Hematology/Oncology Open Research Studies: Oncology

	UCSF Benioff Children's Hospital Oakland Hematology/Oncology Department Research Studies Open for Enrollment	Date: 01/26/2021

Oncology:

NEURO-ONCOLOGY
Title	ID/Protocol	NCT/Phase	Sponsor	P.I.	Contact
Oncology, Neuro-Onc
Phase 2 Study of Reduced Therapy for Newly Diagnosed Average-Risk WNT-Driven Medulloblastoma Patients	ACNS1422	NCT02724579 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Neuro-Onc, Solid Tumors
Clinical/Molecular Risk-Tailored Intensive, Compressed Induction Chemotherapy Followed by Consolidation Randomization To Single-Cycle or 3 Tandem Cycles of Marrow-Ablative Chemo with Hematopoietic Progenitor Cell Rescue	Head-Start-4	NCT02875314 Phase 4	Next Consortium, Nationwide Children's	Caroline Hastings, MD	Effie Bourgin
ONCOLOGY

Pediatric Tissue Bank at the Children's Hospital & Research Center Oakland	ONC Tissue Bank	N/A		Jon Rowland, MD
The Effectiveness of Lactobacillus plantarum (LBP, IND# 17339) in Preventing Acute Graft-versus-Host Disease (GvHD) in Children undergoing Alternative Progenitor Cell Transplantation	ACCL1633	NCT03057054 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology
Key Adverse Events after Childhood Cancer	ALTE03N1	NCT00082745 N/A	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Neuropsychological, Social, Emotional and Behavioral Outcomes in Children with Cancer	ALTE07C1	NCT00772200 N/A	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program	DCP-001	N/A N/A	NCORP	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Leukemia
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	AALL1931	NCT04145531 Phase 2/3	COG/GJazz Pharmaceuticals	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Ph+ ALL Testing Imatinib in Combination with Two Different Cytotoxic Chemotherapy Backbones	AALL1631	NCT03007147 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Phase 3 Trail of IND# 117467 (Blinatumomab) in Combination with Chemotherapy in Patients with Newly Diagnosed Stanrd Risk/Down Syndrome B-ALL and Localized B-Lly	AALL1731	NCT03914625 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Risk-stratified Therapy for Acute Myeloid Leukemia in Down Syndrome	AAML1531	NCT02521493 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Leukemia, Lymphoma, Solid Tumors
A Randomized Web-based Physical Activity Intervention among Children and Adolescents with Cancer	ALTE1631	NCT03223753 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Neuro-Onc
A Phase 2 Study of Veliparib (ABT-888, IND # 139199) and Local Irradiation, Followed by Maintenance Veliparib and Temozolomide, in Patients with Newly Diagnosed High-Grade Glioma (HGG) without H3 K27M or BRAFV600 Mutations	ACNS1721	NCT03581292 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Neuro-Onc, Leukemia, Lymphoma, Solid Tumors
Establishing Continuous Cell Lines and xenografts from Pediatric Cancers for Biological and Pre-Clinical Therapeutic Studies	ABTR04B1	NCT00898755	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Project:EveryChild A Registry, Eligibility Screening, Biology and Outcome Study	APEC14B1	NCT02402244 N/A	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Oncology: Early Phase, Lymphoma, Solid Tumors
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol	APEC1621SC	NCT03155620 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Oncology: Early Phase, Solid Tumors
Master NCI COG Pediatric MATCH (Molecular Analysis for Therapy Choice)	APEC1621	N/A Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Solid Tumors
Effects of Modern Chemotherapy Regimens on Spermatogenesis and Steroidogenesis in Adolescent and Young Adult Osteosarcoma Survivors	ALTE16C1	NCT03206450 N/A	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
LEAHRN (Late Effects After High-Risk Neuroblastoma) Study	ALTE15N2	NCT03057626 N/A	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Neuroblastoma Classification Biology Studies	ANBL00B1	NCT00904241	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)	AHEP1531	NCT03533582 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
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	AGCT1531	NCT03067181 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alt. w. Vincristine/Irinotecan (VI) Vs VAC/VI Plus Temsirolimus in Patients with Intermediate Risk Rhabdomyosarcoma	ARST1431	NCT02567435 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Renal Tumors Classification, Biology, and Banking Study	AREN03B2	NCT00945009 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Utilizing Response- and Biology-Based Risk Factors to Guide Therapy in Patients with Non-High-Risk Neuroblastoma	ANBL1232	NCT02176967 Phase 3	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
ONCOLOGY: EARLY PHASE

