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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421811
Recruitment Status : Completed
First Posted : January 12, 2007
Last Update Posted : December 28, 2010
Information provided by:
Adherex Technologies, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: ADH-1 Drug: melphalan Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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).
Study Start Date : April 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: ADH-1
    4 gm IV Days 1 and 8
  • 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

Primary Outcome Measures :
  1. To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions [ Time Frame: By Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421811

United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27516
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
Adherex Technologies, Inc.
Principal Investigator: Doug Tyler, MD Duke University

Additional Information:
Responsible Party: Clinical Study Manager, Adherex Technologies, Inc. Identifier: NCT00421811     History of Changes
Other Study ID Numbers: AHX-01-007
First Posted: January 12, 2007    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: December 2010

Keywords provided by Adherex Technologies, Inc.:
anticarcinogenic agents
antineoplastic agents
solid tumors

Additional relevant MeSH terms:
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs