A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
Conditions: Leukemia
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT03959085.
Stopping Tyrosine Kinase Inhibitors (TKI) to Assess Treatment-Free Remission (TFR) in Pediatric Chronic Myeloid Leukemia - Chronic Phase (CML-CP)
Conditions: Leukemia
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT03817398.
A Phase 3 Randomized Trial for Patients with De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 with GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients with FLT3 Mutations
Conditions: Leukemia
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT04293562.
An Open-Label Feasibility Study to Assess the Safety and Pharmacokinetics of Enasidenib in Pediatric Patients with Relapsed/Refractory Acute Myeloid Leukemia R/R-AML with an Isocitrate Dehydrogenase-2 IDH2 Mutation
Conditions: Leukemia
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT04203316.
Pediatric Acute Leukemia (PedAL) Screening Trial – Developing New Therapies for Relapsed Leukemias
Conditions: Leukemia
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT04726241.
A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG)
Conditions: Glioma
Principal Investigator: Maggie Fader
Learn more at https://pubmed.ncbi.nlm.nih.gov/34838156/.
A Phase 3 Randomized Study of Selumetinib (IND # 77782) versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)
Conditions: Glioma
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT03871257.
A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine versus Selumetinib (NSC# 748727, IND# 77782) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) not associated with BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)
Conditions: Glioma
Principal Investigator: Ziad Khatib
Learn more at https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCT04166409&r=1.
A Phase 3 Randomized, Placebo-Controlled Trial Evaluating Memantine (IND# 149832) for Neurocognitive Protection in Children Undergoing Cranial Radiotherapy as Part of Treatment for Primary Central Nervous System Tumors
Conditions: Central Nervous System Tumors
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT04939597.
A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
Conditions: Central Nervous System Tumors
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT04684368.
A Phase 3 Study of Sodium Thiosulfate for Reduction of Cisplatin-Induced Ototoxicity in Children with Average-Risk Medulloblastoma and Reduced Therapy in Children with Medulloblastoma with Low-Risk Features
Conditions: Medulloblastoma
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT05382338.
A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
Conditions: Sarcoma
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT05235165.
A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
Conditions: Sarcoma
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT05691478.
A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy with Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) plus VINO-CPO Maintenance in Patients with High Risk Rhabdomyosarcoma (HR-RMS)
Conditions: Sarcoma
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT04994132.
A Prospective Phase 3 Study of Patients with Newly Diagnosed Very Low-risk and Low-risk Fusion Negative Rhabdomyosarcoma
Conditions: Sarcoma
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT05304585.
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
Conditions: Germ Cell Tumor
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT03067181.
Phase 3 Accelerated BEP Trial: A Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients With Intermediate and Poor-Risk Metastatic Germ Cell Tumors
Conditions: Germ Cell Tumor
Principal Investigator: Maggie Fader
Learn more at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6114870/.
Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) – Phase 2/3
Conditions: Hepatic Malignancy
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT03017326.
A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma
Conditions: Hodgkin's Lymphoma
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT05675410.
Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
Conditions: Wilms Tumor
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT04322318.
Prospective Cohort Study to Evaluate Immunologic Response Following COVID-19 Vaccination in Children, Adolescents and Young Adults with Cancer
Conditions: Childhood Cancer
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT05228275.
Phase 2 Study of Tovorafenib (DAY101) in Relapsed and Refractory Langerhans Cell Histiocytosis
Conditions: Langerhans Cell Histiocytosis
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT05828069.
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients with Relapsed/ Refractory Aggressive Mature B-cell Neoplasms
Conditions: B-Cell Neioplasms
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT05206357.
Newly Diagnosed Children (<10 y/o) With Medulloblastoma and Other CNS Embryonal Tumors: Clinical and Molecular Risk-Tailored Intensive and Compressed Induction Chemotherapy Followed by Consolidation With Either Single Cycle (Low-Risk Patients) Or Randomization (High Risk Patients) To Either Single-Cycle Or To Three Tandem Cycles Of Marrow-Ablative Chemotherapy With Autologous Hematopoietic Progenitor Cell Rescue
Conditions: Medulloblastoma
Principal Investigator: Ziad Khatib
Learn more at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7237968/.
