A Phase 1/2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma
Children's Oncology Group
Summary
This phase I/II trial evaluates the best dose, side effects and possible benefit of CBL0137 in treating patients with solid tumors, including central nervous system (CNS) tumors or lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Drugs, such as CBL0137, block signals passed from one molecule to another inside a cell. Blocking these signals can affect many functions of the cell, including cell division and cell death, and may kill cancer cells.
Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of Facilitates Chromatin Transcription (FACT) complex-targeting curaxin CBL0137 (CBL0137) administered via infusion on Day 1 and Day 8 of a 21-day cycle to children with recurrent or refractory solid tumors, including CNS tumors and lymphoma. (Phase 1 Dose Escalation) II. To preliminarily determine the antitumor effects as measured by objective response rate of CBL0137 in children with progressive/recurrent diffuse intrinsic pontine glioma (DIPG) and other H3 K27-altered diffuse midline…
Eligibility
- Age range
- 1–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Parts A and B: Patients must be \>= 12 months and =\< 21 years of age at the time of study enrollment * Patients must have had histologic verification of malignancy at original diagnosis or relapse, except in patients with diffuse intrinsic brain stem tumors, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers, including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG) * Part A: Patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases (including u…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureBone Marrow Aspirate
Undergo bone marrow aspirate
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureEchocardiography Test
Undergo ECHO
- DrugFACT Complex-targeting Curaxin CBL0137
Given IV
Locations (35)
- Children's Hospital of AlabamaBirmingham, Alabama
- Phoenix Childrens HospitalPhoenix, Arizona
- Children's Hospital Los AngelesLos Angeles, California
- Children's Hospital of Orange CountyOrange, California
- UCSF Medical Center-Mission BaySan Francisco, California
- Children's Hospital ColoradoAurora, Colorado