A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
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
University of Colorado, Denver🇺🇸Aurora, Colorado, United States