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

Neoplasms Clinical Trial

Official title:

An Open-Label, Multicenter, Phase 1/2 Dose Escalation Study to Evaluate Safety, Tolerability and Anti-tumor Activity of Systemic ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan in Subjects With Locally Advanced In-Transit Malignant Melanoma (Adherex Protocol Number AHX-01-007).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421811
• Other study ID #: AHX-01-007
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 10, 2007
• Last updated: December 27, 2010
• Start date: April 2007
• Est. completion date: March 2009

Study information

• Verified date: December 2010
• Source: Adherex Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• ADH-1
4 gm IV Days 1 and 8
• melphalan
By Isolated Limb Infusion (ILI), Lower Extremity: 7.5 mg/L (Limb Volume), Day 1 or Upper Extremity: 10 mg/L (Limb Volume), Day 1

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Adherex Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions		By Week 12	No

External Links

•   (Adherex Technologies Inc. Corporate Homepage)