Symptoms and General Pathology

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Melanoma, Cutaneous Malignant

Skin Neoplasms

Disease Attributes

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

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

FACT Complex-targeting Curaxin CBL0137

Joseph Skitzki

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.

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.

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

Median and range baseline subscale and total QOL scores, as well as single item scores, will be presented, followed by mean change scores for subscales, the total scale and single items, compared between different study intervention groups.

The frequency of toxicities will be tabulated by grade across all dose levels. The frequency of toxicities will also be tabulated for the dose estimated to be the maximum tolerated dose.

Responses will be tabulated, and complete response rate will be estimated with its exact 80% confidence interval.

Changes in clinical laboratory values while receiving CBL0137

Incuron

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma	NCT03727789	Advanced Cutane... Advanced Sarcom... Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Recurrent Cutan... Recurrent Sarco... Stage III Soft ... Stage IIIA Soft... Stage IIIB Soft... Stage IV Soft T...	FACT Complex-ta...	18 Years -	Roswell Park Cancer Institute
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma	NCT03727789	Advanced Cutane... Advanced Sarcom... Clinical Stage ... Clinical Stage ... Pathologic Stag... Pathologic Stag... Pathologic Stag... Recurrent Cutan... Recurrent Sarco... Stage III Soft ... Stage IIIA Soft... Stage IIIB Soft... Stage IV Soft T...	FACT Complex-ta...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for advanced cutaneous melanoma of the extremity