NCT03727789

CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma

A Single-Center Phase I Dose Escalation/Response Trial to Evaluate Safety, Tolerability, and Anti-Tumor Efficacy of Intra-Arterial CBL0137 for Patients With Advanced Extremity Melanoma or Sarcoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies best dose and side effects of CBL0137 in treating patients with extremity melanoma or sarcoma that has spread to other places in the body. Drugs, such as CBL0137, may work by binding to tumor cell deoxyribonucleic acid (DNA) to stop the cell from growing further.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and examine the dose-limiting toxicities of intra-arterial facilitates chromatin transcription (FACT) complex-targeting curaxin CBL0137 (CBL0137) in patients with advanced extremity melanoma or sarcoma. SECONDARY OBJECTIVES: I. To assess the tumor response in advanced melanoma and sarcoma patients treated with intra-arterial administration of CBL0137. II. To define both response in-field (area of the limb distal to the infusion point) and out-of-field (any area proximal to the infusion point) in patients treated with CBL0137 based intra-arterial infusion. III. Assess the pharmacokinetics of CBL0137 in the study population pre-and post CBL0137 intraarterial infusion. IV. Assess tumor protein expression profiles before and after treatment with CBL0137. TERTIARY OBJECTIVES: I. To assess if the proposed treatment has any effect on quality of life as measured by the Functional Assessment of Cancer Therapy ? Melanoma (assessment tool also applicable to sarcoma). OUTLINE: This is a dose-escalation study of FACT complex-targeting curaxin CBL0137. Patients receive FACT complex-targeting curaxin CBL0137 intra-arterially (IA) over 15 minutes. After completion of study treatment, patients are followed up at 2, 6 and 12 weeks, every 3 months for 12 months, then at 24 months.

Conditions

• Advanced Cutaneous Melanoma of the Extremity
• Advanced Sarcoma of the Extremity
• Clinical Stage III Cutaneous Melanoma AJCC v8
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Pathologic Stage IV Cutaneous Melanoma AJCC v8
• Recurrent Cutaneous Melanoma of the Extremity
• Recurrent Sarcoma of the Extremity
• Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IIIA Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IIIB Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8
• Stage IV Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8

Interventions

Type	Name	Description
DRUG	FACT Complex-targeting Curaxin CBL0137	Given IA

Timeline

• Start date: 2019-07-01
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2018-11-01
• Last updated: 2024-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study