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

December 27, 2010 updated by: Adherex Technologies, Inc.

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).

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.

Study Overview

Status

Completed

Conditions

Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado, Denver
- Florida
  - Gainesville, Florida, United States, 32610
    - University of Florida College of Medicine
  - Tampa, Florida, United States, 33612
    - H. Lee Moffitt Cancer Center
- North Carolina
  - Durham, North Carolina, United States, 27516
    - Duke University Medical Center
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - LeHigh Valley Hospital
- Texas
  - Houston, Texas, United States, 77030
    - MD Anderson Cancer Center
- Utah
  - Murray, Utah, United States, 84157
    - Intermountain Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions Time Frame: By Week 12	By Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adherex Technologies, Inc.

Investigators

Principal Investigator: Doug Tyler, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

(Adherex Technologies Inc. Corporate Homepage)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria