Research Projects & Grants

• Expanded Access IND for Treatment Use with Trametinib for Treatment of a Pediatric Patient with Neurocutaneous Melanosis., Role: PI, Status: Approved

College/University

• POEM: A PrOspective Registry of Pediatric Cellular Therapy Patients at risk for Endothelial Dysfunction, Sinusoidal Obstruction Syndrome and/or Multi-Organ Dysfunction Syndrome (MODS), Role: Investigator, Duke University, (12/2023 - 12/2024) Status: Approved
• University of Alabama at Birmingham: National Registry of Pediatric Cancer Patients Diagnosed with COVID-19, Role: Investigator, University of Alabama at Birmingham, (06/2020) Status: Approved

Federal

• COG- AHOD0831: A non-randomized phase III study of response adapted therapy for the treatment of children with newly diagnosed high risk Hodgkin's Lymphoma, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• Children's Oncology Group (COG) - 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), Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• Children’s Oncology Group (COG) protocol AOST06B1 – collecting and banking osteosarcoma specimens, Role: Investigator, Children Oncology Group, (05/2023 - 05/2024) Status: Completed
• COG-ACNS0332: A study evaluating the efficacy of carboplatin administered concomitantly with radiation and isotretinoin as a pro-apoptotic agent in other than average risk medulloblastoma/PNET patients, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG – ARST0332: Risk-Based Treatment for Non-Rhabdomyosarcoma Sort Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age, Role: Investigator, Children Oncology Group, (03/2023 - 02/2024) Status: Completed
• COG: AREN0533 - Treatment of newly diagnosed higher risk favorable histology Wilms tumors, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG: 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 or T-Cell Lymphoblastic Lymphoma, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG: ARST 0531 - Randomized study of vincristine, dactinomycin and cyclophosphamide (VAC) versus VAC alternating with vincristine and ironotecan (VI) for patients with intermediate-risk rhabdomyosarcoma (RMS), Role: Investigator, Children Oncology Group, (04/2022 - 04/2023) Status: Completed
• COG # AREN0532 - Treatment for very low, low and standard risk favorable histology Wilms tumor, Role: Investigator, Children Oncology Group, (05/2013) Status: Completed
• COG- AREN03B2 - renal tumors classification, biology and banking study, Role: Investigator, Children Oncology Group, (07/2023 - 07/2024) Status: Approved
• COG - AOST0331, A randomized trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histologic response to pre-operative chemotherapy (EURAMOS 1), Role: Investigator, Children Oncology Group, (07/2011 - 07/2012) Status: Completed
• COG-ARST0331,Vincristine, dactinomycin, and lower doses of cyclophosphamide with or without radiation therapy for patients with newly diagnosed low-risk embryonal/botryoid rhabdomyosarcoma, Role: Investigator, Children Oncology Group, (06/2011 - 06/2012) Status: Completed
• COG-ANBLOOP3 - A Phase II/III study of the use of intravenous gammaglobulin therapy for patients with neuroblastoma associated opsoclonus-myoclonus-ataxia syndrome, Role: Investigator, Children Oncology Group, (04/2022 - 04/2023) Status: Completed
• COG-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, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG - ANBL0032 - Phase III randomized study of Chimeric antibody 14.18 (Ch14.18) in high risk Neuroblastoma following Myeloablative Therapy and autologous stem cell rescue, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG AAML 1921 / ITCC-054: A Phase I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia, Role: Investigator, Children Oncology Group, (08/2023 - 08/2024) Status: Approved
• COG AALL1631: International phase 3 trial in Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) testing imatinib in combination with two different cytotoxic chemotherapy backbones, Role: Investigator, Children Oncology Group, (07/2023 - 07/2024) Status: Approved
• COG ACNS1422: A Phase 2 Study of reduced therapy for newly diagnosed average-risk WNT-driven medulloblastoma patients, Role: Investigator, Children Oncology Group, (07/2023 - 07/2024) Status: Approved
• COG AALL1621: phase 2 study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in children and young adults with relapsed or refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL), Role: Investigator, Children Oncology Group, (07/2023 - 07/2024) Status: Approved
• COG AGCT1531: A phase 3 study of active surveillance for low risk and a randomized trial of carboplatin vs. cisplatin for standard risk pediatric and adult patients with germ cell tumors, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG ARST1431: A randomized phase 3 study of vincristine, dactinomycin, cyclophosphamide (VAC) alternating with vincristine and irinotecan (VI) versus VAC/VI plus temsirolimus (TORI, Torisel, NSC# 683864, IND# 122782) in patients with intermediate risk (IR) rhabdomyosarcoma (RMS), Role: Investigator, Children Oncology Group, (05/2023 - 05/2024) Status: Approved
