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CBL0137 for Cancer
Study Summary
This trial is testing a drug called CBL0137 to see if it can treat patients with solid tumors or lymphoma. The drug works by blocking signals inside cells, which may kill cancer cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are currently taking other medications for cancer, except for leukemia patients taking hydroxyurea.You have had an organ transplant in the past.My cancer has returned or worsened after radiation therapy.I am between 12 and 30 years old and have relapsed or refractory osteosarcoma.My osteosarcoma has come back or didn't respond to treatment.Patients must have a certain level of blood cells.I have a history of blood clotting disorders.I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.I have recovered from side effects of previous cancer treatments.I am able to care for myself and perform daily activities.My cancer can be measured or seen on tests.I am taking medication known to increase the risk of a specific heart rhythm problem.I have specific treatment history requirements, including no prior exposure to CBL0137.My current condition has no cure or treatment to extend life with good quality.You must have had a biopsy to confirm the presence of cancer, unless there are special circumstances.My kidney, liver, heart functions are normal, and I agree to a central venous catheter.I have a solid tumor, lymphoma, or brain cancer that has returned or did not respond to treatment.I have been on a stable or decreasing dose of corticosteroids for at least 7 days.I am between 12 and 21 years old.I do not have any infections that are currently uncontrolled.I have been diagnosed with peripheral vascular disease.I am not taking medication that strongly affects certain liver enzymes.
- Group 1: Treatment (CBL0137)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Across how many different facilities is this research being conducted?
"20 hospitals are currently involved with this study. Some locations include Children's Hospital of Philadelphia, Dana-Farber Cancer Institute, and Saint Jude Children's Research Hospital."
Could you detail the age requirements for this particular clinical trial?
"This particular study is designed for patients aged 12 months to 30 years old. In contrast, there are 841 other studies available for patients under the age of 18 and 4728 for patients over the age of 65."
Are there any inclusionary criteria for this research project?
"This study is looking for 38 participants that have been diagnosed with cancer aged between 12 months and 30 years old. There are several key eligibility requirements that applicants must meet, which are as follows: 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 B1 and B2: Patients must have measurable disease, Parts A and B1: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment, Part B2 (relapsed/refractory osteosar"
Does this experiment currently have any available openings for new participants?
"According to the website clinicaltrials.gov, the last update to this study was on 6/29/2022, which indicates that the trial is not actively recruiting patients. Although this is the case, there are 5263 other studies that are currently enrolling participants."
By what metric will success be measured for this experiment?
"The primary objective of this clinical trial, which will last for a maximum of 21 days, is to assess the anti-tumor effect of CBL0137 in children with diffuse intrinsic pontine glioma (DIPG) or other H3 K27M-mutant diffuse midline gliomas (Phase II). Secondary objectives include measuring the Area under the drug concentration curve of CBL0137, the Minimum serum concentration of CBL0137, and the Frequency of adverse events attributable to CBL0137."
Who else is applying?
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How old are they?
What portion of applicants met pre-screening criteria?
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