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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Months - 21 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04870944 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Children's Oncology Group |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
David S Ziegler |
Principal Investigator Affiliation | Pediatric Early Phase Clinical Trial Network |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Australia, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
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 Lymphoma, Recurrent Malignant Solid Neoplasm, Recurrent Primary Malignant Central Nervous System Neoplasm, Refractory Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Primary Malignant Central Nervous System Neoplasm |
PRIMARY OBJECTIVES:
Experimental: Treatment (CBL0137)
Patients receive CBL0137 IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients with pseudoprogression may remain on treatment, as per the treating physician. Patients also undergo ECHO collection of blood samples throughout the trial. Patients may also undergo bone marrow aspirate and/or biopsy as clinically indicated.
Procedure: - Biospecimen Collection
Undergo collection of blood samples
Procedure: - Bone Marrow Aspirate
Undergo bone marrow aspirate
Procedure: - Bone Marrow Biopsy
Undergo bone marrow biopsy
Procedure: - Echocardiography
Undergo ECHO
Drug: - FACT Complex-targeting Curaxin CBL0137
Given IV
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Children's Hospital of Alabama
Birmingham 4049979, Alabama 4829764, 35233
Status
Recruiting
Address
Children's Hospital Los Angeles
Los Angeles 5368361, California 5332921, 90027
Status
Recruiting
Address
Children's Hospital of Orange County
Orange 5379513, California 5332921, 92868
Status
Recruiting
Address
UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921, 94158
Status
Recruiting
Address
Children's Hospital Colorado
Aurora 5412347, Colorado 5417618, 80045
Status
Recruiting
Address
Children's National Medical Center
Washington D.C. 4140963, District of Columbia 4138106, 20010
Status
Recruiting
Address
Johns Hopkins All Children's Hospital
St. Petersburg 4171563, Florida 4155751, 33701
Status
Recruiting
Address
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta 4180439, Georgia 4197000, 30329
Status
Recruiting
Address
Lurie Children's Hospital-Chicago
Chicago 4887398, Illinois 4896861, 60611
Status
Recruiting
Address
Riley Hospital for Children
Indianapolis 4259418, Indiana 4921868, 46202
Status
Recruiting
Address
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore 4347778, Maryland 4361885, 21287
Status
Recruiting
Address
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, 02215
Status
Recruiting
Address
C S Mott Children's Hospital
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Recruiting
Address
University of Minnesota/Masonic Cancer Center
Minneapolis 5037649, Minnesota 5037779, 55455
Status
Recruiting
Address
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678, 64108
Status
Recruiting
Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
Status
Recruiting
Address
Roswell Park Cancer Institute
Buffalo 5110629, New York 5128638, 14263
Status
Recruiting
Address
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York 5128581, New York 5128638, 10032
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10065
Status
Recruiting
Address
New York Medical College
Valhalla 5142090, New York 5128638, 10595
Status
Recruiting
Address
Duke University Medical Center
Durham 4464368, North Carolina 4482348, 27710
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center
Cincinnati 4508722, Ohio 5165418, 45229
Status
Recruiting
Address
Oregon Health and Science University
Portland 5746545, Oregon 5744337, 97239
Status
Recruiting
Address
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927, 19104
Status
Recruiting
Address
Children's Hospital of Pittsburgh of UPMC
Pittsburgh 5206379, Pennsylvania 6254927, 15224
Status
Recruiting
Address
Saint Jude Children's Research Hospital
Memphis 4641239, Tennessee 4662168, 38105
Status
Recruiting
Address
UT Southwestern/Simmons Cancer Center-Dallas
Dallas 4684888, Texas 4736286, 75390
Status
Recruiting
Address
Cook Children's Medical Center
Fort Worth 4691930, Texas 4736286, 76104
Status
Recruiting
Address
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston 4699066, Texas 4736286, 77030
Status
Recruiting
Address
Primary Children's Hospital
Salt Lake City 5780993, Utah 5549030, 84113
Status
Recruiting
Address
Seattle Children's Hospital
Seattle 5809844, Washington 5815135, 98105
Status
Suspended
Address
Sydney Children's Hospital
Randwick 2208285, New South Wales 2155400, 2031