A Two-staged, Phase 2/3, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of REC-2282 in Participants With Progressive NF2 Mutated Meningiomas
Conditions: Meningioma
Principal Investigator: Ziad Khatib
CRA: Michelin Janvier
Learn more at https://clinicaltrials.gov/study/NCT05130866.
A Study Using Molecular Guided Therapy with Induction Chemotherapy followed by a Randomized Controlled Trial of standard immunotherapy with or without DFMO followed by DFMO maintenance for Subjects with Newly Diagnosed High-Risk Neuroblastoma
Conditions: Neuroblastoma
Principal Investigator: Guillermo De Angulo
Learn more at https://clinicaltrials.gov/study/NCT02559778.
OKlahoma Nitrone-007: novel treatment for diffuse intrinsic pontine glioma
Conditions: Diffuse Midline Glioma
Principal Investigator: Ossama Maher
Learn more at https://clinicaltrials.gov/study/NCT05518838.
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-101 (Larotrectinib) in Patients With Tumors Harboring Actionable NTRK Fusions
Conditions: Solid tumors, non-Hodgkin lymphoma, or histiocytic disorders
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT03213704.
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Ensartinib in Patients With Tumors Harboring ALK or ROS1 Genomic Alterations
Conditions: Solid tumors, non-Hodgkin lymphoma, or histiocytic disorders
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT03213652.
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of AG-120 (Ivosidenib) in Patients With Tumors Harboring IDH1 Mutations
Conditions: Solid tumors
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT04195555.
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Tipifarnib in Patients With Tumors Harboring HRAS Genomic Alterations
Conditions: Tumor with Genomic Alterations
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT04284774.
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-292 in Patients With Tumors Harboring RET Gene Alterations
Conditions: Solid tumors
Principal Investigator: Ziad Khatib
Learn more at https://clinicaltrials.gov/study/NCT04320888.
Key Adverse Events after Childhood Cancer
Principal Investigator: Maggie Fader
Learn more at https://www.clinicaltrials.gov/study/NCT00082745.
Treatment of Newly Diagnosed Diffuse Anaplastic Wilms Tumors (DAWT) and Relapsed Favorable Histology Wilms Tumors (FHWT)
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT04322318.
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
Conditions: Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders
Principal Investigator: Maggie Fader
CRA: Michelin Janvier
Learn more at https://www.clinicaltrials.gov/study/NCT03155620.
Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
Conditions: Sarcoma
Principal Investigator: Maggie Fader
Learn more at https://clinicaltrials.gov/study/NCT05235165.
Chemotherapy for the Treatment of Patients with Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
Conditions: Sarcoma
Principal Investigator: Maggie Fader
Learn more at https://www.cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01012&r=1.
NIH Ex-Vivo (FIU) Adopting a Functional Precision Medicine Approach to Reduce Cancer Disparities in Hispanic and Black Children of Miami
Conditions: Cancers
Principal Investigator: Maggie Fader
Learn more at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7138443/.
Prospective Non-Interventional Study in Patients with Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib
Conditions: Tumors
Cancer
Principal Investigator: Ossama Maher
Learn more at https://clinicaltrials.gov/study/NCT04142437.
Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to provide access for patients with out of specification leukapheresis product and/or out of specification manufactured tisagenlecleucel (CTL019; Kymriah®)
Conditions: Leukemia
Principal Investigator: Guillermo De Angulo
Learn more at https://clinicaltrials.gov/study/NCT03601442.
Ex Vivo Drug Sensitivity Testing and Mutation Profiling
Conditions: Tumors
Principal Investigator: Maggie Fader
Learn more at https://classic.clinicaltrials.gov/ct2/show/NCT03860376.