RecruitingPhase 1Phase 2NCT04870944

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

A Phase 1/2 Trial of CBL0137 (NSC# 825802) in Patients With Relapsed or Refractory Solid Tumors Including CNS Tumors and Lymphoma

Sponsor

Children's Oncology Group

Enrollment

63 participants

Start Date

Jan 28, 2022

Study Type

INTERVENTIONAL

Conditions

Recurrent Malignant Solid Neoplasm Refractory Malignant Solid Neoplasm Recurrent Lymphoma Refractory Lymphoma Diffuse Midline Glioma, H3 K27-Altered Metastatic Malignant Neoplasm in the Central Nervous System Recurrent Diffuse Intrinsic Pontine Glioma Recurrent Diffuse Midline Glioma, H3 K27-Altered Recurrent Primary Malignant Central Nervous System Neoplasm Refractory Primary Malignant Central Nervous System Neoplasm

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

Min Age: 12 MonthsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called CBL0137 in children and young adults (ages 1–21) who have solid tumors, brain tumors, or lymphoma that has come back or stopped responding to standard treatments. CBL0137 works by targeting proteins that cancer cells rely on to grow and survive. **You may be eligible if...** - You are between 12 months and 21 years old - You have a confirmed cancer diagnosis (solid tumor, lymphoma, or brain tumor) that has relapsed or is not responding to treatment - Part B patients must have a type of brain tumor called DIPG or H3 K27-altered diffuse midline glioma that has been treated with radiation - Your health status is acceptable (Karnofsky or Lansky score of 50% or higher) - There is no standard cure or proven life-extending treatment available for your condition **You may NOT be eligible if...** - You have not recovered from side effects of previous cancer treatment - You have significant organ dysfunction (heart, liver, kidney) - You cannot meet the minimum time since previous cancer treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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(34)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital of Orange County

Orange, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

New York Medical College

Valhalla, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Sydney Children's Hospital

Randwick, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT04870944

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