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

This study has been completed.
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00421811
First received: January 10, 2007
Last updated: December 27, 2010
Last verified: December 2010
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


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
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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.
Investigators
Principal Investigator: Doug Tyler, MD Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Study Manager, Adherex Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00421811     History of Changes
Other Study ID Numbers: AHX-01-007
Study First Received: January 10, 2007
Last Updated: December 27, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 18, 2014