Evidence map›Paper›PMID 40543160›Full record

ArticleSurgical oncology2025

A phase 1 study of intra-arterial CBL0137 in extremity melanomas and sarcomas.

Joseph J Skitzki, Minhyung Kim, Daniel T Fisher, John M Kane, Han Yu, Kayla Catalfamo, Garin Tomaszewski, Michael Petroziello, Andrei Purmal, Katerina V Gurova and 1 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Surgical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Regulated cell death programs shaping cancer therapy.Cellular oncology (Dordrecht, Netherlands) · 2026
    Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Joseph J SkitzkiDepartment of General Surgery, Cleveland Clinic, Cleveland, OH, USA. Electronic address: skitzkj@ccf.org.
Minhyung KimDepartment of Immunology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA; Department of Comparative Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Daniel T FisherDepartment of Immunology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
John M KaneDepartment of Surgical Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Han YuDepartment of Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Kayla CatalfamoDepartment of Biostatistics and Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Garin TomaszewskiDepartment of Radiology/Interventional Radiology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Michael PetrozielloDepartment of Radiology/Interventional Radiology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Andrei PurmalIncuron, Inc., Buffalo, NY, USA.
Katerina V GurovaDepartment of Cell Stress Biology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Andrei V GudkovDepartment of Cell Stress Biology, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.

Funding

Two-Spirit Films in Indigenous Cancer HealthP30CA016056 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI Dean G. Tang · 1985 to 2026
$116.6M
Induction of interferon response by chromatin damaging anti-cancer therapyR01CA266216 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI Katerina V Gurova · 2024 to 2026
$1.2M
NCI NIH HHS P30 CA016056NCI NIH HHS R01 CA266216
6 · The paper itself

Abstract

introductionRegional therapies for cancer leverage the ability to isolate the circulation to a diseased extremity or organ and deliver high doses of chemotherapy that would be systemically prohibitive due to toxicity. Virtually all regional therapies utilize the original chemotherapy agent, melphalan, which requires circulatory isolation. CBL0137 is a small molecule with multiple anti-tumor effects when given intra-arterially (IA) that shows similar efficacy to melphalan in preclinical models, but without the need for circulatory isolation. MATERIALS AND

methodsPatients with advanced, unresectable melanoma or sarcoma (n = 5, sarcoma 60 %, melanoma 40 %) of the extremity entered a rapid dose-escalation phase of a clinical trial of IA CBL0137. CBL0137 was administered via a single IA catheter placed proximal to the site of tumor(s) in the affected extremity and delivered over 15 min. Primary objective was to define dose-limiting toxicities with secondary objectives of assessing response and pharmacokinetics (PK).

resultsThe treatments were well tolerated with minimal to no toxicity for all patients. PK data showed predictable, dose-dependent drug exposures with rapid tissue uptake and markedly decreased systemic concentrations as compared to matched intravenous dosing data. CBL0137 preferentially accumulated within tumor tissue as compared to surrounding normal tissue in the infused limb without the need for tourniquet. Sixty percent of patients treated in this protocol would not have been eligible for standard regional therapies with one patient demonstrating prolonged disease stability while avoiding major amputation.

conclusionsThe historic restrictions of standard regional therapies may be overcome with IA CBL0137, and this treatment is potentially applicable to a wide range of cancers beyond the extremities.

Indexed as

ExtremitiesMelanomaSarcomaAdultAgedFemaleFollow-Up StudiesHumansInfusions, Intra-ArterialMaleMiddle AgedPrognosisCBL0137ILIILPMelanomaRegional therapySarcoma

Identifiers

PMID40543160
PMCPMC12632279

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.