A Phase 1/2 Study of Tegavivint in Children, Adolescents, and Young Adults with Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
Sponsor: Children's Oncology Group
Enrolling: Male and Female Patients
IRB Number: AAAT9566
U.S. Govt. ID: NCT04851119
Contact: Nobuko Hijiya, MD: 2123059770 / nh2636@cumc.columbia.edu
Additional Study Information: 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, osteosarcomas, liver tumors (HCC and hepatoblastoma), Wilm's tumor and tumors with Wnt pathway aberrations. Tegavivint will be given by vein on Day 1, Day 8, and Day 15 of 28 day cycle for up to 26 cycles, which will last about 24 months. 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. 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 Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations.
This study is closed
Investigator
Nobuko Hijiya, MD
Do You Qualify?
Are you between 12 months (1 year) and 30 years of age? Yes No
Do you have recurrent or refractory solid tumors, including non-Hodgkin lymphoma or desmoid tumors? Yes No
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For more information, please contact:
Nobuko Hijiya, MD
nh2636@cumc.columbia.edu
2123059770