• COG AOST1421: A phase 2 study of human-mouse chimeric anti-disialoganglioside monoclonal antibody ch14.18 (Dinutuximab, NSC #764038, IND #4308) in combination with sargramostim (GM-CSF) in patients with recurrent osteosarcoma, Role: Investigator, Children Oncology Group, (03/2023 - 03/2024) Status: Completed
• COG AAML1531: Risk-stratified therapy for acute myeloid leukemia in Down Syndrome, Role: Investigator, Children Oncology Group, (10/2023 - 10/2024) Status: Approved
• COG A031102: a randomized phase III trial comparing conventional-dose chemotherapy using paclitaxel, ifosfamide, and cisplatin (TIP) with high-dose chemotherapy using mobilizing paclitaxel plus Ifosfamide followed by high-dose carboplatin and etoposide (TI-CE) as first salvage treatment in relapsed or refractory germ cell tumors, Role: Investigator, Children Oncology Group, (09/2023 - 09/2024) Status: Approved
• COG-APEC14B1: project: EveryChild - a registry, eligibility screening, biology and outcome study, Role: Investigator, Children Oncology Group, (09/2023 - 09/2024) Status: Approved
• COG AAML1331: A phase III study for patients with newly diagnosed acute promyelocytic Leukemia (APL) using arsenic trioxide and all trans-retinoic acid, Role: Investigator, Children Oncology Group, (03/2024 - 03/2025) Status: Approved
• COG ACCL 1333 / BMS CV185-155: a phase III randomized, open label, multi-center study of the safety and efficacy of apixaban for thromboembolism prevention versus no systemic anticoagulant prophylaxis during induction chemotherapy in children with newly diagnosed acute lymphoblastic leukemia (ALL) or lymphoma (T or B cell) treated with Pegylated (PEG) L-asparaginase, Role: Investigator, Children Oncology Group, (10/2021 - 10/2022) Status: Completed
• COG AHOD 1331: randomized phase III study of Brentuximab Vedotin (SGN-35, IND #117117) for newly diagnosed high-risk classical Hodgkin Lymphoma (cHL) in children and adolescents, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG AEWS1221: Randomized phase 3 trial evaluating the addition of the IGF-1R monoclonal antibody ganitumab (AMG 479, NSC# 120449) to multiagent chemotherapy for patients with newly diagnosed metastatic Ewing sarcoma, Role: Investigator, Children Oncology Group, (03/2024 - 03/2025) Status: Approved
• Children's Oncology Group (COG) AALL1331: Risk-stratified randomized phase III testing of blinatumomab (IND#117467, NSC#765986) in first relapse of childhood B-Lymphoblastic Leukemia (B-ALL), Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG AALL1231: A phase III randomized trial investigating Bortezomib (NSC#681239; IND#58443) on a modified augmented BFM (ABFM) backbone in newly diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy), Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG-ANBL 1232:Utilizing response and biology based risk factors to guide therapy in patients with non-high risk neuroblastoma, Role: Investigator, Children Oncology Group, (05/2023 - 05/2024) Status: Approved
• COG - ANHL12P1: A randomized phase 2 trial of Brentuximab Vedotin or Crizotinib in combination with chemotherapy for newly diagnosed patients with anaplastic large cell lymphoma (ALCL), Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• TSLP and pediatric leukemia mechanisms and treatment, Role: Investigator, National Cancer Institute/NIH/DHHS, (07/2023 - 07/2024) Status: Approved
• COG-AREN0534: Treatment for patients with bilateral, multicentric, or bilaterally-predisposed unilateral Wilms tumor, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B- Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND #73789, NSC #732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG-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, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG-AAML0631:Risk adapted treatment of newly diagnosed childhood Acute Promyelocytic leukemia (APL) using Arsenic Trioxide (Trisenox, IND#103,331) during consolidation, Role: Investigator, Children Oncology Group, (01/2015 - 01/2016) Status: Completed
• Children's Oncology Group (COG) - AEWS1031: A phase III randomized trial of adding vincristine-topotecan-cyclophosphamide to standard chemotherapy in initial treatment of non-metastatic Ewing sarcoma, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• Children's Oncology Group (COG) - ACNS0831: Phase III randomized trial of post-radiation chemotherapy in patients with newly diagnosed ependymoma ages 1 to 21 years, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• Children's Oncology Group (COG)-AALL0932: Treatment of patients with newly diagnosed standard risk B-precursor acute lymphoblastic leukemia (ALL) or localized B-lineage lymphoblastic lymphoma (B-LLy), Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• Children's Oncology Group (COG) - ALTE05N1: Umbrella long-term follow-up protocol, Role: Investigator, Children Oncology Group, (12/2023 - 12/2024) Status: Approved
• COG - ACNS0334: A phase III randomized trial for the treatment of newly diagnosed supratentorial PNET and high risk medulloblastoma in children < 36 months old with intensive induction chemotherapy with methotrexate followed by consolidation with stem cell rescue vs. the same therapy without methotrexate, Role: Investigator, Children Oncology Group, (02/2024 - 02/2025) Status: Approved
• COG-ANBL00B1 Neuroblastoma biology studies Revised 11/30/2000, Role: Investigator, Children Oncology Group, (05/2023 - 05/2024) Status: Approved

For Profit Organization

• Jazz Pharmaceuticals JZP458-201 (COG AALL1931): An open-label, multicenter study of RC-P in patients with acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL) following hypersensitivity to E. coli-derived asparaginases, Role: Investigator, Jazz Pharmaceuticals, (01/2022 - 01/2023) Status: Completed
• COG ADVL1822/ Daiichi Sankyo, Inc. AC220-A-U202: A Phase 1/2, Multicenter, Dose-Escalating study to evaluate the safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Quizartinib administration in combination with re-induction chemotherapy, and as a single-agent continuation therapy, in pediatric relapsed/refractory AML subjects ages 1 month to <18 years (and Young adults ages up to 21 years) with FLT3-ITB mutations, Role: Investigator, Daiichi Sankyo Pharma Development, (07/2023 - 07/2024) Status: Approved

Foreign

• Pediatric blood and marrow transplant consortium (PBMTC) and Canadian Institutes of Health Research (CIHR) - GVHD-1202: Predictive biomarkers for pediatric chronic graft-versus-host disease, Role: Investigator, Canadian Institutes of Health Research, (09/2023 - 09/2024) Status: Approved

Internal

• LLU Cancer Center biospecimen laboratory - specimens collection protocol, Role: Investigator, LLU Cancer Institute, (09/2023 - 09/2024) Status: Approved

Non-Profit Organization

• PTCTC ONC1701 (End RAD): A phase II pilot trial to estimate survival after a non-total body irradiation (TBI) based on conditioning regimen in patients diagnosed with B-acute lymphoblastic leukemia (ALL) who are pre-allogeneic hematopoietic cell transplantation (HCT) next-generation-sequence (NGS) minimal residual disease (MRD) negative, Role: Investigator, Pediatric Blood and Marrow Transplant Consortium, (07/2023 - 07/2024) Status: Approved