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Curaxin

CBL0137 for Extremity Melanoma or Sarcoma

Phase 1

Waitlist Available

Led By Joseph Skitzki

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

Patient must have a palpable femoral/radial pulse in the affected extremity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial is testing a new drug (CBL0137) to see what the best dose is and what the side effects are in patients with cancer that has spread to their extremities.

Who is the study for?

This trial is for adults with advanced melanoma or sarcoma in the limbs. Participants must have stable or improving disease, adequate organ function, and no recent major treatments or surgeries. They should not have certain heart conditions, uncontrolled blood pressure, significant infections, untreated brain metastases, HIV/hepatitis B/C infection, or a history of severe reactions to CBL0137 components.Check my eligibility

What is being tested?

The study tests the safety and optimal dosage of CBL0137 for treating extremity melanoma/sarcoma that has spread. It's a phase I trial focusing on how well this drug binds to DNA in tumor cells to inhibit their growth.See study design

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues such as fatigue, nausea, hair loss but may also involve unique risks like allergic reactions to the drug's components and possible effects on liver/kidney functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I can feel the pulse in my leg or arm where I have issues.

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I have melanoma or sarcoma on my limbs that cannot be removed with surgery.

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My sarcoma has not worsened for at least 2 months, and I am not on systemic therapy now.

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My cancer can be measured using scans or calipers.

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My Stage IV cancer was removed or has not worsened after treatment.

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I have not had limb-directed treatment or only had Melphalan therapy without a complete response.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Dose-limiting toxicities (DLTs) defined based on the rate of drug-related grade 3-5 adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (CTCAE) (v.) 5.

Secondary outcome measures

Duration of regional progression free survival (PFS) assessed by RECIST 1.1

Duration of tumor response (both in the field of infusion therapy and out-of-field) assessed by RECIST 1.1

Incidence and type of adverse events assessed using NCI CTCAE v.5

+5 more

Other outcome measures

Melanoma-related symptoms measured using the FACT-M v.4

Melanoma-related symptoms measured using the associated Melanoma Cancer Subscale

Quality of life (QOL) measured using the Functional Assessment of Cancer Therapy - Melanoma (FACT-M v.4) and the associated Melanoma Cancer subscale (MCS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CBL0137)Experimental Treatment1 Intervention

Patients receive FACT complex-targeting curaxin CBL0137 IA over 15 minutes.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

IncuronIndustry Sponsor

3 Previous Clinical Trials

100 Total Patients Enrolled

Roswell Park Cancer InstituteLead Sponsor

403 Previous Clinical Trials

31,279 Total Patients Enrolled

Joseph SkitzkiPrincipal InvestigatorRoswell Park Cancer Institute

2 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Soft Tissue Sarcoma Research Study Groups: Treatment (CBL0137)

Frequently Asked Questions

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

What kind of risks does FACT Complex-targeting Curaxin CBL0137 carry for individuals undergoing treatment?

"Considering the preliminary nature of this Phase 1 trial, Power assigned FACT Complex-targeting Curaxin CBL0137 a score of 1 in terms of safety. This reflects the limited data available for assessing its efficacy and security."

Answered by AI

Is enrollment still open for this research experiment?

"Affirmative. According to clinicaltrials.gov, this trial is actively seeking candidates for participation as of March 18th 2022 and was initially advertised on July 1st 2019. The experiment necessitates 36 volunteers from a single site in order to be completed successfully."

Answered by AI

What is the scope of the clinical trial participants?

"Affirmative. On clinicaltrials.gov, it is stated that this medical trial is actively requiring participants; the original post was made on July 1st 2019 and last updated March 18th 2022. The study seeks to recruit 36 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma

2019. "CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03727789.