Clinical Trials Logo

Clinical Trial Summary

This phase I trial studies the side effects and best dose of selinexor in treating younger patients with solid tumors or central nervous system (CNS) tumors that have come back (recurrent) or do not respond to treatment (refractory). Drugs used in chemotherapy, such as selinexor, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the recommended phase 2 dose (RP2D) or the maximum tolerated dose (MTD) of the tablet formulation of selinexor in children with recurrent/refractory solid and CNS tumors. II. To describe the toxicities of selinexor in children with recurrent/refractory solid and CNS tumors. III. To characterize the pharmacokinetics of the tablet formulation of selinexor in children with recurrent/refractory solid and CNS tumors. SECONDARY OBJECTIVES: I. To determine the antitumor effect of selinexor in a preliminary manner in children with recurrent/refractory solid and CNS tumors. II. To determine the pharmacodynamic properties of selinexor in children and adolescents with refractory solid tumors in plasma proteins and whole blood ribonucleic acid (RNA). III. To explore the penetration, pharmacodynamic effects, and biologic effects of selinexor in tumor tissue of patients with recurrent/refractory high-grade gliomas (HGG) requiring resection. IV. To further assess the toxicity and antitumor effects of selinexor in children with recurrent/refractory HGG in expanded cohorts following dose-escalation by measuring rate of objective radiographic response (medical patients) and rate of progression-free survival (PFS) six months from the start of treatment (surgical patients). OUTLINE: This is a dose escalation study. Patients receive selinexor PO on either a twice weekly (days 1, 3, 8, 10, 15, 17) or once weekly (days 1, 8, 15, and 22) schedule. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02323880
Study type Interventional
Source Children's Oncology Group
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 30, 2015
Completion date September 22, 2024

See also
  Status Clinical Trial Phase
Terminated NCT02764151 - First in Patient Study for PF-06840003 in Malignant Gliomas Phase 1
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Completed NCT00953121 - Bevacizumab Plus Irinotecan Plus Carboplatin for Recurrent Malignant Glioma (MG) Phase 2
Completed NCT00766467 - A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Phase 2
Active, not recruiting NCT03233204 - Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Phase 2
Recruiting NCT05045027 - Simultaneous Multinuclear Metabolic MRI in Newly Diagnosed or Recurrent Glioma Early Phase 1
Completed NCT02507583 - Antisense102: Pilot Immunotherapy for Newly Diagnosed Malignant Glioma Phase 1
Completed NCT04109209 - Psychological Intervention For Brain Tumor Caregivers N/A
Recruiting NCT04937413 - The PCSK9i Inhibitor Evolocumab - a Surgical Trial of Pharamcodynamics and Kinetics Evaluation Early Phase 1
Completed NCT03615404 - Cytomegalovirus (CMV) RNA-Pulsed Dendritic Cells for Pediatric Patients and Young Adults With WHO Grade IV Glioma, Recurrent Malignant Glioma, or Recurrent Medulloblastoma Phase 1
Active, not recruiting NCT04175301 - Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas. Phase 2
Terminated NCT02659800 - Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas Phase 1
Completed NCT00782756 - Bevacizumab, Temozolomide and Hypofractionated Radiotherapy for Patients With Newly Diagnosed Malignant Glioma Phase 2
Terminated NCT02855086 - Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery Phase 1/Phase 2
Completed NCT00634231 - A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors Phase 1
Completed NCT02861222 - Myocet® in Children With Relapsed or Refractory Non-brainstem Malignant Glioma Phase 1
Completed NCT01792505 - Dendritic Cell Vaccine With Imiquimod for Patients With Malignant Glioma Phase 1
Completed NCT00190723 - A Study of LY317615 in Patients With Brain Tumors Phase 2
Recruiting NCT04323046 - Immunotherapy Before and After Surgery for Treatment of Recurrent or Progressive High Grade Glioma in Children and Young Adults Phase 1
Active, not recruiting NCT03893903 - AMPLIFYing NEOepitope-specific VACcine Responses in Progressive Diffuse Glioma Phase 1