About this trial

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.

Eligibility criteria

Qualifiers

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 untreated or progressive) are eligible

Part B: Patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27-altered DMG previously treated with radiation therapy

Disqualifiers

Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control

Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid

Patients who are currently receiving another investigational drug are not eligible

Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Marrow Aspirate
  • Bone Marrow Biopsy
  • Echocardiography Test
  • FACT Complex-targeting Curaxin CBL0137

Treatment groups

63 Participants
are divided into 1 treatment group

Locations

35
Australia
Sydney Children's Hospital2031, RandwickNew South Wales, Australia
United States
Alabama
Children's Hospital of Alabama35233, Birmingham United States
Arizona
Phoenix Childrens Hospital85016, Phoenix United States
California
Children's Hospital Los Angeles90027, Los Angeles United States

Sponsors and collaborators

Children's Oncology Group

Lead sponsor

Incuron LLC

Collaborator