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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

Must not have

Patients with a history of pro-thrombotic disorder

Patients receiving specific drugs to prevent graft-versus-host disease post bone marrow transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests CBL0137, a drug that blocks signals inside cancer cells, in patients whose solid tumors, including CNS tumors or lymphoma, have returned or not responded to treatment. By interfering with the cells' internal communication, the drug aims to stop their growth and cause them to die. CBL0137, also known as Curaxin, has shown antitumor activity in multiple cancers, including glioblastoma, renal cell carcinoma, melanoma, neuroblastoma, and small cell lung cancer.

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.

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.

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.

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I am between 12 and 21 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of blood clotting disorders.

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I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.

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I am taking medication known to increase the risk of a specific heart rhythm problem.

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I do not have any infections that are currently uncontrolled.

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I have been diagnosed with peripheral vascular disease.

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I am not taking medication that strongly affects certain liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

FACT in tumor specimens

Immune response

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~2020

Bone Marrow Aspirate

2015

Completed Phase 3

~40