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

Sponsored by:	Adherex Technologies, Inc.
Information provided by:	Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00421811

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: ADH-1 Drug: melphalan	Phase I Phase II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Melphalan Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment
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).

Further study details as provided by Adherex Technologies, Inc.:

Primary Outcome Measures:

To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions [ Time Frame: By Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	April 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

4 gm IV Days 1 and 8

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421811

Locations

United States, Colorado
University of Colorado, Denver	Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Tracey MacDermott 303-724-2757 Tracey.MacDermott@UCHSC.edu
Principal Investigator: Richardo Gonzalez, MD
United States, Florida
H. Lee Moffitt Cancer Center	Recruiting
Tampa, Florida, United States, 33612
Contact: Sue Rivers, RN 813-745-4923 Sue.Rivers@moffitt.org
Principal Investigator: Jonathan Zager, MD
University of Florida College of Medicine	Recruiting
Gainesville, Florida, United States, 32610
Contact: Cheng Wood 352-265-0111 ext 45122 cheng.wood@surgery.ufl.edu
Principal Investigator: Steven Hochwald, MD
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27516
Contact: Gretchen Mann, RN, BSN 919-684-6858 gretchen.mann.sanders@duke.edu
Principal Investigator: Doug Tyler, MD
United States, Pennsylvania
Lehigh Valley Hospital	Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Susan K. Ayre, RN, MA 610-402-5682 Susan_K.Ayre@lvh.com
Principal Investigator: Paul J. Mosca, MD PhD
United States, Texas
MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Minette E Garcia, RN, BSN minette.garcia@mdanderson.org
Principal Investigator: Merrick Ross, MD
United States, Utah
Intermountain Medical Center	Recruiting
Murray, Utah, United States, 84157
Contact: Tracy Taylor tracy.taylor@imail.org
Principal Investigator: Robert Andtbacka, MD

Sponsors and Collaborators

Adherex Technologies, Inc.

Investigators

Principal Investigator:

Doug Tyler, MD

Duke University

More Information

(Adherex Technologies Inc. Corporate Homepage) This link exits the ClinicalTrials.gov site

Responsible Party:	Adherex Technologies, Inc. ( Clinical Study Manager )
Study ID Numbers:	AHX-01-007
Study First Received:	January 10, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00421811
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adherex Technologies, Inc.:

cancer
tumors
melanoma
anticarcinogenic agents

antineoplastic agents
cadherins
solid tumors

Study placed in the following topic categories:

Melphalan
Melanoma

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs

Myeloablative Agonists
Antineoplastic Agents, Alkylating
Alkylating Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009