NCT00421811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

December 28, 2010

Status Verified

December 1, 2010

Enrollment Period

1.9 years

First QC Date

January 10, 2007

Last Update Submit

December 27, 2010

Conditions

Neoplasms

Keywords

cancertumorsmelanomaanticarcinogenic agentsantineoplastic agentscadherinssolid tumors

Outcome Measures

Primary Outcomes (1)

  • To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions

    By Week 12

Interventions

ADH-1DRUG

4 gm IV Days 1 and 8

melphalanDRUG

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado, Denver

Aurora, Colorado, 80045, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Duke University Medical Center

Durham, North Carolina, 27516, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Related Links

MeSH Terms

Conditions

NeoplasmsMelanoma

Interventions

Melphalan

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Doug Tyler, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 12, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

December 28, 2010

Record last verified: 2010-12

Locations

US(7)