Status:
COMPLETED
A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
Lead Sponsor:
Adherex Technologies, Inc.
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 effe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00421811
Start Date
April 1 2007
End Date
March 1 2009
Last Update
December 28 2010
Active Locations (7)
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1
University of Colorado, Denver
Aurora, Colorado, United States, 80045
2
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
3
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Duke University Medical Center
Durham, North Carolina, United States, 27516