recurrent or Refractory Medulloblastoma

Principal Investigator: Sri Gururangan, MRCP

Phase: Phase 2
Category: Pediatric Hematology-Oncology
Sponsor: Pediatric Brain Tumor Consortium

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00027660

NCT Number: NCT01239316

Contact:
For more information, please contact Jennifer King, RN, Clinical Research Coordinator at 919-668-5364.


Recurrent Medulloblastoma and Primitive Neuroectodermal Tumor Adoptive T Cell Therapy during Recovery from Myeloablative Chemotherapy and Hematopoietic Stem Cell Transplantation

Principal Investigator: Duane Mitchell, MD

Phase: Phase 1 and 2
Category: Pediatric Hematology-Oncology
Sponsor: Duke University

Purpose:
For detailed information, please view this trial at ClinicalTrials.gov.

IRB Number: Pro00018020

NCT Number: NCT01326104

Contact:
For more information, please contact Jennifer King, RN, Clinical Trials Coordinator at 919-668-5364.