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

Completed · Phase 1/Phase 2

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT00421811

Run by

Adherex Technologies, Inc.

People needed

56

Starts

2007-04-01

Expected to finish

2009-03-01

Last updated by the study team

2010-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Colorado, Denver — Aurora, Colorado, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• H. Lee Moffitt Cancer Center — Tampa, Florida, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States

Full record on ClinicalTrials.gov

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