CURRENTLY ENROLLING ONCOLOGY TREATMENT STUDIES (as of 4/27/2017) Leukemia AALL0932 closed after Induction Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy) AALL1131 A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum 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) AALL1331 Risk-Stratified Randomized Phase III Testing of Blinatumomab (IND#117467, NSC#765986) in First Relapse of Childhood B- Lymphoblastic Leukemia AAML1031 A Phase III Randomized Trial for Patients with de novo AML using Bortezomib and Sorafenib (IND#114480; NSC# 681239, NSC# 724772) for Patients with High Allelic Ratio FLT3/ITD FLT3 Negative withdraws after induction AAML1331 A Phase III Study for Patients with Newly Diagnosed Acute Promyelocytic Leukemia (APL) using Arsenic Trioxide and All-Trans Retinoic Acid AAML1522 A Phase II, Multi-Center, Single-Arm, Open-Label Study to Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomide (Revlimid) in Pediatric Subjects From 1 to 18 Years of Age with Relapsed or Refractory Acute Myeloid Leukemia AALL1521 POETIC 16-01 POETIC 14-01 A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitnib with Chemotherapy in Children with De Novo High-Risk CRLF2-Rearranged and/or Pathway-Mutant Acute Lymphoblastic Leukemia A Phase I/II Study of Neratinib in children and Pediatric Patients with Relapsed or Refractory Solid Tumors or Hematologic Malignancies Phase I Study of Carfilzomib in Combination with Cyclophosphamide and Etoposide for Children with Relapsed and Refractory Solid Tumors and Leukemias Page 1 of 6
Brain ACNS0332 ACNS0831 NMTRC 011 NMTRC ONC-403-001 POETIC G029665 POETIC 16-01 Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients (closed to PNET patients) Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years Molecular-Guided Therapy for the Treatment of Patients with Relapsed and Refractory Childhood Cancers Eligible Diagnoses: Medulloblastomas, Gliomas, Diffuse Intrinsic Pontine Glioma/DIPG/Diffuse Midline Tumor, Glioblastoma Multiforme, Ependymomas, Choroid Plexus Tumors, Craniopharyngiomas, Dysembryoplastic neuroepithelial tumors, Meningiomas, Primitive Neuroectodermal Tumors/CNS Embryonal Tumors, Germ Cell Tumors and Atypical Teratoid Rhabdoid Tumor A Phase I Trial of Tolcapone Alone and in Combination with Oxaliplatin in Patients with Relapsed or Refractory Neuroblastoma or Medulloblastoma A Two-Part Study of TB-403 in Pediatric Subjects with Relapsed or Refractory Medulloblastoma, Neuroblastoma, Ewing Sarcoma, or Alveolar Rhabdomyosarcoma A Phase I/II Multicenter, Open Label, Dose Escalation Study Of The Safety And Pharmacokinetics Of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors Eligible Diagnoses: Central Nervous System Gliomas (including high and low grade gliomas and DIPG), Atypical Teratoid/Rhabdoid Tumor (ATRT), and Schwannoma Young Adult Patients with Previously Treated Solid Tumors Eligible Diagoses: Atypical Teratoid/Rhabdoid Tumor (ATRT) only A Phase I/II Study of Neratinib in children and Pediatric Patients with Relapsed or Refractory Solid Tumors or Hematologic Malignancies Eligible Diagnoses: Any Central Nervous System Malignancy Liver AHEP0731 Treatment of Children with All Stages of Hepatoblastoma (observation/very low risk only) Long Term Effects ALTE11C2 Health Effects after Anthracycline and Radiation Therapy (HEART): Dexrazoxane and Prevention of Anthracycline-related Cardiomyopathy Page 2 of 6
Lymphoma AALL0932 AALL1231 AHOD1331 ALTE11C1 Treatment of Patients with Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy) 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) A Randomized Phase III Study of Brentuximab Vedotin (SGN-35, IND #117117) for Newly Diagnosed High-Risk Classical Hodgkin Lymphoma (chl) in Children and Adolescents Longitudinal Assessment of Ovarian Reserve in Adolescents with Lymphoma POETIC 16-01 currently closed for lymphoma patients C25004 A Phase I/II Study of Neratinib in children and Pediatric Patients with Relapsed or Refractory Solid Tumors or Hematologic Malignancies Young Adult Patients with Previously Treated Solid Tumors - Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma An Open-Label Study of Brentuximab Vedotin+Adriamycin, Vinblastine, and Dacarbazine in Pediatric Patients With Advanced Stage Newly Diagnosed Hodgkin Lymphoma Page 3 of 6
Neuroblastoma ANBL1232 Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma ANBL1221 A Phase II Randomized Trial of Irinotecan/Temozolomide with Temsirolimus (NSC# 683864, IND# 61010) or Chimeric 14.18 Antibody(ch14.18 (NSC# 764038, IND# 4308) in Children with Refractory, Relapsed or Progressive Neuroblastoma Molecular-Guided Therapy for the Treatment of Patients with Relapsed and Refractory Childhood Cancers NMTRC 010B NMTRC 012 NMTRC 014 NMTRC ONC-403-001 A Phase I/II Trial of DFMO in Combination with Bortezomib in Patients with Relapsed or Refractory Neuroblastoma A Pilot Study Using Molecular Guided Therapy with Induction Chemotherapy Followed by Maintenance with DFMO for Subjects with Newly Diagnosed High-Risk Neuroblastoma Neuroblastoma Maintenance Therapy Trial Using DFMO A Two-Part Study of TB-403 in Pediatric Subjects with Relapsed or Refractory Medulloblastoma, Neuroblastoma, Ewing Sarcoma, or Alveolar Rhabdomyosarcoma Renal Young Adult Patients with Previously Treated Solid Tumors - Wims Tumor Molecular-Guided Therapy for the Treatment of Patients with Relapsed and Refractory Childhood Cancers Eligible Diganoses: Wilms tumor, Renal Cell Carcinoma, Malignant Rhabdoid Tumor and Clear Cell Sarcoma Page 4 of 6
Sarcoma/Rhabdomyosaroma/Osteosarcoma/Ewing's Sarcoma AEWS1031 temporarily closed to accrual AEWS1221 AOST1321 A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-metastatic Ewing Sarcoma Randomized Phase II Trial Evaluating the Addition of the IGF-1R Monoclonal Antibody Ganitumab (AMG 479, NSC# 750008, IND# 120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma Phase II Study of Denosumab, a RANK Ligand Antibody, for Recurrent or Refractory Osteosarcoma AOST1421 temporarily closed to accrual ARST1321 CL PTL 121 temporarily closed to accrual NMTRC ONC-403-001 Phase II Study of Human-Mouse Chimeric Anti-Disialoganglioside Monoclonal Antibody ch14.18 in Combination with Sargramostim (GM-CSF) in Patients with Recurrent Osteosarcoma Pazopanib Neoadjuvant Trial In Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754, IND# 118613) Molecular-Guided Therapy for the Treatment of Patients with Relapsed and Refractory Childhood Cancers - Rhabdomyosarcoma and Non rhabdomyosarcoma, Ewings Sarcoma and Osteosarcoma A two-part Phase IIb Trial of Vigil (bi-shrna furin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Ewing s Sarcoma A Two-Part Study of TB-403 in Pediatric Subjects with Relapsed or Refractory Medulloblastoma, Neuroblastoma, Ewing Sarcoma, or Alveolar Rhabdomyosarcoma POETIC G029665 A Phase I/II Multicenter, Open Label, Dose Escalation Study Of The Safety And Pharmacokinetics Of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors Eligible Diagnoses: Embryonal Rhabdomyosarcoma, other Non-Rhabdomyosarcoma Soft Tissue Sarcomas, and Malignant Rhabdoid Tumors Young Adult Patients with Previously Treated Solid Tumors Eligible Diagnoses: Malignant Rhabdoid Tumor Page 5 of 6
Solid Tumors ADVL1322 A Phase II Trial of Pazopanib NSC# 737754, IND# 65747 in Children with Refractory Solid Tumors POETIC G029665 POETIC 14-01 Young Adult Patients with Previously Treated Solid Tumors Eligible Diagnoses: Malignant Rhabdoid Tumor A Phase I/II Multicenter, Open Label, Dose Escalation Study Of The Safety And Pharmacokinetics Of Cobimetinib In Pediatric And Young Adult Patients With Previously Treated Solid Tumors Phase I Study of Carfilzomib in Combination with Cyclophosphamide and Etoposide for Children with Relapsed and Refractory Solid Tumors and Leukemias Pending Studies (check on availability) ARST1431 Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS) AALL15P1 A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine to Chemotherapy in Infants with Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement Page 6 of 6