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Recruiting Phase 1, Phase 2 NCT04870944

CBL0137 for the Treatment of Relapsed or Refractory Solid Tumors, Including CNS Tumors and Lymphoma

Trial Parameters

Condition Diffuse Midline Glioma, H3 K27-Altered
Sponsor Children's Oncology Group
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 63
Sex ALL
Min Age 12 Months
Max Age 21 Years
Start Date 2022-01-28
Completion 2026-12-31
Interventions
Biospecimen CollectionBone Marrow AspirateBone Marrow Biopsy

Brief 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.

Eligibility Criteria

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 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 * Part A: Patients must have either measurable or evaluable disease * Part B: Patients must have measurable disease * Patient's current disease state must be one for which there is no known cu

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