Pauline Allen Gill Center for Cancer and Blood Disorders: Clinical Trials

For more information on open clinical trials

Jacob Thurman, CCRP
Oncology, Stem Cell Transplant
Clinical Research Manager
214-456-8138
wthurm@childrens.com

Leah Adix, CCRP
Hematology
Clinical Research Manager
214-456-2888
leah.adix@childrens.com

Open Clinical Trials

Acute Lymphocytic Leukemia

  • AALL02P2: Treatment of Late Isolated Extramedullary Relapse from Acute Lymphoblastic Leukemia
  • AALL0232: High Risk B-precursor Acute Lymphoblastic Leukemia
  • AALL03B1: Classification of Acute Lymphoblastic
  • AALL03N1: Understanding the Ethnic and Racial Differences in Survival in Children with Acute Lymphoblastic Leukemia
  • AALL0331: Standard Risk B-Precursor Acute Lymphoblastic Leukemia
  • ADVL04P2: A Feasibility Pilot and Phase 2 Study of Chemoimmunotherapy with Epratuzumab for Children with Relapsed CD22-Positive Acute Lymphoblastic Leukemia
  • ADVL0413: A Phase I Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (BAY 43-9006, NSC# 724772 IND# 69896) in Children with Refractory Solid Tumors or Refractory Leukemias
  • AALL0433: Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
  • 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 (ALL)
  • AALL05B1: A COG Protocol for Collecting and Banking Relapsed ALL Research Specimens
  • ADVL0516: A Phase 1 Study of BMS-354825 (Dasatinib) in Children with Recurrent/Refractory Solid Tumors or Imatinib Resistant Ph+ Leukemia
  • AALL0631: A Phase III Study of Risk Directed Therapy for Infants with Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND #76431; NSC #617807)
  • AALL06N1: A Study of Neurocognitive Function in Children Treated for Acute Lymphoblastic Leukemia (ALL)
  • Evaluation of the Influence of Pre-Diabetes on the Risk of Infection in Children with ALL and Lymphoblastic Lymphoma

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Acute Myelogenic Leukemia

  • AAML0431: Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Under the Age of 4 Years
  • AAML0531: A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg®) Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
  • AAML0523: A Phase I/II Study of CLOLAR (Clofarabine IND# 73,789) in Combination with Cytarabine in Pediatric Patients with Refractory/Relapsed Leukemia
  • AAML06P1: A Pilot Study of Lestaurtinib (CEP-701) in Combination with Chemotherapy in Young Patients with Relapsed or Refractory FLT3-mutant Acute Myeloid Leukemia

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Brain Tumor

  • A Pharmacokinetic and Phase II Study of Oral Cyclophosphamide and Oral Topotecan in Children with Recurrent and/or Refractory Solid Tumors
  • ONC-032P: High Dose Temozolomide, Thiotepa and Carboplatin with ASCR Followed by Continuation Therapy with 13-Cis-Retinoic Acid for Recurrent/Refractory Malignant Brain Tumors
  • ACNS0122: A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery To Eliminate All Measurable Disease Prior to Radiotherapy For NGGCT
  • ACNS0221: A Phase II Study of Conformal Radiotherapy in Patients with Low Grade Gliomas
  • ACNS0232: Radiotherapy Alone Versus Chemotherapy Followed by Response-Based Radiotherapy for Newly Diagnosed Primary CNS Germinoma
  • ACNS0331: A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy 18.00 Gy and Chemotherapy In Children with Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial
  • ACNS0332: Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients
  • ADVL0515: A Phase I Study of Vinblastine in Combination with Carboplatin for Children with Newly Diagnosed and Recurrent Low-Grade Gliomas

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Ewing's Sarcoma

  • AEWS0331: European Ewing Tumor Working Initiative of National Groups Ewing Tumour Studies 1999 (EURO-E.W.I.N.G.99)
  • AEWS02B1: A Groupwide Biology and Banking Study for Ewing Sarcoma
  • AEWS0521: A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND# 7921) Combined with Vincristine, Topotecan and Cyclophosphamide in Patients with First Recurrent Ewing Sarcoma
  • A Phase 1/Phase 2 Study of CP-751,871 in Patients with Relapsed and/or Refractory Ewing's Sarcoma Family of Tumors

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Germ Cell Tumor

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

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Liver Tumors

  • 9346: Hepatoblastoma Biology Study and Tissue Bank
  • AEPI04C1: Low Birth Weight and Other Risk Factors for Hepatoblastoma

