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

NCT ID: NCT00421811

Last Updated: 2010-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

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Conditions

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Neoplasms

Keywords

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cancer tumors melanoma anticarcinogenic agents antineoplastic agents cadherins solid tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ADH-1

4 gm IV Days 1 and 8

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adherex Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Adherex Technologies, Inc.

Principal Investigators

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Doug Tyler, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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University of Colorado, Denver

Aurora, Colorado, United States

Site Status

University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Intermountain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

Related Links

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http://www.adherex.com

(Adherex Technologies Inc. Corporate Homepage)

Other Identifiers

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AHX-01-007

Identifier Type: -

Identifier Source: org_study_id