A Phase II Study of PI-88 With Dacarbazine in Patients With Metastatic Melanoma
Metastatic melanoma is a difficult-to-treat cancer for which available treatment options are
limited and minimally effective. Dacarbazine is currently one of the standard chemotherapy
drugs used for the treatment of metastatic melanoma. However, it is associated with low
response rates (10-20%) and median survival of less than 12 months (6-11 months in most
studies). PI-88 is an antiangiogenic and antimetastatic drug that has already shown some
evidence of efficacy when used alone in an intermittent dosage regimen (4 consecutive days
per week) in the treatment of patients with advanced melanoma. The FDA has designated PI-88
as an Orphan Drug for this indication, as well as for Stage III and high-risk stage II
disease. The aim of this randomised pilot phase II trial is to determine whether PI-88 in
combination with a standard regimen of dacarbazine (1000 mg/m2 every 3 weeks) should be
considered for further investigation in a larger-scale trial.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The proportion of patients with objective response or stable disease (non-progression rate) after six treatment cycles
after six treatment cycles
No
Michael Millward, MD
Study Chair
Sir Charles Gairdner Hospital
United States: Food and Drug Administration
PR88205
NCT00130442
June 2005
December 2008
Name | Location |
---|---|
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Arizona Cancer Centre | Tuscon, Arizona 85724 |
University of Colorado Health Science Centre | Denver, Colorado 80010-0510 |