Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Rare Diseases

Necrosis

Melanoma

Hyperthermia

Fever

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 Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Melphalan

Interferons

Interferon-gamma

Antiviral Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

melphalan

tumor necrosis factor

interferon-gamma

hyperthermic isolated limb perfusion

Randomized study. Initially, 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study. Subsequently, all patients are randomized to Arms I and II.

Arm I: Regional Hyperthermia plus Regional Single-Agent Chemotherapy. Hyperthermic intravenous limb perfusion, HILP; plus Melphalan, L-PAM, NSC-8806.

Arm II: Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy. HILP as in Arm I; plus L-PAM; and Tumor Necrosis Factor (Knoll), TNF, NSC-635257; Interferon gamma (Genentech), IFN-G, NSC-600662.

Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB) will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion. One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent. The second arm of the study will combine melphalan, tumor necrosis factor, and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100% response rates in a Phase II European trial. Patients will be followed for local response rates, duration of response, treatment toxicity, and disease-free survival.

A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma

National Cancer Institute (NCI)

Nervous System Diseases

Substance Related Disorders

Neoplasm Metastasis

Neurotoxicity Syndromes

Syndrome

Poisoning

Chemically-Induced Disorders

Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.

A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.

Neurofilament light protein measurement in Isolated limb perfused patients

Roger Olofsson Bagge

A prospective feasibility trial initially including 10 patients to investigate if Neurofilament light protein can be detected in peripheral blood in patients undergoing Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive biomarker for neurotoxicity after isolated limb perfusion.

In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of the fact that a relatively mild hyperthermic temperature is used which should be well tolerated by the nerves and other normal tissues in the limbs. It seems probable that the neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity combined with a local effect of a high tourniquet pressure that is used to isolate the blood flow. Prevention of regional and systemic toxicity is essential for improving the outcome after the procedure. It is known that both higher doses of melphalan, higher temperatures and longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading system for the reaction of the normal tissues after ILP and the grading is used as a routine in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid (CSF) during axonal damage and has been shown to be elevated in different forms of dementia. An NfL assay sensitive enough to measure NfL in blood was recently developed. Its concentration reflects axonal injury in both central and peripheral nervous system disorders.The primary aim of this study is to investigate the possibility to measure neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.

Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.

Vastra Gotaland Region

Associate professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma	NCT00001296	Melanoma	melphalan tumor necrosis ... interferon-gamm... hyperthermic is...	-	National Institutes of Health Clinical Center (CC)
Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.	NCT04460053	Malignant Melan...	Neurofilament l...	18 Years -	Vastra Gotaland Region
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma	NCT00001296	Melanoma	melphalan tumor necrosis ... interferon-gamm... hyperthermic is...	-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for hyperthermic isolated limb perfusion