A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
Children's Oncology Group
Summary
This phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.
Description
PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of tegavivint administered as an intravenous (IV) infusion over 4 hours, once weekly for 3 weeks, followed by a 1 week rest, in a 28-day cycle to pediatric patients with recurrent/refractory solid tumors, including non-Hodgkin lymphoma and desmoid tumors. (Phase 1 Dose Escalation) II. To preliminarily define antitumor activity of tegavivint in pediatric patients with recurrent or refractory Ewing sarcoma, liver tumors (hepatocellular carcinoma \[HCC\] and hepatoblastoma), osteosarcoma, W…
Eligibility
- Age range
- 1–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * PART A: Patients must be \>= 12 months and =\< 21 years of age at the time of study enrollment * PART B: Patients must be \>= 12 months and =\< 30 years of age at the time of study enrollment * Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse * PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors * PART B: Patients with recurrent or refractory E…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureDual X-ray Absorptiometry
Undergo DEXA scan
- DrugTegavivint
Given IV
- ProcedureX-Ray Imaging
Undergo x-ray imaging
Locations (21)
- Children's Hospital of AlabamaBirmingham, Alabama
- Children's Hospital Los AngelesLos Angeles, California
- Children's Hospital of Orange CountyOrange, California
- Lucile Packard Children's Hospital Stanford UniversityPalo Alto, California
- UCSF Medical Center-Mission BaySan Francisco, California
- Children's Hospital ColoradoAurora, Colorado