A Study Using Molecular Guided Therapy with Induction Chemotherapy followed by a Randomized Controlled Trial of standard Immunotherapy with or w/o DFMO followed by DFMO maintenance for Newly Diagnosed High-Risk Neuroblastoma	NMTRC012	NCT02559778 Phase 2	Beat Childhood Cancer (BCC)	Anu Agrawal, MD	Jennifer Michlitsch, MD
Leukemia, Lymphoma
Pilot Study of Mitoxantrone in combination with Clofarabine in Children, Adolescents and Young Adults with Refractory/Relapsed Acute Leukemia or High Grade Non-Hodgkin Lymphoma	MITCL	NCT01842672 Phase 1/2a	New York Medical College	Jennifer Michlitsch, MD	Jennifer Michlitsch, MD
Lymphoma, Solid Tumors
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of tazemetostat for patients with tumors harboring alterations in EZH2 or members of the SWI/SNF complex	APEC1621C	NCT03213665 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Neuro-Onc, Oncology: Early Phase, Lymphoma, Solid Tumors
NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE) - PHASE 2 SUBPROTOCOL OF AG-120 (IVOSIDENIB) IN PATIENTS WITH TUMORS HARBORING IDH1 MUTATIONS	APEC1621K	NCT04195555 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Oncology, Oncology: Early Phase
Open-Label, Multicenter, Phase 2 Study Evaluating Efficacy and Safety of Daratumumab in Ped and Young Adults >=1 and =<30 Years with Relapsed/Refractory Precursor B-cell or T-cell ALL	Daratumumab	Anu Agrawal, MD (510-428-3885 x3539)
Oncology, Oncology: Early Phase, Lymphoma, Solid Tumors
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of BVD-523FB (ulixertinib) in Patients with Tumors Harboring Activating MAPK Pathway Mutations	APEC1621J	NCT03698994 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of JNJ-42756493 (Erdafitinib) in patients with tumors harboring FGFR1/2/3/4 alterations	APEC1621B	NCT03210714 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LOXO-101 (larotrectinib) in patients with tumors harboring actionable NTRK fusions	APEC1621A	NCT03213704 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of LY3023414 in Solid Tumors	APEC1621D	NCT03155620 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of Palbociclib in Patients with Tumors Harboring Activating Alterations in Cell Cycle Genes	APEC1621I	NCT03526250 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of olaparib in patients with tumors harboring defects in DNA damage repair genes	APEC1621H	NCT03233204 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 subprotocol of Vemurafenib in patients with tumors harboring actionable BRAF V600 mutations	APEC1621G	NCT03220035 Phase 2	COG	Carla Golden, MD	Sheila Contapay-Tabilin, BSN, RN (510-428-3885 x 2611)<
Solid Tumors
Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine	NMTRC-014	NCT02679144 Phase 2	Beat Childhood Cancer (BCC)	Anu Agrawal, MD	Anu Agrawal, MD (510-428-3885 x3539)
Two-Part Study of TB-403 in Pediatric Subjects with Relapsed or Refractory Medulloblastoma, Neuroblastoma, Ewing Sarcoma or Alveolar Rhabdomyosarcoma	TB-403	NCT02748135 Phase 1/2a	Beat Childhood Cancer (BCC) and Oncurious NV	Jennifer Michlitsch, MD	Jennifer Michlitsch, MD (510-428-3885 x3264)
STEM CELL TRANSP AND CELLULAR THERAPY
Oncology
Role of KIR-favorably Mismatched Haploidentical Transplantation and KIR-polymorphisms in Determining Outcomes of Children with ALL/AML/MDS Undergoing Allogeneic Hematopoietic Cell Transplantation	ONC1401	NCT02646839 Phase 1/2	Pediatric Blood and Marrow Transplatn Consortium	Nahal Rose Lalefar, MD	Marci Moriarty, RN (510-428-3385 x5396)
Oncology: Early Phase, Leukemia
Pediatric and Young Adult Leukemia Adoptive Therapy. A Phase 1/2 Feasibility and Safety Study of CD19-CAR T Cell Immunotherapy for CD19+ Leukemia	PLAT-02	NCT02028455 Phase 1/2	Seattle Children's Hospital	Anu Agrawal, MD	Marci Moriarty, RN (510-428-3385 x5396)

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