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Hodgkin Disease

  • AHOD0031: A Phase III Study of Dose-Intensive, Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease
  • AHOD03P1: Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)
  • AHOD0431: Phase III Study for the Treatment of Children and Adolescents with Newly Diagnosed Low-Risk Hodgkin Disease
  • AHOD0521: A Phase II Study of Bortezomib (Velcade, PS-341, IND # 58443) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Refractory/Recurrent Hodgkin Disease

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Neuroblastoma

  • ANBL00B1: Neuroblastoma Biology Studies
  • ANBL0032: Phase III Randomized Study of Chimeric Anti-GD2 in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue
  • ANBL0421: A Phase II Study of Irinotecan + Temozolomide in Children with Recurrent Neuroblastoma
  • ANBL0532: Phase III Randomized Trial of Single vs. Tandem Myeloablative as Consolidation Therapy for High-Risk Neuroblastoma
  • ANBL0621: A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children with Relapsed or Refractory Neuroblastoma

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Non-Hodgkin Lymphoma

  • 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
  • ANHL01P1: A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated with LMB/FAB Therapy
  • ANHL06P1: A Phase I/II Pilot Study of Ifosfamide, Carboplatin and Etoposide Therapy (ICE) and SGN-30 (NSC #731636, IND #10057) in children with CD30+ Recurrent Anaplastic Large Cell Lymphoma

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Osteosarcoma

  • COG 9851: Osteosarcoma Biology Protocol: Companion to Group-Wide Therapeutic Studies
  • 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
  • AOST0221: A Phase II Study of Aerosolized GM-CSF (NSC# 613795, IND # 11042) in Osteosarcoma Patients with First Pulmonary Recurrence of Osteosarcoma

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Oncology Late Effects/Cancer Control

  • 9442: National Wilms Tumor Late Effects Study
  • ALTE03N1: Key Adverse Events after Childhood Cancer
  • ALTE04N1: Health-Related Outcomes for Hodgkin Disease Survivors
  • ACCL05C1: A Group-Wide, Prospective Study of Ototoxicity Assessment in Children Receiving Cisplatin Chemotherapy
  • Childhood Cancer Survivor Study Expansion: Long Term Follow-Up Study

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Rare Tumors

  • ARAR0331: Treatment of Childhood Nasopharyngeal Carcinoma with Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy

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Soft Tissue Sarcoma, including Rhabdomyosarcoma

  • 9902: Soft Tissue Sarcoma Biology and Banking Protocol
  • ARST0321: A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy
  • 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
  • ARST0531: Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

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Wilms/Kidney Tumors

  • AREN03B2: Renal Tumors Classification, Biology, and Banking Study
  • AREN0321: Treatment of High Risk Renal Tumors
  • AREN0532: Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms Tumor
  • AREN0533: Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

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Phase I Trial

  • Phase I Study of Topotecan/Temozolomide in the Treatment of Children and Adolescents with Refractory Solid Tumors
  • A Phase I/II Safety and Exploratory Pharmacodynamic Study of Intravenous Temsirolimus (CCI-779) in Pediatric Subjects with Relapsed/Refractory Solid Tumors
  • AAML0523: A Phase I/II Study of CLOLAR (Clofarabine IND# 73,789) in Combination with Cytarabine in Pediatric Patients with Refractory/Relapsed Leukemia
  • ADVL0413: A Phase I Study of the Raf Kinase and Receptor Tyrosine Kinase Inhibitor Sorafenib (BAY 43-9006, NSC# 724772 IND# 69896) in Children with Refractory Solid Tumors or Refractory Leukemias
  • ADVL0414: Phase I Trial of Temozolomide, Oral Irinotecan, and Vincristine for Children with Refractory Solid Tumors
  • ADVL0515: A Phase I Study of Vinblastine in Combination with Carboplatin for Children with Newly Diagnosed and Recurrent Low-Grade Gliomas
  • ADVL0516: A Phase 1 Study of BMS-354825 (Dasatinib) in Children with Recurrent/Refractory Solid Tumors or Imatinib Resistant Ph+ Leukemia
  • ADVL0612: A Phase I Study of Sunitinib (SU11248), an Oral Multi-Targeted Tyrosine Kinase Inhibitor, in Children with Refractory Solid Tumors
  • ADVL0712: A Phase I Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND# 100947, NSC# 742460) in Children with Relapsed/Refractory Solid Tumors
  • ADVL0714: A Phase I Trial of VEGF Trap (NSC# 724770, IND# 100137) in Children with Refractory Solid Tumors
  • ANHL06P1: A Phase I/II Pilot Study of Ifosfamide, Carboplatin and Etoposide Therapy (ICE) and SGN-30 (NSC #731636, IND #10057) in children with CD30+ Recurrent Anaplastic Large Cell Lymphoma

