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  • LCH-IV International Collaborative Treatment Protocol for Children and Adolescents with Langerhans Cell Histiocytosis

    Principal Investigator:

    Justine Kahn, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT02205762

    Population:

    Pediatrics

    Phase:

    II/III
    The LCH-IV is an international, multicenter, prospective clinical study for pediatric Langerhans Cell Histiocytosis LCH (age < 18 years). LCH is a rare disease of the immune system that may affect any age group. It can affect many different organs, including the skeleton, skin, lymph nodes, liver, lungs, spleen, hematopoiesis, or central nervous system (CNS). There are two widely recognized disease extent categories: single-system LCH (involvement of a single organ or system) and multisystem LCH (involvement of 2 or more organ systems). Patients with SS-LCH of the skeleton, skin, or the...

  • A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma

    Principal Investigator:

    Nobuko Hijiya, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT04870944

    Population:

    Pediatrics/Adult

    Phase:

    I/II
    The purpose of this study is to find the highest dose of CBL0137 that can be given safely to patients with solid tumors that have come back (relapsed) or does not respond to treatment (refractory) solid tumors, including the CNS tumors and lymphoma. CBL0137 will be given into a vein on Day 1 and Day 8 of a 21 day cycle for up to 17 cycles, which will last about 24 months. Are you Eligible? (Inclusion Criteria) Inclusion Criteria: Part A: Patients must be at least 1 year of age and 21 years of age, have been diagnosed with relapsed or refractory relapsed or refractory solid tumors or lymphoma...

  • A Phase 1/2 Study of Tegavivint (IND#156033, NSC#826393) in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

    Principal Investigator:

    Nobuko Hijiya, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT04851119

    Population:

    Pediatrics/Adult

    Phase:

    I/II
    The purpose of this study is to find out what dose of tegavivint should be used with children and how well it works when given to patients between the ages of 12 months to 30 years of age with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of children with refractory or recurrent solid tumors, lymphomas, desmoid tumors, Ewing Sarcomas,...

  • A Phase I/II Study of Pembrolizumab (MK-3475) in Children with Advanced Melanoma or a PD-L1 Positive Advanced, Relapsed or Refractory Solid Tumor or Lymphoma (KEYNOTE-051)

    Principal Investigator:

    Nobuko Hijiya, MD

    Contact Number:

    212-342-5162

    NCT Number:

    NCT02332668

    Population:

    Pediatrics

    Phase:

    I/II
    This is a two-part study of pembrolizumab (MK-3475) in pediatric participants who have either advanced melanoma, relapsed or refractory classical Hodgkin lymphoma (rrcHL) or advanced, relapsed or refractory programmed cell death ligand 1 (PD-L1) positive malignant solid tumor or other lymphoma. Part 1 will find the maximum tolerated dose (MTD)/maximum administered dose (MAD), confirm the dose, and find the recommended Phase 2 dose (RP2D) for pembrolizumab therapy. Part 2 will further evaluate the safety and efficacy at the pediatric RP2D. This study is being sponsored by the Children's...