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Curaxin

CBL0137 for Cancer

Phase 1 & 2
Recruiting
Led By David S Ziegler
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be >= 12 months and =< 30 years of age at the time of study enrollment for Part B2 (relapsed/refractory osteosarcoma)
Patients must have a performance status corresponding to Easter Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

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.

Who is the study for?
This trial is for young people aged 1-21 (up to 30 for certain bone cancers) with solid tumors or lymphoma that have returned or are treatment-resistant. They must have a history of cancer confirmed by tests, meet specific health criteria like kidney function and heart health, and not be pregnant. Treatments must be finished within set time frames before joining.Check my eligibility
What is being tested?
The trial is testing CBL0137's optimal dose and its effects on patients with relapsed/refractory solid tumors including brain/CNS tumors or lymphoma. It aims to block cell signals involved in cancer cell growth and survival, potentially leading to the death of cancer cells.See study design
What are the potential side effects?
Possible side effects include those related to blocking cellular signals which may affect cell division and death; however, specific side effects are not listed as this is an early-phase trial determining safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 30 years old and have relapsed or refractory osteosarcoma.
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I am able to care for myself and perform daily activities.
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My current condition has no cure or treatment to extend life with good quality.
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My kidney, liver, heart functions are normal, and I agree to a central venous catheter.
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I have a solid tumor, lymphoma, or brain cancer that has returned or did not respond to treatment.
Select...
I am between 12 and 21 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-tumor effect of CBL0137 in children with diffuse intrinsic pontine glioma (DIPG) or other H3 K27M-mutant diffuse midline gliomas (Phase II)
Anti-tumor effect of CBL0137 in children with osteosarcomas (Phase II)
Frequency of dose limiting toxicities of CBL0137 (Phase I)
+1 more
Secondary outcome measures
Anti-tumor effect of CBL0137 in children with solid tumors (Phase I)
Area under the drug concentration curve of CBL0137
Frequency of adverse events attributable to CBL0137
Other outcome measures
FACT in tumor specimens
Immune response
Overall survival
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (CBL0137)Experimental Treatment5 Interventions
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 also undergo bone marrow aspirate and/or biopsy at baseline, ECHO prior to cycle 1, and as clinically indicated undergo collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Echocardiography
2013
Completed Phase 4
~11670

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,845 Total Patients Enrolled
30 Trials studying Osteosarcoma
7,759 Patients Enrolled for Osteosarcoma
Incuron LLCUNKNOWN
National Cancer Institute (NCI)NIH
13,667 Previous Clinical Trials
40,926,071 Total Patients Enrolled
103 Trials studying Osteosarcoma
16,479 Patients Enrolled for Osteosarcoma

Media Library

CBL0137 (Curaxin) Clinical Trial Eligibility Overview. Trial Name: NCT04870944 — Phase 1 & 2
Osteosarcoma Research Study Groups: Treatment (CBL0137)
Osteosarcoma Clinical Trial 2023: CBL0137 Highlights & Side Effects. Trial Name: NCT04870944 — Phase 1 & 2
CBL0137 (Curaxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04870944 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
~52 spots leftby Dec 2026