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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).


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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).


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

By Week 12

Safety Issue:

No

Principal Investigator

Doug Tyler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Food and Drug Administration

Study ID:

AHX-01-007

NCT ID:

NCT00421811

Start Date:

April 2007

Completion Date:

March 2009

Related Keywords:

  • Neoplasms
  • cancer
  • tumors
  • melanoma
  • anticarcinogenic agents
  • antineoplastic agents
  • cadherins
  • solid tumors
  • Neoplasms

Name

Location

MD Anderson Cancer Center Houston, Texas  77030-4096
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Duke University Medical Center Durham, North Carolina  27710
H. Lee Moffitt Cancer Center Tampa, Florida  33612
Intermountain Medical Center Murray, Utah  84157
University of Colorado, Denver Aurora, Colorado  80045
University of Florida College of Medicine Gainesville, Florida  32610