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Stem Cell Transplantation

  • National Marrow Donor Program (NMDP) Recipient Consent for Participation and Donation of Blood Samples
  • ONC032P: High Dose Temozolomide, Thiotepa and Carboplatin with ASCR Followed by Continuation Therapy with 13-Cis-Retinoic Acid for Recurrent/Refractory Malignant Brain Tumors
  • 0301: Fludarabine-based Conditioning for Allogeneic Marrow Transplantation from HLA-compatible Unrelated Donors in Severe Aplastic Anemia
  • 0501: Multi-center, Open Label, Randomized trial Comparing Single vs. Double Umbilical Cord Blood (UCB) Transplantation in Pediatric Patients with High Risk Leukemia and Myelodysplasia
  • ASCT0431: A Randomized Trial of Sirolimus-Based Graft versus Host Disease (GVHD) Prophylaxis after Hematopoietic Stem Cell Transplantation (HSCT) in Relapsed Acute Lymphoblastic Leukemia (ALL)
  • ASCT0521: Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute Non-Infectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation
  • ASCT0631: A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source in Matched Sibling Donor Transplantation
  • A Phase I Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects with Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
  • A Phase III, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety or Prochymal (Ex-vivo Cultured Adult Mesenchymal Stem Cells) Infusion for the Treatment of Steriod Refractory Acute GVHD

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Sickle Cell Disease

  • Sickle Cell Disease Registry and Long-Term Follow-up Project
  • Pediatric Hydroxyurea Phase III Clinical Trial: BABY HUG
  • Silent Infarct Transfusion Trial (SITT)
  • Randomized Trial of Intravenous Ketorolac Versus Oral Ibuprofen for Painful Crisis
  • Thalassemia Clinical Research Network - Longitudinal Cohort Study
  • Neuropsychological Dysfunction and Neuroimaging Abnormalities in Neurologically Intact Adult Patients with Sickle Cell Disease
  • Comprehensive Sickle Cell Centers Collaborative Data Project (C-DATA)
  • Randomized Trial of Oral Dexamethasone for Acute Chest Syndrome
  • SWiTCH: A Phase III randomized clnical trial to compare standard therapy (erythrocyte transfusions with iron chelation with alternative therapy (hydroxyurea with phlebotomy) for the prevention of secondary stroke
  • CHAMPS: Effectiveness of Hydroxyurea and Magnesium Piolate alone and in combination in Hemoglobin SC Disease: A Phase II Trial
  • Measurement of Myocardial Iron Content by Magnetic Resonance Imaging using the T2* Sequence
  • Acute Bone Turnover and Disordered Porphyrin Metabolism as Novel Potential Mechanisms of Sickle Cell Pain

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Hemostasis and Thrombosis

  • Pediatric Thrombophilia Registry
  • Fibrogammin P for Patient with Factor XIII Deficiency
  • Universal Data and Serum Specimen Collection Systems for Hemophilia
  • Use of Central Venous Catheters in Children with Hemophilia
  • Rituximab for Treatment of Inhibitor in Congenital Hemophilia A: The RICH Study
  • Thrombosis and Pulmonary Arterial Hypertension in Persons Following Splenectomy
  • Prospective Assessment of Risk Factors for Thrombosis in Persons with Hereditary Spherocytosis
  • Splenectomy at Parkland Health and Hospital System (PHHS)
  • Identification and Treatment of Clinically Silent Catheter-related Deep Vein Thrombosis in Children with Cancer (Diagnosis Study)

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Other Hematology 

  • BESTIRON clinical trial for young children with nutritional iron deficiency anemia
  • Severe Chronic Neutropenia International Registry
  • North American Registry of Chronic ITP in Children and Adolescents
  • Diamond Blackfan Anemia Registry
  • Splenectomy Registry: Prospective, multi-center International Study on Behalf of the Intercontinental Childhood Idiopathic Thrombocytopenic Purpura (ITP) Study Group
  • Retrospective Bleeding Assessment of Children with Idiopathic Thrombocytopenic Purpura
  • Hematopathologic Study of the Bone Marrow of Bone Marrow Failure Syndromes (Biology Study)
  • A Randomized, Double Blind, Placebo-controlled Phase I/ II Study to Determine the Safety and Efficacy of AMG 531 in Thrombocytopenic Pediatirc Subjects with Chronic Immune Thrombocytopenic Purpura
  • An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

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