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

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).

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00421811

Enrollment

Registered

2007-01-12

Start date

2007-04-30

Completion date

2009-03-31

Last updated

2010-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

cancer, tumors, melanoma, anticarcinogenic agents, antineoplastic agents, cadherins, solid tumors

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.

Interventions

DRUGADH-1

4 gm IV Days 1 and 8

DRUGmelphalan

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To tabulate the Best Overall Response according to unconfirmed RECIST, modified for cutaneous lesions	By Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026