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

Phase 1

Completed

• Conditions: Neoplasms

• Registration Number: NCT00421811
• Lead Sponsor: Adherex Technologies, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-12
• Study Start: 2007-04
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-27
• Last Update Posted: 2010-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions	By Week 12

Trial Locations

Locations (7)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

Lehigh Valley Hospital; 🇺🇸 Allentown, Pennsylvania, United States