Clinical trial NCT00421811: A Study of ADH-1 in Combination With Normothermic Isolated Limb Infusion of Melphalan
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neoplasms
Keywords: cancer
tumors
melanoma
anticarcinogenic agents
antineoplastic agents
cadherins
solid tumors
Lead sponsor: Adherex Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-12
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions
timeFrame: By Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Duke University
name: Doug Tyler, MD
role: PRINCIPAL_INVESTIGATOR
References: