A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan

N-cadherin, a protein involved in blood vessel cell binding and on the surface of many tumor cells, is increased as cancer progresses. ADH-1 blocks N-cadherin. This study will test the safety and effects of the combination ADH-1 with Normothermic Isolated Limb Infusion of Melphalan in subjects with locally advanced malignant melanoma.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Melanoma Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Colorado, Denver, Aurora, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Signed written informed consent
Male and female patients > or = 18 years of age with diagnosis of melanoma for which treatment with Normothermic Isolated Limb Infusion (ILI) of melphalan would be appropriate
Measurable disease
Disease site(s) must be distal to the planned site of tourniquet placement
Available for immunohistochemical testing of N-cadherin expression tumor tissue
Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG

Exclusion criteria

Receipt of ADH-1 prior to this clinical study (prior melphalan via ILI, is okay)
Stage IV melanoma
Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks before study entry
History of tumors that have shown clinically significant evidence of active bleeding within 12 weeks before study entry
Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities
Allergic reaction to any therapeutic peptide or to melphalan

Treatment and study plan

ADH-1

Drug

4 gm IV Days 1 and 8

melphalan

Drug

By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1

Primary outcomes

To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions

Time frame: By Week 12

Sponsors and collaborators

Lead sponsor

Adherex Technologies, Inc.

Industry

Registry information

Official study title

An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jan 12, 2007
Registry last updated: Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed