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

Adherex Technologies

Status and phase

Completed

Phase 2

Phase 1

Conditions

Neoplasms

Treatments

Drug: melphalan

Drug: ADH-1

Study type

Interventional

Funder types

Industry

Identifiers

NCT00421811

AHX-01-007

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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